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Article of the week: Outcomes of PCNL in England

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Every week the Editor-in-Chief selects the Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

Finally, the third post under the Article of the Week heading on the homepage will consist of additional material or media. This week we feature a video from Mr. Armitage and Mr. Withington discussing their article.

If you only have time to read one article this week, it should be this one

Percutaneous nephrolithotomy in England: practice and outcomes described in the Hospital Episode Statistics database

James N. Armitage, John Withington*†, Jan van der Meulen*‡, David A. Cromwell*, Jonathan Glass†, William G. Finch§, Stuart O. Irving§ and Neil A. Burgess§

Department of Urology, Addenbrooke’s Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, *Clinical Effectiveness Unit, The Royal College of Surgeons of England, †Department of Urology, Guy’s & St Thomas’ NHS Foundation Trust, ‡London School of Hygiene and Tropical Medicine, London, and §Department of Urology, Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, UK

Read the full article
OBJECTIVE

• To investigate the postoperative outcomes of percutaneous nephrolithotomy (PCNL) in English National Health Service (NHS) hospitals.

PATIENTS AND METHODS

• We extracted records from the Hospital Episode Statistics (HES) database for all patients undergoing PCNL between March 2006 and January 2011 in English NHS hospitals.

• Outcome measures were haemorrhage, infection within the index admission, and rates of emergency readmission and in-hospital mortality within 30 days of surgery.

RESULTS

• A total of 5750 index PCNL procedures were performed in 165 hospitals.

• During the index admission, haemorrhage was recorded in 81 patients (1.4%), 192 patients (3.8%) had a urinary tract infection (UTI), 95 patients (1.7%) had fever, and 41 patients (0.7%) had sepsis.

• There were 595 emergency readmissions in 518 patients (9.0%). Reasons for readmission were varied: 70 (1.2%) with UTI, 15 (0.3%) sepsis, 73 (1.3%) haematuria, 25 (0.4%) haemorrhage, and 25 (0.4%) acute urinary retention.

• There were 13 (0.2%) in-hospital deaths within 30 days of surgery.

CONCLUSIONS

• Haemorrhage and infection represent relatively common and potentially severe complications of PCNL.

• Mortality is extremely rare after PCNL (about one in 400 procedures overall) but almost one in 10 patients have an unplanned hospital readmission within 30 days of surgery.

• Complications of PCNL may be under-reported in the HES database and need to be corroborated using other data sources.

 

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Editorial: How are we doing with percutaneous nephrolithotomy in England?

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Over the past several years, with publications of studies evaluating multiple aspects of nephrolithiasis using large databases, our overview of kidney stone disease has vastly expanded. The most recent addition by Armitage et al. [1], published in this issue of BJUI, gives us a view of percutaneous nephrolithotomy (PCNL) outcomes in England that we otherwise would have difficulty seeing without tapping into a database study. Several salient features of this investigation are worth pointing out.

With any study comes the uncertainty of its validity. Evidence-based medicine (EBM) theory dictates we first ask ‘Are the results valid?’ rather than ‘What are the results?’. This study reports similar outcomes to a prior database study of the BAUS, giving us confidence that data from different sources still produce somewhat similar outcomes, hence adding validity to both studies [2]. Moreover, it is further reassuring that the type of epidemiological source of the information was derived from completely different origins, i.e. Armitage et al. [1] used an administrative database from Hospital Episode Statistics (HES) to create their outcomes while the BAUS used a voluntary online prospective database for British surgeons.

The second question that forms the basis of EBM is ‘What are the results?’. The HES data confirmed several findings of PCNL seen in other studies, including in both international series from the Clinical Research Office of the Endourological Society (CROES) as well as American administrative database studies using the Nationwide Inpatient Sample (NIS) [3-5]. Overall complications occur anywhere from 6% to 15% of the time, with the most common complications including infection and bleeding. Compared with these recent studies, the HES study reports lower bleeding, UTI and sepsis rates, which the authors admit could represents an under-reporting phenomenon. Mortality is an exceedingly rare event in all these studies. Overall, complication rates are comparable and give us assurance that they align approximately with other worldwide data. Another important finding with the HES database is the decreased length of stay for patients over time. Lastly, from a physician credentialing standpoint this study has relevant findings. It suggests that the HES administrative database may be a viable source of information to assist in the surgeon validating process.

Weaknesses of administrative database studies include the lack of detail that prospective clinical databases provide. Clinically pertinent PCNL endpoints are inherently absent for both patient and surgical domains. Missing patient information includes stone size, stone-free rates, and patient obesity, which are all reflections of clinical case difficulty. Missing critical surgical information includes where (upper, mid or lower calyx), who (urologist or radiologist) and how (balloon, serial dilators) access is obtained. As mentioned above, the uncertainty of under-coding clinical information always exists.

Why are large database studies, including this article, important? These studies are timely given the recent advocating of retrograde ureteroscopic treatment of large renal calculi [6]. Publication of low complication rates with equal efficacy in an outpatient setting has made ureteroscopic treatment of partial and staghorn renal calculi attractive. Even laparoscopic anatrophic nephrolithotomy has been advocated to further challenge the ‘gold standard’ treatment of PCNL [7]. It is therefore clinically important that British PCNL complication rates are low and that length of stay is decreasing to affirm the role that PCNL has with large renal calculi.

The role of PCNL surgery for renal calculi continues to develop but, more importantly, the value of these large epidemiological studies also continues to grow. They help us to look not only from the ground level but also give us perspective from a different, if not ‘higher’ level, which taken together helps shapes our interpretation of PCNL.

Roger L. Sur

Department of Urology, UC San Diego Health System, San Diego, CA, USA

Read the full article

References

  1. Armitage JN, Withington J, Van der Meulen J et al. Percutaneous nephrolithotomy in England: practice and outcomes described in the hospital episode statistics database. BJU Int 2014; 113: 777–782
  2. Armitage JN, Irving SO, Burgess NA, British Association of Urological Surgeons Section of Endourology. Percutaneous nephrolithotomy in the United Kingdom: results of a prospective data registry. Eur Urol 2012; 61: 1188–1193
  3. de la Rosette J, Assimos D, Desai M et al. The Clinical Research Office of the Endourological Society Percutaneous Nephrolithotomy Global Study: indications, complications, and outcomes in 5803 patients. J Endourol 2011; 25: 11–17
  4. Mirheydar HS, Palazzi KL, Derweesh IH, Chang DC, Sur RL. Percutaneous nephrolithotomy use is increasing in the United States: an analysis of trends and complications. J Endourol 2013; 27: 979–983
  5. Ghani KR, Sammon JD, Bhojani N et al. Trends in percutaneous nephrolithotomy use and outcomes in the United States. J Urol 2013; 190: 558–564
  6. Aboumarzouk OM, Monga M, Kata SG, Traxer O, Somani BK. Flexible ureteroscopy and laser lithotripsy for stones >2 cm: a systematic review and meta-analysis. J Endourol 2012; 26: 1257–1263
  7. Aminsharifi A, Hadian P, Boveiri K. Laparoscopic anatrophic nephrolithotomy for management of complete staghorn renal stone: clinical efficacy and intermediate-term functional outcome. J Endourol 2013; 27: 573–578

 

Video: PCNL practice and outcomes in England

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Percutaneous nephrolithotomy in England: practice and outcomes described in the Hospital Episode Statistics database

James N. Armitage, John Withington*†, Jan van der Meulen*‡, David A. Cromwell*, Jonathan Glass†, William G. Finch§, Stuart O. Irving§ and Neil A. Burgess§

Department of Urology, Addenbrooke’s Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, *Clinical Effectiveness Unit, The Royal College of Surgeons of England, †Department of Urology, Guy’s & St Thomas’ NHS Foundation Trust, ‡London School of Hygiene and Tropical Medicine, London, and §Department of Urology, Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, UK

Read the full article
OBJECTIVE

• To investigate the postoperative outcomes of percutaneous nephrolithotomy (PCNL) in English National Health Service (NHS) hospitals.

PATIENTS AND METHODS

• We extracted records from the Hospital Episode Statistics (HES) database for all patients undergoing PCNL between March 2006 and January 2011 in English NHS hospitals.

• Outcome measures were haemorrhage, infection within the index admission, and rates of emergency readmission and in-hospital mortality within 30 days of surgery.

RESULTS

• A total of 5750 index PCNL procedures were performed in 165 hospitals.

• During the index admission, haemorrhage was recorded in 81 patients (1.4%), 192 patients (3.8%) had a urinary tract infection (UTI), 95 patients (1.7%) had fever, and 41 patients (0.7%) had sepsis.

• There were 595 emergency readmissions in 518 patients (9.0%). Reasons for readmission were varied: 70 (1.2%) with UTI, 15 (0.3%) sepsis, 73 (1.3%) haematuria, 25 (0.4%) haemorrhage, and 25 (0.4%) acute urinary retention.

• There were 13 (0.2%) in-hospital deaths within 30 days of surgery.

CONCLUSIONS

• Haemorrhage and infection represent relatively common and potentially severe complications of PCNL.

• Mortality is extremely rare after PCNL (about one in 400 procedures overall) but almost one in 10 patients have an unplanned hospital readmission within 30 days of surgery.

• Complications of PCNL may be under-reported in the HES database and need to be corroborated using other data sources.

 

Read more articles of the week

Article of the week: Out of the COLD: cryoablation for locally advanced PCa

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Every week the Editor-in-Chief selects the Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

If you only have time to read one article this week, it should be this one

Cryoablation for locally advanced clinical stage T3 prostate cancer: a report from the Cryo-On-Line Database (COLD) Registry

John F. Ward, Christopher J. DiBlasio*, Christopher Williams†, Robert Given‡ and J. Stephen Jones

§The University of Texas MD Anderson Cancer Center, Houston, TX, *Urology, Mount Sinai School of Medicine, Huntington, NY, †Urology, University of Florida and Shands Medical Center, Jacksonville, FL, ‡Urology, Eastern Virginia Medical School, Norfolk, VA, and §Urology, Cleveland Clinic Lerner College of Medicine, Cleveland, OH, USA

Read the full article
OBJECTIVE

• To assess the oncological and functional outcomes of primary prostate cryoablation for men with clinical stage T3 (cT3) prostate cancer, as although radical prostatectomy (RP) or external beam radiotherapy (EBRT) are the standard treatments for locally advanced cT3 prostate cancer some patients opt for nonextirpative prostate cryoablation instead.

PATIENTS AND METHODS

• The Cryo-On-Line Database (COLD) Registry was queried to identify patients with cT3 prostate cancer treated with whole-gland cryoablation (366 patients).

• We assessed biochemical disease-free survival (bDFS) using the Phoenix definition and determined reported rates of urinary incontinence and retention, sexual activity, and rectourethral fistulisation after treatment.

• Patients were subsequently assessed according to whether they were administered neoadjuvant androgen-deprivation therapy or not (ADT; 115 patients, 31.4%).

RESULTS

• For the entire cohort, the 36- and 60-month bDFS rates were 65.3% and 51.9%, respectively.

• Patients who received neoadjuvant ADT had statistically nonsignificantly higher 36- and 60-month bDFS rates (68.0% and 55.4%, respectively) than patients who did not receive neoadjuvant ADT (55.3% and 36.9%, respectively).

• The after treatment urinary incontinence rate was 2.6%; urinary retention rate, 6.0%; sexual activity rate, 30.4%; and rectourethral fistulisation rate, 1.1%.

CONCLUSIONS

• Cryoablation for patients with cT3 prostate cancer leads to less favourable bDFS than that after RP or RT for the same group of men.

• The after treatment rectourethral fistulisation rates for patients with cT3 disease are higher than in those with organ-confined prostate cancer treated with cryoablation; however, urinary dysfunction and sexual activity rates are similar for men with cT3 to those reported from this same registry in men with cT2 disease.

• The addition of neoadjuvant ADT (though not studied prospectively here) should be strongly considered if a patient with cT3 prostate cancer is to be treated with cryoablation.

Read more articles of the week

 

Editorial: Cryosurgery for clinical T3 prostate cancer

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There are limited data available on the outcomes of cryosurgery for clinical T3 prostate cancer, and as such, the role of cryosurgery for clinical T3 disease is currently undetermined [1]. Modern cryosurgery of the prostate, utilizing gas-based third-generation technology, a real-time monitoring system with ultrasonography and thermocouples, is associated with a low complication rate [7], although comparative outcomes of the different treatment modalities and long-term follow-up data remain to be seen.

Several aspects of cryosurgery can make it difficult to adequately control locally advanced prostate cancer. First, cryosurgery for clinical T3 cancer requires unique surgical expertise to control local disease while minimizing side-effects. Secondly, staging of locally advanced prostate cancer is challenging – it is difficult to accurately identify the extent of extracapsular extension, seminal vesicle involvement and/or lymph node metastasis. Thirdly, challenges in managing clinical T3 disease include the requirement of a more extensive ablation technique to appropriately target the extraprostatic disease and seminal vesicle involvement as well as treatment for possible microscopic metastasis, which might not be clinically detectable.

Two recent randomized trials compared outcomes of external beam radiation therapy with those of cryosurgery (including cT3 diseases with use of neo-adjuvant androgen deprivation therapy [ADT]), with contrasting results [2, 3]. Chin et al. [2] reported superiority of biochemical disease-free survival favouring external beam radiation therapy in relatively more advanced (bulky) disease, while Donnelly et al. [3] reported significantly fewer positive biopsy rates favouring cryosurgery in the relatively less advanced disease. These findings could suggest that more advanced bulky cases that require wider local control of bulky extraprostatic diseases are not suitable for cryosurgery, while in appropriately selected cases with fewer extraprostatic diseases, cryosurgery is an acceptable option (when combined with neo-adjuvant ADT). Although appropriately extended cryo-lesions that achieve lethal temperatures can control extraprostatic disease, there is a certain limitation in the extension of cryo-lesions without injury to vital peri-prostate organs, such as the urinary sphincter, rectal wall, bladder wall and ureters.

Evolving accuracy of preoperative diagnostic imaging to assess extraprostatic disease can enhance outcomes, and staging tissue sampling from suspected extraprostatic disease could also identify actual microscopic extension of the extraprostatic disease [4]. A recently updated nomogram predicting lymph node invasion [5] suggests that the probability of lymph node invasion in patients with cT3, PSA level >10 ng/mL, and biopsy primary Gleason grade 4 is 20% or greater. Clearly, the preoperative risk assessment of lymph node involvement using such a modern calculator is pertinent for appropriate patient selection. Finally, management decision should be made by a multidisciplinary team.

When combined with radiotherapy, neo-adjuvant ADT for high-risk and locally advanced prostate cancer has been associated with clinical benefit; however, when combining neo-adjuvant ADT with prostatectomy, there is pathological down-staging and reduction in the surgical positive margin but minimal improvement in overall or disease-free survival [6]. The role of neo-adjuvant and adjuvant ADT when combined with cryosurgery is still unknown. Clearly, a prospective study is needed to determine the optimal duration and method of ADT (whether to use LHRH analogue or combined blockade) and to analyse the side-effects, the quality of life and the cost-effectiveness of a combination of cryosurgery with ADT for cT3a and cT3b prostate cancer.

Osamu Ukimura, Andre Luis de Castro Abreu, Andrew J. Hung and Inderbir S. Gill
USC Institute of Urology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA

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References

  1. Babaian RJ, Donnelly B, Bahn D et al. Best practice statement on cryosurgery for the treatment of localized prostate cancer. J Urol 2008; 180: 1993–2004
  2. Chin JL, Al-Zahrani AA, Autran-Gomez AM, Williams AK, Bauman G. Extended followup oncologic outcome of randomized trial between cryoablation and external beam therapy for locally advanced prostate cancer (T2c-T3b). J Urol 2012; 188: 1170–1175
  3. Donnelly BJ, Saliken JC, Brasher PM et al. A randomized trial of external beam radiotherapy versus cryoablation in patients with localized prostate cancer. Cancer 2010; 116: 323–330
  4. Ukimura O, Coleman JA, de la Taille A et al. Contemporary role of systematic prostate biopsies: indications, techniques, and implications for patient care. Eur Urol 2013; 63: 214–230
  5. Briganti A, Larcher A, Abdollah F et al. Updated nomogram predicting lymph node invasion in patients with prostate cancer undergoing extended pelvic lymph node dissection: the essential importance of percentage of positive cores. Eur Urol 2012; 61: 480–487
  6. Shelley MD, Kumar S, Wilt T, Staffurth J, Coles B, Mason MD. A systematic review and meta-analysis of randomised trials of neo-adjuvant hormone therapy for localised and locally advanced prostate carcinoma. Cancer Treat Rev 2009; 35: 9–17
  7. Ward JF, DiBlasio CJ, Williams C, Given R, Jones JS. Cryoablation for locally advanced clinical stage T3 prostate cancer: a report from the Cryo-On-Line Database (COLD) Registry. BJU Int 2014; 113: 714–718

 

Article of the month: Better QOL with orthotopic neobladders

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Every week the Editor-in-Chief selects the Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

Finally, the third post under the Article of the Week heading on the homepage will consist of additional material or media. This week we feature a video from Dr. Singh of orthotopic neobladder reconstruction by sigmoid colon.

If you only have time to read one article this week, it should be this one

Prospective comparison of quality-of-life outcomes between ileal conduit urinary diversion and orthotopic neobladder reconstruction after radical cystectomy: a statistical model

Vishwajeet Singh, Rahul Yadav, Rahul Janak Sinha and Dheeraj Kumar Gupta
Department of Urology, King George Medical University, Lucknow, Uttar Pradesh, India

Read the full article
OBJECTIVE

• To conduct a prospective comparison of quality-of-life (QoL) outcomes in patients who underwent ileal conduit (IC) urinary diversion with those who underwent orthotopic neobladder (ONB) reconstruction after radical cystectomy for invasive bladder cancers.

PATIENTS AND METHODS

• Between January 2007 and December 2012, 227 patients underwent radical cystectomy and either IC urinary diversion or ONB (sigmoid or ileal) reconstruction.

• Contraindications for ON were impaired renal function (serum creatinine >2 mg/dL), chronic inflammatory bowel disease, previous bowel resection and tumour involvement at the bladder neck/prostatic urethra. Patients who did not have these contraindications chose to undergo either IC or ONB reconstruction, after impartial counselling.

• Baseline characteristics, including demographic profile, body mass index, comorbidities, histopathology of the cystoprostatectomy (with lymph nodes) specimen, pathological tumour stage, postoperative complications, adjuvant therapy and relapse, were recorded and compared.

• The European Organization for Research and Treatment of Cancer QoL questionnaire C30 version 3 was used to analyse QoL before surgery and 6, 12 and 18 months after surgery.

RESULTS

• Of the 227 patients, 28 patients in the IC group and 35 in the ONB group were excluded. The final analysis included 80 patients in the IC and 84 in the ONB group.

• None of the baseline characteristics were significantly different between the groups, except for age, but none of the baseline QoL variables were found to be correlated with age.

• In the preoperative phase, there were no significant differences in any of the QoL domains between the IC or the ONB groups. At 6, 12 and 18 months in the postoperative period, physical functioning (P < 0.001, P < 0.001 and P = 0.001, respectively), role functioning (P = 0.01, P = 0.01 and P = 0.003, respectively), social functioning (P = 0.01, P = 0.01 and P = 0.01, respectively) and global health status/QoL (P < 0.001, P < 0.001 and P = 0.002, respectively) were better in patients in the ONB group than in those in the IC group and the differences were significant.

• The financial burden related to bladder cancer treatment was significantly lower in the ONB group than in the IC group at 6, 12 and 18 months of follow-up (P = 0.05, P = 0.05 and P = 0.005, respectively)

CONCLUSIONS

• ONB is better than IC in terms of physical functioning, role functioning, social functioning, global health status/QoL and financial expenditure.

• ONB reconstruction provides better QoL outcomes than does IC urinary diversion.

Read more articles of the week

 

Editorial: Life is good with orthotopic bladder substitutes!

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In the present issue of the BJUI, Singh et al. [1] present the results of a non-randomized prospective study comprising 80 patients who underwent ileal conduit diversion and 84 who underwent orthotopic bladder substitution. Quality of life was assessed using the European Organisation for the Research and Treatment of Cancer quality-of-life questionnaire, the QLQ-30C, at 6, 12 and 18 months postoperatively. Physical and social functioning and global health status were significantly better in patients with orthotopic bladder substitution than in those who underwent ileal conduit diversion. Moreover, the postoperative financial burden was significantly lower for patients in the orthotopic bladder group than for those in the ileal conduit group, who required stoma appliances, a finding of particular importance not only in India, where the study was performed, but worldwide. The authors’ results are particularly impressive given their use of a questionnaire that included many items (‘Were you short of breath?’, ‘Did you need to rest?’, ‘Have you lacked appetite?’, ‘Have you been constipated?’, ‘Did you feel tense?’, ‘Did you worry’ or ‘Did you feel irritable?’, etc.) that can hardly discriminate between the quality of life of patients who underwent orthotopic bladder substitution and those who underwent ileal conduit diversion. To find significant differences between the two types of urinary diversion, despite such dilution factors, speaks strongly in favour of orthotopic bladder substitution.

The results of this prospective single-centre trial are of particular importance because, as the authors state, other investigators could not show such differences, presumably for a variety of reasons, such as too few patients or single follow-up assessments given at time points that varied from patient to patient. Quality-of-life assessment at similar follow-up time points, as performed by these authors, is important because, with adequate counselling, the postoperative function of orthotopic bladder substitutes improves over time.

Without a doubt, however, a poorly functioning orthotopic bladder substitute may lead to a poorer quality of life than a well-functioning ileal conduit diversion. Poor functional results and life-threatening complications can be largely avoided with ileal orthotopic bladder substitutes, provided the treating urologist has adequate knowledge of the procedure and the patient receives adequate postoperative education [2]. The major ways to ensure good results are:

  • appropriate patient selection (good renal function, regular follow-up possible);
  • the avoidance of damage to the sphincter apparatus and its innervation (individualized nerve-sparing cystectomy, minimum use of bipolar electrocautery near the pelvic plexus and membranous urethra);
  • the use of ileum instead of colon (better compliance) [3-5];
  • the avoidance of a funnel-shaped outlet that can result in kinking, outlet obstruction, residual infected urine and, in the worst case, lifelong need for clean intermittent catheterization (CIC) (Fig. 1).

By contrast to most other urological procedures, orthotopic bladder substitution requires proactive postoperative management [6] to ensure:

  • residual urine-free spontaneous voiding after catheter removal;
  • sterile urine to improve urinary continence and to reduce mucous production [7];
  • the prevention of salt loss syndrome and metabolic acidosis by increased salt intake and sodium bicarbonate substitution in the early postoperative period to ensure a base excess of +2;
  • a systematic increase in functional capacity by progressively expanding voiding intervals to obtain a reservoir capacity of ∼500 mL and, thus, a low end-fill pressure which ensures urinary continence day and night (the latter combined with the use of an alarm clock).

It is equally important to perform lifelong follow-up of patients and regularly at 6- to 12-month intervals so as to diagnose and treat early secondary complications, such as uretero-intestinal strictures or residual, infected urine. If the latter occurs, any form of outlet obstruction, such as ileal mucosa protruding in front of the bladder outlet, strictures or growth of inadvertently left prostatic tissue, must be looked for and treated. In our own experience, secondary outlet obstruction occurred in ∼20% of patients observed for 10 years. This rather high incidence is typical for intestinal bladder substitutes because when voiding, unlike the genuine bladder, there is no coordinated contraction of the reservoir wall which would result in an elevated voiding pressure which, in turn, would overcome an outlet resistance. Bladder substitutes empty mainly by gravitational force alone. If voiding is only possible by abdominal straining, then something must be wrong; therefore, instead of recommending CIC for patients who build up residual and consecutively infected urine, we strongly favour treating the outlet obstruction, usually on an outpatient basis. The avoidance of the need for CIC through surgical technique (no funnel-shaped outlet) and during regular follow-up by treating any potential cause of residual urine can substantially improve the patient’s quality of life. It also avoids the cost of catheters and the risk of infectious complications. Thanks to this active management and removal of any outlet obstruction, 96% of our patients followed for 10 years were still able to void spontaneously [8].

Urs E. Studer
Department of Urology, University Hospital Bern, Bern, Switzerland

Read the full article

References

  1. Singh V, Yadav R, Sinha RJ, Gupta DK. Prospective comparison of quality-of-life outcomes between ileal conduit urinary diversion and orthotopic neobladder reconstruction after radical cystectomy: a statistical model. BJU Int 2014; 113: 726–732
  2. Thurairaja R, Burkhard FC, Studer UE. The orthotopic neobladder. BJU Int 2008; 102: 1307–1313
  3. Berglund B, Kock NG, Myrvold HE. Volume capacity and pressure characteristics of the continent cecal reservoir. Surg Gynecol Obstet 1986; 163: 42–48
  4. Schrier BP, Laguna MP, van der Pal F, Isorna S, Witjes JA. Comparison of orthotopic sigmoid and ileal neobladders: continence and urodynamic parameters. Eur Urol 2005; 47: 679–685
  6. Varol C, Studer UE. Managing patients after an ileal orthotopic bladder substitution. BJU Int 2004; 93: 266–270
  7. Zehnder P, Dhar N, Thurairaja R, Ochsner K, Studer UE. Effect of urinary tract infection on reservoir function in patients with ileal bladder substitute. J Urol 2009; 181: 2545–2549
  8. Thurairaja R, Studer UE. How to avoid clean intermittent catheterization in men with ileal bladder substitution. J Urol 2008; 180: 2504–2509

 

Video: Orthotopic neobladder reconstruction by sigmoid colon

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Prospective comparison of quality-of-life outcomes between ileal conduit urinary diversion and orthotopic neobladder reconstruction after radical cystectomy: a statistical model

Vishwajeet Singh, Rahul Yadav, Rahul Janak Sinha and Dheeraj Kumar Gupta
Department of Urology, King George Medical University, Lucknow, Uttar Pradesh, India

 

Read the full article
OBJECTIVE

• To conduct a prospective comparison of quality-of-life (QoL) outcomes in patients who underwent ileal conduit (IC) urinary diversion with those who underwent orthotopic neobladder (ONB) reconstruction after radical cystectomy for invasive bladder cancers.

PATIENTS AND METHODS

• Between January 2007 and December 2012, 227 patients underwent radical cystectomy and either IC urinary diversion or ONB (sigmoid or ileal) reconstruction.

• Contraindications for ON were impaired renal function (serum creatinine >2 mg/dL), chronic inflammatory bowel disease, previous bowel resection and tumour involvement at the bladder neck/prostatic urethra. Patients who did not have these contraindications chose to undergo either IC or ONB reconstruction, after impartial counselling.

• Baseline characteristics, including demographic profile, body mass index, comorbidities, histopathology of the cystoprostatectomy (with lymph nodes) specimen, pathological tumour stage, postoperative complications, adjuvant therapy and relapse, were recorded and compared.

• The European Organization for Research and Treatment of Cancer QoL questionnaire C30 version 3 was used to analyse QoL before surgery and 6, 12 and 18 months after surgery.

RESULTS

• Of the 227 patients, 28 patients in the IC group and 35 in the ONB group were excluded. The final analysis included 80 patients in the IC and 84 in the ONB group.

• None of the baseline characteristics were significantly different between the groups, except for age, but none of the baseline QoL variables were found to be correlated with age.

• In the preoperative phase, there were no significant differences in any of the QoL domains between the IC or the ONB groups. At 6, 12 and 18 months in the postoperative period, physical functioning (P < 0.001, P < 0.001 and P = 0.001, respectively), role functioning (P = 0.01, P = 0.01 and P = 0.003, respectively), social functioning (P = 0.01, P = 0.01 and P = 0.01, respectively) and global health status/QoL (P < 0.001, P < 0.001 and P = 0.002, respectively) were better in patients in the ONB group than in those in the IC group and the differences were significant.

• The financial burden related to bladder cancer treatment was significantly lower in the ONB group than in the IC group at 6, 12 and 18 months of follow-up (P = 0.05, P = 0.05 and P = 0.005, respectively)

CONCLUSIONS

• ONB is better than IC in terms of physical functioning, role functioning, social functioning, global health status/QoL and financial expenditure.

• ONB reconstruction provides better QoL outcomes than does IC urinary diversion.

Read more articles of the week

 

Article of the week: Preserving sexual function with the prostatic urethral lift

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Every week the Editor-in-Chief selects the Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

Finally, the third post under the Article of the Week heading on the homepage will consist of additional material or media. This week we feature a video from Henry Woo discussing his paper.

If you only have time to read one article this week, it should be this one

Multicentre prospective crossover study of the ‘prostatic urethral lift’ for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia

Anthony L. Cantwell, William K. Bogache*, Steven F. Richardson†, Ronald F. Tutrone‡, Jack Barkin§, James E. Fagelson, Peter T. Chin†† and Henry H. Woo

‡‡Atlantic Urological Associates, Daytona Beach, FL, *Carolina Urological Research Center, Myrtle Beach, SC, †Western Urological Clinic, Salt Lake City, UT, ‡Chesapeake Urology, Baltimore, MD, USA, §University of Toronto, Toronto, ON, Canada, Urology Associates of Denver, Denver, CO, USA, ††Figtree Private Hospital, Figtree, and ‡‡Sydney Adventist Hospital Clinical School, University of Sydney, Sydney, NSW, Australia

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OBJECTIVE

• To assess the clinical effect of the ‘prostatic urethral lift’ (PUL) on lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) through a crossover design study.

PATIENTS AND METHODS

• Men aged ≥50 years with an International Prostate Symptom Score of ≥13, a maximum urinary flow rate (Qmax) of ≤12 mL/s, and a prostate of 30–80 mL were enrolled into a crossover study after completing a prospective, randomised, controlled, ‘blinded’ pivotal study in which they were control subjects receiving a sham procedure.

• Patients were followed for 1 year after crossover PUL at 19 centres in the USA, Canada and Australia. The sham procedure involved rigid cystoscopy with simulated active treatment sounds.

• PUL involved placing permanent UroLift® (NeoTract, Inc., Pleasanton, CA, USA) implants into the lateral lobes of the prostate to enlarge the urethral lumen.

• Urinary symptom relief, health-related quality of life (HRQL) impact, urinary flow parameters, sexual function, and adverse events were assessed and compared between the sham and PUL using paired statistical analysis.

RESULTS

• Symptom, flow, HRQL and sexual function assessments showed response improvements from baseline results, similar to results from other published studies, and most parameters were markedly improved after PUL vs the sham procedure in the same patients.

• Symptom, flow, and HRQL improvements were durable over the 12 months of the study.

• Adverse events associated with the procedure were typically transient and mild to moderate; one patient (2%) required re-intervention with transurethral resection of the prostate in the first year.

• There were no occurrences of de novo, sustained ejaculatory or erectile dysfunction.

CONCLUSION

• The PUL can be performed under local anaesthesia, causes minimal associated perioperative complications, allows patients to quickly return to normal activity, provides rapid and durable improvement in symptoms, and preserves sexual function.

 

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Editorial: Going with the flow! Relieving LUTS and preserving ejaculation

/1 Comment/by

Within the last few months of 2013, the Prostatic Urethral Lift procedure, using the UroLift® implant device (NeoTract, Inc., Pleasonton, CA, USA), appeared on the global urology stage. UroLift has the unusual distinction of being both radically new and yet highly studied. The creative crossover study by Cantwell et al. [1] in the present edition of the BJUI adds to the positive evidence for this new treatment option for men with LUTS. Roehrborn et al. [2] have also recently published a high-quality randomized, blinded study. The accumulating published data indicates a new response profile of rapid relief from LUTS and improved urinary flow, while preserving sexual function, including the often overlooked but much valued benefit of preserving ejaculation. In September 2013, Urolift was approved by the US Food and Drug Administration (FDA) [3] and then subsequently by the National Institute for Health and Care Excellence (NICE) in the UK [4]. Gaining regulatory approval at the first attempt is a strikingly unusual achievement but one we can learn from.

The development of this technique began with initial work in 2005 showing that prostatic glandular tissue could be compressed and tethered to the outer prostatic capsule to open up the prostatic urethra [5]. Neotract and its clinical advisors then embarked on years of device development and iteration, culminating in the current version of the UroLift implant device and the currently preferred technique [6]. The rigorous development and clinical testing programme represents a master class in how a new minimally invasive procedure should be developed.

The process illustrates the benefits of cooperation between active clinicians and expert engineers. One particularly important element in this cooperation was the identification of the critical evidence that would be necessary to overcome regulatory hurdles but also to allow clinicians to understand and evaluate this procedure as they adopt it into practice. Neotract’s determination to produce high-quality data first, rather than publicising the method and developing the data to support it later, represents a refreshing change.

So, get a good and novel idea, develop the engineering, do the high-quality studies, et voila – approval! But is it as easy as that? No, the missing element is finance – lots of it. For a company to tread this recommended path, although required by regulators (and indeed by editors), takes a huge amount of money. An FDA pivotal trial of sufficient quality to convince is likely to cost upwards of $20 m. Few start-up companies or indeed established device companies will take that gamble on truly innovative solutions, particularly when economic conditions are tough. NeoTract and its UroLift technology persevered through the economic crash of 2008 and have continued to achieve key clinical milestones against fierce regulatory and financial headwinds. Given these formidable challenges, it is reasonable to wonder how many other developers with novel ideas would be capable of completing the course. Most, unfortunately, would fail.

for detailed instructions and video.

I encourage you to both review the data of Cantwell et al. [1] in this journal and take a look at the Prostatic Urethral Lift technique, as an innovation that is now available for wider adoption (Fig. 1). It does require judgement to select those most likely to benefit and endoscopic skill to achieve the maximum therapeutic benefit, but it appears to be an effective option for men poorly served by drugs, yet wishing to avoid the negative effects of existing surgical options. Additional studies continue to enrol participants, including a European randomized study, but the evidence currently available greatly exceeds that of most newly introduced minimally invasive developments. Why not take the opportunity to assess it yourself?

Tom McNicholas
Lister Hospital, East and North Hertfordshire NHS Trust, Stevenage, and University of Hertfordshire, Hatfield, UK

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References

  1. Cantwell AL, Bogache WK, Richardson SF et al. Multicentre prospective crossover study of the prostatic Urethral Lift for the treatment of LUTS secondary to BPH. BJU Int 2014; 113: 615–622
  2. Roehrborn CG, Gange SN, Shore ND et al. The prostatic urethral lift for the treatment of lower urinary tract symptoms associated with prostate enlargement due to benign prostatic hyperplasia: the L.I.F.T. study. J Urol 2013; 190: 2162–2167
  3. FDA. FDA News Release: new medical device treats urinary symptoms related to enlarged prostate. Available at: https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm368325.htm. Accessed 14 January 2014
  4. NICE. https://guidance.nice.org.uk/IP/1032. Accessed 15 January 2014
  5. Woo HH, Chin PT, McNicholas TA et al. Safety and feasibility of the prostatic urethral lift: a novel minimally invasive treatment for lower urinary tract symptoms (LUTS) secondary to benign prostatic hypertrophy (BPH). BJU Int 2011; 108: 82–88
  6. McNicholas TA, Woo HH, Chin PT et al. Minimally invasive prostatic urethral lift: surgical technique and multinational study. Eur Urol 2013; 64: 292–299

 

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