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Re: Millin’s prostatectomy in the era of ‘Getting It Right First Time’ and Montgomery: exploring variation in clinical practice and consent

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Letter to the Editor

Millin’s prostatectomy in the era of ‘Get it Right First Time’ and Montgomery: exploring variation in clinical practice and consent.

We read with interest the comment in last months BJUI where it was suggested that the Millin retropubic simple prostatectomy for BPH should be confined to history in part because of the Montgomery ruling and the GIRFT programme [1]. GIRFT was designed to identify variations and raise standards of care. The urology report has since been published (it was not available when the original article was written) and Simon Harrison and his team should be congratulated for providing an excellent review of the current state of urology in the UK and identifying recommendations to improve patient care [2]. As surgeons we are acutely aware how the Montgomery ruling has shifted the test for appropriate consent from the “Bolam principle” to a patient orientated process. It is no longer for us to deem what information is relevant to inform the patient and all risks/benefits/alternatives must be outlined. We should all use a detailed, patient-centred, longitudinal approach to consent supplemented with BAUS information leaflets and other resources.

Where we disagree with the authors is to suggest that both of these key events (GIRFT and Montgomery) can be interpreted as justification for not performing a highly effective operation with excellent outcomes. Terence Millin described the transcapsular retropubic simple prostatectomy in 1945 and it revolutionised the management of men with BPH. There are few other procedures that have survived since their inception over 70 years ago in the same form [3] and it remains an established treatment for large glands in European, British and American urological guidelines respectively. More recently the robotic platform has been utilised to perform the technique, although more frequently a transvesical approach is deployed. When performed by well-trained surgeons it remains a procedure that yields very high patient satisfaction and low complication rates. Whilst accepting the cost implications of the slight increased length of stay the authors have failed to discuss the hidden costs of consumables, increased theatre time and further treatments that may be required for the transurethral enucleation procedures.

HES data shows that Millin prostatectomy is not a commonly performed operation. This reflects the fact that massively enlarged prostates are not as common as in the past, partly due to the widespread use of medical therapy and earlier referrals. However, the management of the extreme end of the enlarged benign prostate will always be challenging and we feel that there remains a need to have surgeons with the necessary skills to perform this procedure in the appropriately selected and consented patient. The largest adenoma enucleated by the authors is 980cc (GW) and we would suggest that this would represent a challenge for any transurethral approach. Indeed, the previous Editor of this journal commented in 2008 “some have said that the era of the Millin prostatectomy is over. I very much disagree with this and would not like to see the demise of such a satisfying surgical procedure, with excellent outcome for the patient” [4].

Andrew Chetwood1, Pravin Menezes2, Charles Coker3, Graham Watson4

1Frimley Health NHS Foundation Trust

2Kingston Hospital NHS Trust

3Brighton and Sussex University Hospitals NHS Trust

4East Sussex Hospitals NHS trust

References

  1. Millin’s prostatectomy in the era of ‘getting it Right First Time’ and Montgomery: exploring variation in clinical practice and consent. Malthouse T, Mistry K, Agrawal S. BJU Int 2018;122:171-172
  2. gettingitrightfirsttime.co.uk
  3. Retropubic prostatectomy; a new extravesical technique; report of 20 cases. Millin Lancet. 1945 Dec 1;2(6380):693-6.
  4. Surgery Illustrated – Millin Retropubic Prostatectomy. Fitzpatrick J, BJU Int 2008;102:906-916
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Reply by the authors

We wholeheartedly agree that the Millin’s is indeed a ‘satisfying surgical procedure, with excellent outcomes for the patient’ and it is not a procedure we would voluntarily relinquish. However as surgeons we should bear in mind the fundamental principles of ‘primum non nocere’ and need to put patient safety above our own wishes to perform a specific operation.  There have been several technological advances since 2008, with HOLEP at the forefront of BPE surgery for large volume glands showing safer and equally effective outcomes.  Indeed Terence Millen was a proponent of transurethral techniques developing his own Millin’s resectoscope, with the retropubic approach only evolving due to a lack of equipment after the world war. He may well have been the first to innovate.

Our article was designed to stimulate a debate around consent, safety, and cost effectiveness in our whole practice. However the principles outlined within GIRFT ideology and the current medicolegal world we live in, remain.   Consent for a Millin’s is clearly an issue with the need to specifically discuss (and document) alternatives including HOLEP, with evidence clearly showing improved safety, lower morbidity and length of stay. Additionally the majority of NHS trusts, have a centre within their region delivering this service and as such not offering HOLEP would not justify performing a Millin’s. Whilst we accept that newer minimally invasive techniques (robotic/laparoscopic with similar safety profiles) also exist and could be retained for the larger glands, we suspect the majority of open retropubic prostatectomies are not for 980cc volume prostates.

Finally, we would argue the fact that HES data shows the Millin’s to be a low volume procedure suggesting many have already changed practice. When considering costs towards consumables, these are incorporated and not in addition to tariffs paid to organisations. As tax paying members of the public and as clinicians we have a responsibility to use our funding and resources wisely. We believe that the literature would benefit from a modern-day case series to better inform this debate. Perhaps we need to define a volumetric cut off above which a retropubic or minimally invasive technique would be justifiable or cost effective?

Sachin Agrawal and Theo Malthouse

Ashford & St Peters NHS Foundation Trust

 

Re: Use of 5α-reductase inhibitors for BPH and risk of high-grade PCa: A French population-based study

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Letter to the Editor

Re: Use of 5α-reductase inhibitors for benign prostate hypertrophy and risk of high-grade prostate cancer: A French population-based study

Sir,

We read with interest the article entitled “Use of 5α-reductase inhibitors for benign prostate hypertrophy and risk of high-grade prostate cancer: A French population-based study” by Scailteux et al. [1]. We appreciate that patients should be informed about the high-grade disease that can develop in patients treated with 5-alpha reductase inhibitor for longer than 2 years.

However, we do not think that the use of the “benign prostatic hypertrophy” phrase, which has been used in nine places, is not correct when the histopathology of the disease is considered. Hypertrophy refers to an increase in cell size, while hyperplasia refers to an increase in cell number. For many years, physicians believed that this condition was caused by an increase in the size of certain cells in the prostate gland. However, studies and histopathological evaluations have shown that this is not a hypertrophy but hyperplasia with new dyes and techniques [2]. “Benign Prostate Hyperplasia” (BPH) is a histopathologically correct expression of benign prostatic enlargement that causes symptoms of lower urinary tract in men. Because the proliferation of stromal and glandular elements is involved in the histopathology of BPH.

When the references made using “hypertrophy” in the article were examined, it was seen that “hypertrophy” was not used in the studies of McConnell et al., and “hyperplasia” was used in both of the articles [3,4]. When the available literature on BPH was searched, it was observed that “hyperplasia” was used and abandonment of the term “hypertrophy” was observed.

As a result, we aimed to warn the editor not to make a clear terminology error in the British Journal of Urology International (BJUI), a respected journal in the field of urology.

Fatih Özkaya, Yılmaz Aksoy and Azam Demirel

Ataturk University Medical Faculty, Department of Urology, Erzurum, Turkey

Read the article

 

References

  1. Scailteux, L.M. et al. Use of 5alpha-reductase inhibitors for benign prostate hypertrophy and risk of high-grade prostate cancer: A French population-based study. BJU Int, 2018.
  2. Vinay Kumar, Abul K. Abbas and Jon C. Aster Male Genital System and Lower Urinary Tract. Robbins Basic Pathology Tenth ed.,2018, p.691-712
  3. McConnell, J.D. et al. The effect of finasteride on the risk of acute urinary retention and the need for surgical treatment among men with benign prostatic hyperplasia. Finasteride Long-Term Efficacy and Safety Study Group. N Engl J Med, 1998. 338(9): p. 557-63.
  4. McConnell, J.D. et al. The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia. N Engl J Med, 2003. 349(25): p. 2387-98.

 

Re: Efficacy and safety of PAE for BPH: an observational study and propensity-matched comparison with TUR of the prostate (the UK- ROPE study)

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Letter to the Editor

Efficacy and safety of prostate artery embolization for benign prostatic hyperplasia: an observational study and propensity-matched comparison with transurethral resection of the prostate (the UK- ROPE study)

Sir,

We read the manuscript by Ray and colleagues and congratulate the authors for the effort spent on this remarkable work. To date, this is the first large multicentre study to assess and compare the efficacy and safety of prostate artery embolization (PAE) for lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) with transurethral resection of the prostate (TURP). We have, however, some concerns regarding the interpretation and reporting of the study that warrant further clarification.

  • It was suggested that the PAE-related learning curve ranges from 10-20 cases. However, even with training and proctorship, the number of PAE each centre had performed to participate in the UK-ROPE Registry was not mentioned. It would be interesting to see a comparison of outcomes between PAE patients who had their procedures performed before and after the learning curve.
  • Unfortunately, due to the large number of centres in UK it was not possible to have a homogenous technique used in the PAE arm. Even considering that the PErFecTED was not used, each centre was allowed to use their own embolization technique.
  • Another technical issue concerns the use of cone-beam CT (CBCT) during the procedures. It is not clear whether CBCT was available and used in every case. For example, it was not mentioned whether penile ulcers were related to embolic agent’s reflux or to anastomoses that were not observed because CBCT was not available or was not used during PAE. All of these issues could be considered bias, however, it has been proven that clinical and imaging success can be achieved with different techniques.
  • Unfortunately, prostate volume measurement data were not available for TURP cases. This information could be important and supportive of the use of TURP, since men are very concerned about prostate volume before and after any therapy.
  • The estimated reported operation rate on and off the 12-month follow-up period was 19.9%. Cases of unilateral embolization, small prostate volume and median lobe enlargement were reported. However, the significance of small prostate volume was not defined, the grade of the median lobe enlargement, as well as if some patients had hypocontractile bladder rather than LUTS. Urodynamic studies might have a key role in this type of evaluation.
  • We understand that transient haematospermia and haematuria should be considered as side effects instead of complications, which could be added to a mail-based questionnaire system used to collect data in the Registry.

The pathophysiology of PAE is probably related to ischemia in the transitional zone of the prostate followed by coagulative necrosis. How was retrograde ejaculation (24.1%) diagnosed in the PAE group? Could it be due to a reduction in ejaculation volume resultant of prostatic tissue death after embolization? Some men stated they had been experiencing retrograde ejaculation prior to PAE due to medication. It seems that ejaculatory status was not captured at baseline. Future investigators should consider the importance of collecting these data preprocedure.

Francisco Cesar Carnevale MD PhD, Andre Moreira de Assis MD and Airton Mota Moreira MD PhD.

Department of Radiology, University of Sao Paulo, Sao Paulo, Brazil.

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Reply by the authors

We thank Carnevale and colleagues for their comments on our study. Regarding the PAE-related learning curve, these data are available and will be published separately. Procedural and screening times and therefore overall radiation dose reduced with increasing experience but there was very little difference in outcome measures in keeping with PAE being a robust technique in many centres and not just the well-known centres of excellence.

Four of the centres were trained and proctored by the Lisbon group and the remaining centres were trained by the University Hospital Southampton IRs using the same technique. The details of catheter and microcatheters used as well as the size and nature of the embolic particles are being published in a subsequent paper. Micro catheters of 2.4Fr and smaller were used in all cases at all centres. The majority of cases were embolized with either particulate PVA (Cook Medical or Boston Scientific) or spherical microspheres (Celonova/Boston Scientific). Cone beam CT was available in almost all centres and was used on the majority of cases. These data are available and are being collated for subsequent publication.

The study protocol and budget allowed normal practice for TURP patients. These did not therefore get formal Urodynamics nor post-surgical imaging and prostate volume measurements. While prostate volume was not formally measured for TURP we recorded resected weights which give some idea of gland volume, though not a reliable measure.

Unilateral embolization, small prostate volume and median lobe enlargement are important co-variates which are being analyzed and will be submitted for publication shortly. All patients having PAE had confirmed obstruction on UDS so hypocontractile bladders were excluded.

We agree that transient haematospermia and haematuria should be considered as side effects instead of complications, and could be added to a mail-based questionnaire system used to collect data in the Registry and we thank Carnevale and colleagues for pointing this out.

Baseline dry or retrograde ejaculation is common in marked prostatic enlargement being treated by alpha blockers such as Tamsulosin. It is a weakness of this study that we did not capture ejaculatory status at baseline. This will be answered in subsequent clinical studies derived from the UK-ROPE dataset.

All of these technical issues were not controlled in our pragmatic study, however, as Carnevale and colleagues note, the study has shown that clinical and imaging success can be achieved with different techniques.

A Ray1, J Powell2,  MJ Speakman3, NT Longford4, R DasGupta5, T Bryant6, S Modi6, J Dyer7, M Harris7, G Carolan-Rees1, N Hacking6

1Cedar, Cardiff University/Cardiff and Vale University Health Board, Cardiff, UK

2Centre for Health Technology Evaluation, National Institute for Health and Care Excellence, London, UK

3Department of Urology, Taunton and Somerset NHS Trust, Taunton, UK

4SNTL Statistics Research and Consulting, Department of Medicine, Imperial College London, London, UK

5Department of Urology, St. Mary’s Hospital, Imperial College Healthcare NHS Trust, London, UK

6Department of Interventional Radiology, Southampton General Hospital, University Hospital Southampton NHS Foundation Trust, Southampton, UK

7Department of Urology, Southampton General Hospital, University Hospital Southampton NHS Foundation Trust, Southampton, UK

 

Re: Transumbilical laparoendoscopic single-site radical prostatectomy and cystectomy with the aid of a transurethral port: a feasibility study

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Letter to the Editor

Transumbilical laparoendoscopic single-site radical prostatectomy and cystectomy with the aid of a transurethral port: a feasibility study

Sir,

We read the article by Su et al describing a new and innovative Zhu‘s transurethral port for performing transumbilical laparoendoscopic single-site radical prostatectomy and cystectomy [1]. We appreciate the authors’ innovation in making LESS urological surgery feasible and simplifying the technically demanding lower tract procedures by the use of a natural urethral orifice as the site of the second port.

However, a few points need due consideration. In the video and the article, details of inserting the Zhu’s port and its use in urethro-vesical suturing are omitted. This detail will be of great benefit to the readers for reproduction of this technique.

From the available literature it has been clear that the urethral stricture rate after transurethral resection of prostate is dependent upon the duration of the procedure (>60 minutes) and the size of the resectoscope used [2, 3]. Similarly, use of an outer sheath of the resectosope of 25.6 Fr by the authors in urethra for such prolonged durations (mean duration of procedures 152 to 328 minutes) may lead to stricture formation [1]. It will be beneficial to know the actual indwelling time of Zhu’s port during the surgery and rate of urethral strictures encountered in long term follow up of these patients.

The use of harmonic scalpel or such energy devices for lateral pedicle dissection in radical prostatectomy have been fraught with a higher risk of erectile dysfunction [4]. The use of a cauterizing device with an inability to perform nerve sparing procedures seems to be another drawback of the use of Zhu’s technique. It will be beneficial to the readers if the authors can mention the rate of erectile dysfunction in their cohort.

 

Read the article

 

Tushit Rai, MBBS, MS

Senior Resident, Department of Urology, PGIMER, Chandigarh

 

Aditya Prakash Sharma, MS, M.Ch

Assistant Professor, Department of Urology, PGIMER, Chandigarh

 

Shrawan K Singh, MS, M.Ch.

Professor, Department of Urology, PGIMER, Chandigarh

 

References

  1. Su J, Zhu Q, Yuan L, Zhang Y, Zhang Q, Wei Y. Transumbilical laparoendoscopic single-site radical prostatectomy and cystectomy with the aid of a transurethral port: a feasibility study. BJU Int 2018; 121(1): 111-8.
  2. Chen ML, Correa AF, Santucci RA. Urethral Strictures and Stenoses Caused by Prostate Therapy. Rev Urol 2016; 18(2): 90-102.
  3. Grechenkov AS, Glybochko PV, Alyaev YG, Bezrukov EA, Vinarov AZ, Butnaru DV, Sukhanov RB. Risk factors for anterior urethral strictures after transurethral resection of benign prostatic hyperplasia.[Article in Russian]. Urologiia 2015; 1: 62-5.
  4. Hefermehl LJ, Largo RA, Hermanns T, Poyet C, Sulser T, Eberli D. Lateral temperature spread of monopolar, bipolar and ultrasonic instruments for robot-assisted laparoscopic surgery. BJU Int 2014; 114(2): 245-52.

Re: Anomalous observations with regard to prostate cancer research

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Letter to the Editor

Anomalous observations with regard to prostate cancer research

Sir,

The article “Anomalous observations with regard to prostate cancer research” [1] was very interesting and informative and I actually agree with all the points raised in that article. Another important observation which may affect the relationship or association between metabolic syndrome (MetS ) and prostate cancer,  is the definition of MetS that is utilized in the various studies. For instance, the WHO definition of MetS uses hyperglycemia or the presence of diabetes mellitus as a mandatory requirement in its definition [2]. If used to define MetS in a study, there would be a very high likelihood of having an inverse relationship between MetS and prostate cancer. This is probably because of the established inverse relationship between diabetes and prostate cancer [3].  On the other hand, if the International Disease Federation (IDF) definition [4], which uses abdominal obesity as a mandatory requirement in its definition of MetS, is used, what would be observed is a more direct proportional relationship between MetS and prostate cancer. This may also be due to the fact that obesity has been associated with increased risk of prostate cancer. In the article by Häggström et al., they actually looked at specific factors of MetS in relation to prostate cancer [5]. They did observe that “hyperglycemia was associated with a decreased risk of prostate cancer while body mass index was associated with increased mortality from prostate cancer”.  Body mass index does correlate positively with measures of central obesity, so if the WHO MetS definition is used to classify their subjects, that inverse relationship comes out but it may not be so if the IDF definition is used. Thank you for your audience.

Read the article

Dr Iya Eze Bassey

Department of Medical Laboratory Sciences, University of Calabar, Calabar, Nigeria

 

References

  1. Hammarsten J. Anomalous observation with regard to prostate cancer in cancer research. BJU Int 2017, 120: 456–457.
  2. World Health Organization. Definition, diagnosis and classification of diabetes mellitus and its complications, report of a WHO consultation. Part 1, diagnosis and classification of Diabetes Mellitus. Geneva: WHO publications, 1999.
  3. Hsing AW, Sakoda LC, Chua JrSC. Obesity, metabolic syndrome, and prostate cancer. Am J Clin Nutr 2007; 86(3): 843S-857S.
  4. Grundy SM, Cleeman JI, Daniels SR et al. American Heart Association; National Heart, Lung, and Blood Institute. Diagnosis and management of the metabolic syndrome, an American Heart Association/National Heart, Lung, and Blood Institute Scientific Statement. Circulation 2005; 112: 2735-2752.
  5. Häggström C, Stocks T, Ulmert D et al. Prospective study on metabolic factors and risk of prostate cancer. Cancer 2012; 118: 6199–206.

 

Reply by the author

Thank you, Dr Iya Eze Bassey, for your points of view. You are quite right. This is really quite complex. You raise the difficulties which arise when you are testing the link between metabolic syndrome (MetS) and incident prostate cancer (PC) using the definitions put forth by the World Health Organizations. There are several difficulties here regarding surrogate measures for PC and MetS if your intention is to explore the link between MetS and its aspects and incident PC and PC pathophysiology.

Firstly, there is emerging evidence that the links between MetS and its aspects and incident PC are negative due to bias mechanisms in reports dominated by low-stage incident PC as is the case when the PC diagnoses are the results of PSA-driven diagnostic procedures. By contrast, the link between MetS and its aspects and incident PC are positive in reports dominated by high-stage PC which often is the case in studies based on symptom-driven diagnostic procedures [1,2].

Secondly, over the years, as you have pointed out MetS in man has been defined in different ways by several health organizations [3]. The practical use of the composite definitions of MetS focuses on its potential value as a risk factor for the development of cardiovascular diseases. It has been claimed by the American Diabetes Association and the European Association for the study of Diabetes, however, that MetS is imprecisely defined and appears to be of limited independent value as a marker of risk for cardiovascular diseases [2]. The definitions put forth by World Health Organizations include a mixture of clinical, anthropometric, haemodynamic, endocrine and metabolic aberrations typically observed in individuals with MetS. The four generally accepted definitions used to define MetS have been put forth by the World Health Organization, the National Cholesterol Education Program, the European Group for the Study of Insulin Resistance and the International Diabetes Foundation. None of these can yet be considered the gold standard, however, because they emphasize different aspects of MetS.

Given the limitations of MetS when it comes to cardiovascular diseases and other aspects of MetS, it is reasonable not to use composite definitions of MetS in PC research, if you are interested in the link between MetS and its aspects and incident PC and PC pathophysiology, simply because MetS as defined by World Health Organizations with a mixture of variables represents a poor surrogate measure for the underlying promoting factor(s) for PC growth. In our research, these established definitions of MetS have not been used. Instead, we have focused on risk factor analyses linking established aspects of MetS, such as prevalence of Type 2 Diabetes and treated hypertension, systolic and diastolic blood pressure, body weight, BMI, waist and hip measurements, waist/hip ratio, fasting insulin, HDL-cholesterol, triglycerides and others, which we think are more robust surrogate measures for metabolic aberrations when it comes to exploring the link between MetS and its aspects and incident PC and PC pathophysiology.

 

Dr Jan Hammersten

Gothenburg, Sweden

 

References

  1. Hammarsten J. Anomalous observation with regard to prostate cancer in cancer research. BJU Int 2017, 120: 456–457.
  2. Hammarsten J, Damber J-E, Haghsheno MA et al. A stage-dependent link between metabolic syndrome and incident prostate cancer. Nature Reviews Urology. In principal accepted for publication.
  3. Kahn R, Buse J, Ferannini E et al. The metabolic syndrome: time for critical appraisal. Joint statement from the American Diabetes Association and the European Association for the study of Diabetes. Diabetologia 48, 1684-1699 (2005).

 

Re: Selective arterial clamping does not improve outcomes in RAPN: a propensity-score analysis of patients without impaired renal function

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Letter to the Editor

Selective arterial clamping does not improve outcomes in RAPN: a propensity-score analysis of patients without impaired renal function

Sir,
With immense interest we have read the article published in your esteemed journal titled “Selective arterial clamping does not improve outcomes in robot-assisted partial nephrectomy (RAPN): a propensity-score analysis of patients without impaired renal function” by Paulucci et al [1]. The strength of this study is that it is the largest comparison of patients undergoing selective arterial clamping (SAC) vs main arterial clamping (MAC) during RAPN to date. The authors have appropriately analysed the database from four medical centres where RAPN were done. They have taken due care to prevent bias by using propensity score analysis. After going through this article we want to discuss a few observations with the authors of this article.

The authors had mentioned that Simmons et al [2] found that renal ischemia does not have a significant effect on renal function when the warm ischemia time (WIT) < 25 min. This might be due to the kidney’s remarkable ability to recruit additional renal function from its nephrons in response to ischemic injury as shown in studies with 99Tc-MAG3 [3]. So it would be logical to think from the above published data that SAC will not have much advantage in terms of renal function preservation following PN when the WIT is < 25 min. The same outcome was derived from the present study also. It would be interesting to know whether SAC is advantageous over MAC in renal function preservation following PN when the WIT > 25 min. The authors should have analysed the outcomes of such patients with WIT > 25 min undergoing MAC vs SAC during RAPN. If the outcome of such analysis shows that SAC is better than MAC in terms of renal function preservation on early or intermediate follow up, then that would be an important message to the existing literature available on the outcome of PN.

The authors should clarify in the statistical analysis and results section, the data mentioned about the patients with WIT < 25 min (n) is 533 MAC patients in pre-propensity-score-matched subset and 122 MAC patients in post-propensity-score-matched subset. But the same data is mentioned differently in Table 1 (520 MAC patients in pre-propensity-score-matched subset and 123 MAC in post-propensity-score-matched subset).

The operating time in MAC group was significantly more compared to SAC group (178 vs 148 min, p value <0.001) in pre-propensity-score-matched subset of patients. Also to note is that estimated blood loss (ml) is more in MAC than the SAC group (75 vs 62.5 ml, p = 0.470) in pre–propensity score matched subjects as mentioned in Table 2. It is logical to think that SAC group should take more time compared with MAC group because in SAC group of patients you need to spend more time to dissect the branches of main renal artery than in MAC group leading to increase in the total operating time and blood loss. The authors should discuss why the operative time and blood loss was less in SAC group. Shao et al [4] in their study on the outcome of laparoscopic partial nephrectomy with segmental artery clamping showed that blood loss and operating time was significantly more in SAC group compared to MAC group.

Read the article

Dr. Varinder Singh Attri, M.S
Senior Resident, Department of Urology, Post Graduate Institute of Medical Education and Research, Chandigarh, India
Dr. Sudheer Kumar Devana, M.S, M.Ch
Assistant Professor, Department of Urology, Post Graduate Institute of Medical Education and Research, Chandigarh, India
Dr. Ravimohan S Mavuduru, M.S, M.Ch
Associate Professor, Department of Urology, Post Graduate Institute of Medical Education and Research, Chandigarh, India
Dr. Girdhar S Bora, M.S, M.Ch
Assistant Professor, Department of Urology, Post Graduate Institute of Medical Education and Research, Chandigarh, India

References

1. Paulucci DJ, Rosen DC, Sfakianos JP, Whalen MJ, Abaza R, Eun DD, Krane LS, Hemal AK and Badani KK Selective arterial clamping does not improve outcomes in robot-assisted partial nephrectomy: a propensity-score analysis of patients without impaired renal function. BJU Int 2017; 119: 430–35. doi:10.1111/bju.13614.
2. Simmons MN, Hillyer SP, Lee BH, Fergany AF, Kaouk J, Campbell SC Functional recovery after partial nephrectomy: effects of volume loss and ischemic injury. J Urol 2012; 187: 1667–73.
3. Zargar H, Akca O, Autorino R et al Ipsilateral renal function preservation after robot-assisted partial nephrectomy (RAPN): an objective analysis using mercapto-acetyltriglycine (MAG3) renal scan data and volumetric assessment. BJU Int 2015; 115: 787–95.
4. Shao P, Qin C, Yin C, Meng X, Ju X, Li J et al Laparoscopic partial nephrectomy with segmental renal artery clamping: technique and clinical outcomes. Eur Urol 2011; 59: 849–55.

 

Reply by the authors

We greatly appreciate the opportunity to respond to Dr.’s Attri, Dvana, Mavuduru, and Bora, who raise several interesting points in regards to our paper. A critical question raised pertains to robotic partial nephrectomies (RPNs) with extended warm ischemia time (WIT), a cohort of patients not well addressed in our study.  Our particular patient database, curated from several experienced surgeons, has few patients with extended WIT with which to evaluate these critical questions raised by the letter authors.  As surgical techniques have advanced to include not only selective arterial clamping (SAC) but also “zero-ischemia”, or super-selective clamping [1], as well as off-clamp techniques [2], the necessity of each innovation must be placed in its proper context. A driving message of our study was the critical importance of understanding that each patient has unique needs.  In the patients in our cohort, with predominantly healthy renal function and two working kidneys, SAC showed no benefit, and we hypothesize that other advanced techniques would similarly show no advantage.  Several other subsets of patients may benefit though from these advanced techniques: in particular patients with solitary kidneys and those with complex masses that would require extended WIT [3]; indeed, future studies are needed to confirm this. In general, however, even in the most complex lesions that undergo robotic partial nephrectomy, the incidence of ischemia time > 30 minutes is uncommon.

We additionally thank the authors for giving us the chance to clarify the error in the table – there were, as correctly stated in the text of the manuscript, 533 main arterial clamping (MAC) patients pre-propensity score matching and 122 MAC patients post-propensity score matching.

We believe the final point raised regarding lower operative time (OT) and estimated blood loss (EBL) in the SAC patients is due to the selection bias inherent in our pre-propensity score matched cohort. Specifically, while prior to matching, lower OT and EBL for SAC counter-intuitively sends the message that SAC compared to MAC is a simpler procedure, we strongly believe that this difference in EBL and OT reflects the underlying selection bias to choose simpler masses for SAC, a bias which we intentionally controlled for using propensity score matching.  In fact, prior to propensity score matching MAC is clearly seen to be used on larger tumors (median 3.1 vs. 2.5 cm).  With the use of propensity score matching, and a robust number of MAC cases with which to perform the subsequent analysis, including many that were equally amenable to either technique, this bias is largely eliminated, with no statistically significant differences (p>0.05) in RENAL score, tumor size, baseline eGFR, patient age, and BMI in post-propensity score matched patients, in turn leading to no difference in operative time (p=0.141) or estimated blood loss (p=0.873).  Crucially, it is only from this cohort from which we drew our conclusions.

 

Sincerely,

Ketan K. Badani and David Paulucci
Icahn School of Medicine at Mount Sinai Hospital, Urology
Daniel Rosen
Harvard Medical School

 

References

  1. Gill IS, Patil MB, de Castro Abreu AL, Ng C, Cai J, Berger A, et al. Zero Ischemia Anatomical Partial Nephrectomy: A Novel Approach. J Urol. Elsevier; 2012 Mar [cited 2017 Apr 30];187(3):807–15.
  2. Kaczmarek BF, Tanagho YS, Hillyer SP, Mullins JK, Diaz M, Trinh Q-D, et al. Off-clamp robot-assisted partial nephrectomy preserves renal function: a multi-institutional propensity score analysis. Eur Urol. 2013 Dec [cited 2015 Jul 28];64(6):988–93.
  3. Tomaszewski JJ, Smaldone MC, Mehrazin R, Kocher N, Ito T, Abbosh P, et al. Anatomic complexity quantitated by nephrometry score is associated with prolonged warm ischemia time during robotic partial nephrectomy. Urology 2014 Aug [cited 2015 Aug 10];84(2):340–4.

 

Re: The Origins of Urinary Stone Disease: Upstream mineral formations initiate downstream Randall’s plaque

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Letter to the Editor

The Origins of Urinary Stone Disease: Upstream mineral formations initiate downstream Randall’s plaque

Sir,

We have read with great interest the paper by Hsi et al.[5] and we would like to comment on this paper with two aims: Firstly, to congratulate the authors on a new observation that could transform our understanding of mineralization processes in the renal papilla, but secondly to voice caution concerning the new hypothesis that they have put forth to explain the formation of Randall’s (interstitial) plaque.

Hsi et al.[5] took renal papillae from non-stone formers undergoing nephrectomy, and analyzed mineral content using micro CT. This means that they were able to visualize mineral throughout each papilla without using the laborious method of serial section. They found intratubular mineral in the outer medulla of all 12 patient papillae that they examined.

Our own studies [1-3], have focused on biopsies of the papilla tip, so we have little data on the outer medulla. However, we have examined the entire medulla in four patients (non-stone formers with no family history of stones) undergoing nephrectomy (two for renal cell carcinoma and two for benign disease) and we have not seen mineral deposits such as Hsi et al.[5] describe but we did not carry out micro CT on those specimens. A more recent report on mineralization in the renal medulla did state that intratubular mineral was seen in the majority of specimens, but no details on these were provided in that study [4]. The presence of microscopic mineral deposits in tubules of the outer medulla by Hsi et al.[5] is an interesting finding, but since the patients studied were not stone formers the implications of such deposits on nephrocalcinosis and renal stones is unclear. Further work on this is certainly required.

In the meantime, we would caution readers that the connection that Hsi et al.[5] make in their paper between mineral deposits in the outer medulla and the formation of Randall’s plaque at the papillary tip is still quite hypothetical. First of all, mineral in kidneys from cancer patients could reflect that disease more than it would necessarily provide data applicable to kidney stones. Secondly, the linking of intratubular mineral in the outer medulla with interstitial mineral at the papilla tip is based solely on the fact that when Hsi et al.[5] observed Randall’s plaque, the intratubular mineral in the outer medulla was especially prevalent. This coincidence, of course, could simply reflect greater crystallization at both locations due to a shared risk factor (such as increased calcium excretion).   In particular, the association between calcifications in both locations they observed need not imply a causal link whereby mineral in the outer medulla leads to mineral at the papilla tip. Finally, the pressure model used by Hsi et al.[5] to explain the deposition of Randall’s plaque at the papilla tip is one that ignores the normal, homeostatic mechanisms controlling blood flow and nephron filtration rates, which are likely to have more control over flow in the tubules of the medulla than would blockage of peripheral nephrons.

In summary, we recognize the findings of Hsi et al.[5] as novel, but urge appropriate caution toward some of their conclusions. The title of their paper notwithstanding, there is much to do to establish that these observations are relevant to mechanisms of kidney stone formation.

 

James E. Lingeman

Amy E. Krambeck

Department of Urology, Indiana University School of Medicine, Indianapolis, IN, USA

Tarek M. El-Achkar

Division of Nephrology, Indiana University School of Medicine, Indianapolis, IN, USA

Andrew P. Evan

James C. Williams, Jr.

Department of Anatomy and Cell Biology, Indiana University School of Medicine, Indianapolis, IN, USA

John C. Lieske

Department of Medicine, Mayo Clinic, Rochester, MN, USA

Elaine M. Worcester

Fredric L. Coe

Renal Section, University of Chicago School of Medicine, Chicago, IL, USA

References

  1. Evan AP, Lingeman JE, Coe FL, Parks JH, Bledsoe SB, Shao Y, Sommer AJ, Paterson RF, Kuo RL and Grynpas M. Randall’s plaque of patients with nephrolithiasis begins in basement membranes of thin loops of henle. J Clin Invest 2003; 111:607-616
  2. Coe FL, Evan AP, Lingeman JE and Worcester EM. Plaque and deposits in nine human stone diseases. Urol Res 2010; 38:239-247
  3. Evan AP, Lingeman JE, Worcester EM, Sommer AJ, Phillips CL, Williams JC, Jr. and Coe FL. Contrasting histopathology and crystal deposits in kidneys of idiopathic stone formers who produce hydroxyapatite, brushite, or calcium oxalate stones. Anat Rec 2014; 297:731-748
  4. Verrier C, Bazin D, Huguet L, Stéphan O, Gloter A, Verpont M-C, Frochot V, Haymann J-P, Brocheriou I, Traxer O, Daudon M and Letavernier E. Topography, composition and structure of incipient randall’s plaque at the nanoscale level. J Urol 2016; 196:1566-1574
  5. Hsi RS, Ramaswamy K, Ho SP and Stoller ML. The origins of urinary stone disease: upstream mineral formations initiate downstream Randall’s plaque. BJUI 2017

 

Reply by the authors

 

Intratubular minerals that were previously unappreciated have been identified in the proximal regions of the renal papilla using non-invasive high resolution X-ray microscopy/tomography. As also observed by Verrier et al., J Urol., 2016 [1], these proximal intratubular minerals do exist and are real. Many groups focus their research exclusively on the distal interstitial papillary minerals, the classic Randall’s plaque (RP). The proximal intratubular minerals cannot be seen endoscopically in contrast to the distal papillary minerals as illustrated in our manuscript.

It is valid to ask if, and how the intratubular biominerals are related to interstitial biominerals; collectively, are they related to stone pathogenesis? Our proposed model was formulated on consistently observed patterns from over 30 renal papillae excised from human kidneys (from cancer and non-cancer non-stone formers, and stone formers). Intratubular minerals were observed in the absence of interstitial biominerals. Conversely, interstitial biominerals were never found without proximal intratubular biominerals. In the absence of a valid animal model, our observations led us to hypothesize that there could be a temporal evolution of papillary biomineralization starting first in the proximal intratubular regions, and progressively mature into the interstitial minerals which are endoscopically visible and often documented/investigated.

What are Randall plaques? This question often is asked by scientists from different disciplines that hear about kidney stones. How are they formed? Are they precursors to kidney stones? The etiology of RP formation has been asked in urology for close to a century. The constant interrogation of the renal tip may not provide all the critical insights into the initiation of stone disease. Several hypotheses have been proposed regarding stone pathogenesis by others. Intratubular formations are based on fundamentals of diffusion and pressure gradients, and physical chemistry approaches. Fundamentally, physical chemistry can explain the sequestration of inorganic on organic and subsequent aggregation of small nanoparticles forming into larger particles. While these approaches can provide insights into interstitial biomineral formations, they also can be applied to explain the uniquely different intratubular biominerals.

Form and function can be used to help explain the formation of intratubular minerals at the levels of the papilla and the nephron as described by Jean Oliver 1968 [2]. Analogous to a stream, where leaves gather along the edges, particulates within the filtrate gather along the sides of the nephrons while maintaining fluid flow at the center of the nephron. This fundamental related to fluid flow can be leveraged at several length scales. We have applied it to the nephron and clusters of nephrons that form a pyramidal-shaped papilla. The collective aspects of linking intratubular with the commonly known interstitial biominerals unite the fields of two distinct yet overlapping disciplines – urology and nephrology. Urologists center their attention on the renal papilla and nephrologists on the nephron of the same papilla. Merging the structure of the nephron to that of the renal papilla will help understand stone pathogenesis, and this forms the basis for the title of our manuscript.

We thank you for providing this opportunity to further elaborate on our recent findings.

 

Sunita P. Ho, PhD

Division of Biomaterials and Bioengineering

School of Dentistry, UCSF

Ryan Hsi, MD

Urologic Surgery

School of Medicine

Vanderbilt University

Marshall Stoller, MD

Department of Urology, UCSF

 

 

References

  1. Verrier C, Bazin D, Huguet L, Stéphan O, Gloter A, Verpont M-C, Frochot V, Haymann J-P, Brocheriou I, Traxer O, Daudon M and Letavernier E. Topography, composition and structure of incipient Randall’s plaque at the nanoscale level. J Urol 2016; 196:1566-1574
  2. Oliver J. Nephrons and kidneys: a quantitative study of development and evolutionary mammalian renal architectonics. New York: Harper & Row; 1968.

 

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Re: Testosterone treatment is not associated with increased risk of prostate cancer or worsening of lower urinary tract symptoms: Prostate health outcomes in the Registry of Hypogonadism in Men (RHYME)

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Letter to the Editor

Re: Testosterone treatment is not associated with increased risk of prostate cancer or worsening of lower urinary tract symptoms: Prostate health outcomes in the Registry of Hypogonadism in Men (RHYME)

 

Dear Sir,

The paper by Frans M.J. Debruyne et al published July 2016 is very interesting [1]. With data from 999 hypogonadism (HG) patients and followed up for 24 months, this study demonstrated again that testosterone replacement therapy (TRT) is not associated with any increased risk of prostate cancer. Findings of this study may also help clarify the decades-long controversy regarding the relationship between testosterone and risk of prostate cancer.  As referred by the authors, many researchers believe that it is the rapid decline rather than the current level of testosterone that might have contributed to the prostate cancer risk [2].  If this hypothesis is true, there is no risk at least in theory to provide TRT for HG patients because the treatment will help these patients to restore their hormone levels. However, we do have one question for the authors: although this study did not find any TRT-related risk for prostate cancer, PSA levels were positively and significantly associated with TRT.  Although the PSA levels for the HG patients who received TRT remained in normal range (<4.0 ng/ml) by the end of the study period, we cannot ignore potential risks since PSA is a significant predictor of prostate cancer. We would like to know authors’ interpretations for this finding.

Conflict of interest statement

We have no conflict of interest to declare.

 

References

[1]        Debruyne FM, Behre HM, Roehrborn CG, et al. Testosterone treatment is not associated with increased risk of prostate cancer or worsening of lower urinary tract symptoms: prostate health outcomes in the Registry of Hypogonadism in Men. BJU international. 2016 Jul 13:

[2]        Xu X, Chen X, Hu H, Dailey AB, Taylor BD. Current opinion on the role of testosterone in the development of prostate cancer: a dynamic model. BMC cancer. 2015: 15:806

 

Yours sincerely,

Kai Wang and  Xinguang Chen

 

Department of Epidemiology, University of Florida

2004 Mowry Road, Gainesville, FL, 32610

*Email: [email protected]

 

Read the full article

 

Re: Robot-assisted partial nephrectomy for the treatment of challenging renal tumors: To get the best recommendation

/by

Letter to the Editor

Robot-assisted partial nephrectomy for the treatment of challenging renal tumors: To get the best recommendation (RE: Comparison of robot-assisted and open partial nephrectomy for completely endophytic renal tumours: a single centre experience)

 

Dear Sir,

With the wide application of robotic surgery in partial nephrectomy (PN), urologists became more interested in assessing its efficacy and safety for the treatment of challenging renal tumors [1-5]. In the current study, Kara and colleagues published the first retrospective  report to compare between robot-assisted partial nephrectomy (RAPN) and open partial nephrectomy (OPN) for the treatment of completely endophytic renal tumors [1]. We congratulate the authors for their valuable work.  15

As expected, they found less blood loss, shorter length of hospital stay, and lower  intraoperative transfusion rates in favor of the robotic group. In fact, the safety and superiority of RAPN over OPN in terms of the intraoperative and perioperative outcomes is no longer a matter of debate. In a recent systematic review and met-analysis, RAPN was found to be an efficient alternative to OPN with the advantages of a low perioperative complication rates, short hospital stay and less blood loss [6]. Despite no RCTs present in this meta-analysis, it confirms the minimally invasive advantages of RAPN over OPN. Recently, in a retrospective matched-pair comparative study between RAPN (n=190) and OPN (n=190) for the treatment of complex renal tumors (RENAL score ≥7), the authors concluded that 35 RAPN is associated with less blood loss (p<0.001), shorter hospital stay (p<0.001) and lower postoperative complication rates (p=0.002); on the other hand, the long-term oncological and functional outcomes at median follow-up (49 and 52 months for RAPN and OPN, respectively) were similar [2]. The treatment of completely endophytic tumors is considered a major challenge to the surgeon. The inaccuracy in identification of tumor extension, the increased risk of vascular entry, and the need for reconstruction of a large parenchymal and pelvicalyceal defect might have a negative influence on the oncologic safety and renal function preservation. However, the introduction of robotic technology and increasing experience in RAPN have allowed for a meticulous dissection of endophytic tumors with intraoperative US guidance, renorrhaphy completion within short time, and improved perioperative outcomes. In experienced hands, when comparing the exophytic, mesophytic and totally endophytic renal tumors, RAPN was found to be safe and feasible procedure in terms of complication rates, functional and oncologic outcomes [3,4]. To our knowledge, the length of WIT is considered a crucial factor affecting the postoperative renal function after PN. The continue evolving in RARP techniques, for example, the sliding-clip renorrhaphy [7], had allowed skillful reconstruction of the large parenchymal and pelvicalyceal defect within safe and acceptable WIT [1-5].    And the important question, what about the long-term oncological and functional difference in estimated glomerular filtration preservation rates and latest functional follow-up between RAPN and OPN. These outcomes were assessed at median follow-up of 15 and 18 months for RAPN and OPN, respectively [1]. This period of follow-up might not be long enough to arrive at a meaningful conclusion regarding the oncologic and functional outcomes of both procedures. Being a retrospective study is one of the limitations in this study; however, we believe that to arrange a well-designed prospective randomized study comparing the robotic and open procedures is a dream difficult to be achieved. In summary, the superiority of RAPN over OPN regarding the perioperative safety has been proven even in challenging cases [1,2,6].  Recent guidelines have poor evidence in recommending the ideal approach to treat large-size, high-complex and/or totally endophytic renal tumors. Thus, the future research directions should be focused on evaluating the long-term outcomes of different PN procedures in order to reach a firm recommendation for treatment of these challenging cases.

 

References: 

  1. Kara O, Maurice MJ, Malkoc E, et al. Comparison of robot-assisted and open partial nephrectomy for completely endophytic renal tumours: a single centre experience. BJU Int. 2016 Aug 1. doi: 10.1111/bju.13572.

2. Wang Y, Shao J, Ma X, Du Q, Gong H, Zhang X. Robotic and open partial  nephrectomy for complex  renal tumors: a matched-pair comparison with a long-term follow-up. World J Urol. 2016.            doi:10.1007/s00345-016-1849-8.

3. Komninos C, Shin TY, Tuliao P et al. Robotic partial nephrectomy for completely endophytic renal tumors: complications and functional and oncologic outcomes during a 4-year median period of follow-up. Urology 2014; 84: 1367–73.

4. Curtiss KM, Ball MW, Gorin MA, Harris KT, Pierorazio PM, Allaf ME. Perioperative outcomes of robotic partial nephrectomy for intrarenal tumors. J Endourol 2015; 29: 293–6.

5. Abdel Raheem A, Alatawi A, Kim DK, et al. Outcomes of high-complexity renal 36 tumours with a Preoperative Aspects and Dimensions Used for an Anatomical (PADUA) score of ≥10 after robot-assisted partial nephrectomy with a median 46.5-month follow-up: a tertiary centre experience. BJU Int. 2016 Apr 22. doi:10.1111/bju.13501.

6. Wu Z, Li M, Liu B, et al. Robotic versus open partial nephrectomy: a systematic 49 review and meta-analysis.

7. Benway BM, Wang AJ, Cabello JM, Bhayani SB. Robotic partial nephrectomy with sliding-clip renorrhaphy: technique and outcomes. Eur Urol, 55 (2009), pp. 592–599

 

 Ali Abdel Raheem and Koon Ho Rha 

Department of Urology and Urological Science Institute, Yonsei University College of Medicine, Seoul, South Korea

Re: Urethral diverticulectomy with Martius fat pad interposition improves symptom resolution and reduces recurrence

/by

Letter to the Editor

Urethral diverticulectomy with Martius fat pad interposition improves symptom resolution and reduces recurrence

Sir,

I read with interest the above paper published online in BJU International,[1] but must take issue with the unjustified ‘tabloid headline’, when a more conventional title describing study design, perhaps “Urethral diverticulectomy with labial fat interposition: a retrospective cohort study”, would be more appropriate.

The term ‘Martius’ graft’ has been used to describe several distinct procedures, the original using bulbocavernosus muscle through a vaginal incision,[2] and most subsequent modifications using subcutaneous fat (+/- muscle +/- skin) dissected from a labial incision.[3, 4]  In both their earlier,[5]and current,[1] publications this group describe a ‘Martius labial fat pad’.  Without wishing to demean Professor Martius’ contribution, the authors might consider calling their procedure either a ‘labial fat graft’, or a ‘modified Martius’ graft’.

The titular statement that “symptom resolution is improved and recurrences reduced” could surely only be claimed on the basis of comparative data, preferably from a randomised study design.  In the methods section the authors describe “analyses using Mann-Whitney U test and Student T-Test” (sic), although no such statistical comparisons are provided in the results.

The authors certainly present enviable outcomes from their procedure, particularly given the case mix described.  However, to say that “the majority of patients had complete resolution of their symptoms” when pain, UTIs, poor flow, frequency/urgency, and stress urinary incontinence (SUI) persisted in 16-59% seems to dismiss the range of symptoms attributable to diverticula rather too lightly.  Most importantly, the authors find 24% new, and 59% persistent SUI, in common with earlier findings,[6] and confirming the minimal impact of labial fat on sphincter function.

Although no comparison is provided in the present paper, the outcomes in their 2009 publication,[5] where selective grafting was used, are not significantly different from routine grafting in the current report.  In the former series, four of the six initial failures were in horseshoe diverticula; if this were included amongst the criteria for grafting then even better results might be anticipated from a selective strategy.

The routine use of grafting might be justified if it were free from risk, but this is clearly not the case.  The authors describe seven complications including two labial haematomata, one abscess, one urethrovaginal fistula and one meatal stricture.  In my own series I have encountered two women sufficiently concerned about labial deformity to seek plastic surgical revision, and two presenting with symptoms of vaginal mass which was not due to recurrence of diverticulum, nor vaginal prolapse, but to swelling of fat within the graft; all required further surgical intervention.

The most common application for interposition grafts in pelvic reconstructive surgery has been obstetric urogenital fistulae, although there has never been high level evidence to support their use in this or other contexts,[7] and recent years have seen a move away from their routine use.[7, 8]  Whilst it does have a place, the associated risks mean it should be done only selectively at the time of urethral diverticulectomy.  The authors’ data would suggest that women with complex (including horse shoe) diverticula, although perhaps not those with SUI, are the ones most likely to benefit.  This question can however only truly be addressed by randomised comparative trial and the authors are well placed to do this in collaboration with other centres undertaking large numbers of complex cases.

 

  1. Malde S, Sihra N, Naaseri S, Spilotros M, Solomon E, Pakzad M, et al. Urethral diverticulectomy with Martius fat pad interposition improves symptom resolution and reduces recurrence. BJU Int. 2016:doi: 10.1111/bju.13579.

 

  1. Martius H. Die operative Wiederherstellung der vollkommen fehlenden Harnrohre und des Schiessmuskels derselben. Zentralblatt fur Gynakologie. 1928;52:480.

 

  1. Sajjadi SG, Hortváth OP, Kalmár K. Martius flap: historical and anatomical considerations. European Journal of Plastic Surgery. 2012;35:711-6.

 

  1. Shaw W. The Martius bulbocavernous interposition operation. British Medical Journal. 1949;2(4639):1261-4.

 

  1. Ockrim JL, Allen DJ, Shah PJ, Greenwell TJ. A tertiary experience of urethral diverticulectomy: diagnosis, imaging and surgical outcomes. BJU Int. 2009;103(11):1550-4.

 

  1. Reeves FA, Inman RD, Chapple CR. Management of symptomatic urethral diverticula in women: a single-centre experience. Eur Urol. 2014;66(1):164-72.

 

  1. de Ridder D, Hilton P, Mourad S, Pickard RS, Rovner ES, Stanford E. Fistulae. In: Abrams P, Cardozo LD, Wein A, editors. Incontinence – ICUD-EAU 5th International Consultation on Incontinence. Geneva, Switzerland: EAU Publications; 2013. p. 1527-79.

 

  1. Browning A. Lack of value of the Martius fibrofatty graft in obstetric fistula repair. Int J Gynaecol Obstet. 2006;93(1):33-7.

 

 

Yours sincerely,

Paul Hilton
Honorary Senior Lecturer in Urogynaecology, Newcastle University, Newcastle upon Tyne, UK; previously Consultant Gynaecologist and Urogynaecologist, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK

 

 

 

Reply by the authors

 

We would like to thank Mr Hilton for his commentary regarding the title of our paper (1). We had indeed initially considered submitting this paper to the Daily Mail but felt upon review that our core readership should be surgeons. Luckily the BJU Int editorial board is young enough to appreciate a punchy headline!

We were enlightened by the brief history lesson on the evolution of the Martius fat pad of which we have all taken note. The authors’ current practice as stated in the paper is to use a modified Martius flap NOT graft because it remains attached to its blood supply.

We have compared symptoms before and after urethral diverticulectomy – and we hope this is clear from the text. The reviewers of this paper did not require the details of our statistical analysis as the results as listed in the table below speak for themselves– however we are delighted to have provoked such interest and provide them with the table below. P value is paired T-Test for all symptoms pre and post surgery. Analysis of each symptom individually by Chi-Squared yield P< 0.001 for all symptoms except FU pre and post surgery.

 

Number Pre-Op Number Post-Op
Mass 48 0 P =0.00016062
Pain 43 8
Dysuria 40 0
Dyspaerunia 37 0
UTIs 32 5
PMD 29 1
Poor flow 19 5
FU 19 10
UD 16 0
SUI 29 17
new SUI 0 5

 

We feel Mr Hilton’s interpretation of our results is unduly pessimistic. Given the recent definition of the term ‘majority’ in the Brexit vote in the UK -the results detailed reveal an outstanding majority. To continue our tabloid theme even the average Daily Mail reader might conclude that resolution of urethral mass in 100%, dysuria in 100%, dyspareunia in 100%, per urethral discharge in 100%, post-voiding dribble in 96%, UTIs in 84%, pain in 81%, poor flow in 76% and frequency/urgency in 63% fits the definition of ‘majority’.

Pre-existing SUI may be a consequence of the urethral diverticulum or more likely a co-pathology – and as such resolution in 41% is very gratifying as diverticulectomy is not a recognised treatment for stress urinary incontinence. New onset SUI persisting at 12 months was only 12% and not the 24% Mr Hilton quotes – and again given our case mix of 80% complex diverticulum this is very gratifying.

The 2009 paper quoted in the letter was a review of only 30 cases from a composite of primary surgeons c.f. this review of 70 cases from a single surgeon in this series (2). The 2009 paper detailed a group with a very different case mix – with 63.3% (19/30) simple diverticulum c.f. only 20% in the current series. Cure was defined symptomatically only and not by prospective MRI and symptoms. The ‘simpler’ nature of this cohort is reflected in the symptomatic outcomes reported including the lower incidence of de novo incontinence – which we have shown to be 0% following excision of a simple urethral diverticulum, and increases with complexity of diverticulum on MRI (3). The 36.7% (11/30) of patients with complex diverticulum in this series required a total of 17 operations for cure. The failures (6/11 -54.5%) reported in this early series were not in those patients operated by the current series authors and no patient in the current series required reoperation for symptomatic urethral diverticulum (0/70 failures).

We have recently published our extensive experience with the modified Martius labial fat pad flap (mMlfpf) interposition (4). In 159 women having this procedure for a variety of indications – 127 (79%) rated the post operative appearance of their labia as good or excellent and only 1 rated it as unsatisfactory. We have had no requests from any of our patients for referral to plastic surgery. There is no such thing as a free lunch (to continue our tabloid theme) or indeed complication free surgery –however mMlfpf appears to be a low morbidity procedure. These findings are corroborated in the recent publication by Phillipe Zimmern’s group who found similarly excellent outcomes in 97 women at a mean of 85 months FU – with only 9% reporting labial asymmetry (5).

We will continue with the ongoing collection of our short and long-term results and endeavour to keep them in the public arena with future publications. We are most interested to hear of Mr Hilton’s complications and experience, and would encourage him to publish his series of urethral diverticulum outcomes to ensure balance and equipoise in the literature.

We thank Mr Hilton for his opinion with regard to the place of the mMlfpf in reconstructive female surgery. Our opinion (backed by our data) is that the use of the mMlfpf significantly reduces symptomatic (1/70 -1.4%) and asymptomatic (1/70 – 1.4%) recurrence) c.f.  the 7/30 (23.3%) symptomatic recurrence in our earlier series, and the 7/30 (23.3%) recurrence rate in the series from Han (6).

This is the largest single surgeon series in the literature. Comparator series with a similar number of complex urethral diverticulum are rare in the literature. The largest single centres series published to date of 2 surgeons experience in 89 diverticulum does not offer a suitable comparator as 72 (80.9%) were simple (7). The only comparable series of note is again from Phillipe Zimmern in which the outcomes of 15 patients with horseshoe diverticulum without routine fat pad interposition are detailed (8). De novo SUI reported in 33% and persistent SUI in 73% – and our de novo SUI rate of 16% and persistent SUI rate of 59% compares favourably and is suggestive of benefit from mMlfpf interposition.

We applaud the suggestion of a randomised control trial, and are more than happy to take part in a national or international study.

 

Yours sincerely,

Tamsin Greenwell 

On behalf of the authors.

 

References:

 

  1. Malde S, Sihra N, Naaseri S, Spilotros M, Solomon E, Pakzad M, et al. Urethral diverticulectomy with Martius fat pad interposition improves symptom resolution and reduces recurrence. BJU Int. 2016:doi: 10.1111/bju.13579.

 

  1. Ockrim JL, Allen DJ, Shah PJ, Greenwell TJ. A tertiary experience of urethral diverticulectomy: diagnosis, imaging and surgical outcomes. BJU Int. 2009;103(11):1550-4.

 

  1. The Effect of MRI Configuration of Urethral Diverticulum on the Incidence of New Onset Urodynamic Stress Urinary Incontinence Following Excision. S Guillaumier, J Jenks, R Hamid, J Ockrim, J Shah, T Greenwell. J Urol 2013; 189 (4): e758 (1846).

 

 

  1. Malde S, Spilotros M, Wilson A, Pakzad M, Hamid R, Ockrim J, Shah PJ, Greenwell T. The uses and outcomes of the Martius fat pad in female urology. World J Urol. 2016 Jul 7. [Epub ahead of print] PMID: 27388009

 

  1. Lee D(1), Dillon BE, Zimmern PE. Long-term morbidity of Martius labial fat pad graft in vaginal reconstruction surgery. Urology 2013; 82(6):1261-6.

 

  1. Han DH, Jeong YS, Choo MS, Lee KS. Outcomes of surgery of female urethral diverticula classified using magnetic resonance imaging. Eur Urol. 2007; 51(6):1664-70.

 

  1. Reeves FA, Inman RD, Chapple CR. Management of symptomatic urethral diverticula in women: a single-centre experience. Eur Urol. 2014;66(1):164-72.

 

  1. Popat S, Zimmern PE. Long-term outcomes after the excision of horseshoe urethral diverticulum. Int Urogynecol J. 2015 Dec 15. [Epub ahead of print]

 

 

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