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Editorial: A novel robotic procedure for bladder outlet obstruction

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We have become used to talking about robotic surgery in urology when we really mean robot‐assisted surgery. The novel aquablation procedure (AquaBeam®) for bladder outlet obstruction (BOO) described by Plante et al. [1] is executed by a robotically controlled waterjet system, conducting a pre‐planned image‐guided resection once the radiological parameters have been entered into the system. This is performed under real‐time ultrasonography guidance. It will deliver a standardized way of carrying out the surgery and will, to a large extent, take away the surgical learning curve whilst introducing a new imaging learning curve.

The present study [1] is an analysis of pre‐planned and exploratory subsets of patients from the WATER study [2], and confirms data from earlier studies [3,4]. The study suggests that, compared with TURP, aquablation is particularly effective in improving both LUTS and bother in the medium‐sized to larger prostate (50–80 mL) and in potentially more challenging prostates such as those with large middle lobes or middle lobe obstruction (judged at pre‐procedure cystoscopy).

It is suggested that the ability to map the resection plane surgically may enable the preservation of key anatomical landmarks and preserve normal sexual function. In this study, anejaculation occurred in only 2% of patients with larger prostates (>50 mL) in the aquablation group compared with 41% of comparable patients undergoing TURP (P < 0.001). The rate of anejaculation however appeared relatively higher in the overall aquablation group, at 10%, compared with 36% in the overall TURP group (P < 0.001). A prostate volume between 30 and 80 mL was an inclusion criterion for the WATER study. This procedure therefore appears to give the best possible rate of anejaculation in a resective surgical intervention in patients with a larger prostate and may have less advantage in patients with a smaller prostate.

Interestingly, the relative overall symptom relief advantage of aquablation over TURP was also not proven in men with smaller prostates; TURP may be equally effective at removing obstructing tissue in smaller as compared to larger prostates. It is not yet clear whether aquablation would not be recommended for prostates below a certain size. In the more recent WATER II study in 101 men with a mean prostate volume of 107 mL, aquablation was also shown to be feasible and safe in men with large prostates (80–150 mL) [5].

There will always be a possible downside to novel treatments and this may relate to poor radiological data entry which may, in turn, lead to sphincter damage, although this has not been an issue in the carefully controlled studies to date. There are also reports of troublesome postoperative bleeding in some cases, although haemostasis can be effectively achieved via a catheter balloon tamponade and traction device or by electrocautery [5,6].

Unlike most other surgical treatments for BOO, the resection times for aquablation are almost independent of prostate volume, although the overall operating time is similar to that of TURP, with the majority of the time being spent in the set up and image planning.

The principal study (WATER) [2] on which this sub‐analysis by Plante et al. is based is an example of a high‐quality randomized controlled trial but still represents data on only 116 patients undergoing aquablation and 65 undergoing TURP; therefore, more randomized controlled trial data and long‐term effectiveness studies are clearly needed. Formal urodynamic studies and trials in patients with even larger prostates would also be appropriate. In addition, there are still few published data on the cost‐effectiveness of aquablation, although it is likely to be in the range of higher‐cost laser ablation therapies.

With better radiology and machine learning or artificial intelligence, this technique may lead to truly standardized BOO surgery with more complete resection and may thereby reduce outcome variability.

References

  1. Plante, M, Gilling, P, Barber, N et al. Symptom relief and anejaculation after aquablation or transurethral resection of the prostate: subgroup analysis from a blinded randomized trial. BJU Int 2019; 123: 651– 60
  2. Gilling, P, Barber, N, Bidair, M et al. WATER: a double‐blind, randomized, controlled trial of Aquablation® vs transurethral resection of the prostate in benign prostatic hyperplasia. J Urol 2018; 199: 1252– 61
  3. Gilling, P, Reuther, R, Kahokehr, A et al. Aquablation ‐ image‐guided robot‐assisted waterjet ablation of the prostate: initial clinical experience. BJU Int 2016; 117: 923– 9
  4. Gilling, P, Anderson, P, Tan, A. Aquablation of the prostate for symptomatic benign prostatic hyperplasia: 1‐year results. J Urol 2017; 197: 1565– 72
  5. Desai, M, Bidair, M, Bhojani, N et al. WATER II (80‐150 mL) procedural outcomes. BJU Int 2019;123: 106– 12
  6. Aljuri, N, Gilling, P, Roehrborn, C. How I do it: balloon tamponade of prostatic fossa following Aquablation. Can J Urol 2017; 24: 8937– 40

 

Article of the week: WATER II (80–150 mL) procedural outcomes

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Every week, the Editor-in-Chief selects an 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 editorial written by a prominent member of the urological community. These are 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.

WATER II (80–150 mL) procedural outcomes

Mihir Desai*, Mo Bidair†, Naeem Bhojani‡, Andrew Trainer§, Andrew Arther§, Eugene Kramolowsky, Leo Doumanian*, Dean Elterman**, Ronald P. Kaufman Jr.††, James Lingeman‡‡, Amy Krambeck‡‡, Gregg Eure§§, Gopal Badlani¶¶, Mark Plante***, Edward Uchio†††, Greg Gin†††, Larry Goldenberg‡‡‡, Ryan Paterson‡‡‡, Alan So‡‡‡, Mitch Humphreys§§§, Claus Roehrborn¶¶¶, Steven Kaplan****, Jay Motola**** and Kevin C. Zorn‡

 

*Institute of Urology, University of Southern California, Los Angeles, †San Diego Clinical Trials, San Diego, CA, USA, ‡University of Montreal Hospital Centre, University of Montreal, Montreal, QC, Canada, §Adult Paediatric Urology and Urogynecology, P.C., Omaha, NE, Virginia Urology, Richmond, VA, USA, **University Health Network University of Toronto, Toronto, ON, Canada, ††Albany Medical College, Albany, NY, ‡‡Indiana University Health Physicians, Indianapolis, IN, §§Urology of Virginia, Virginia Beach, VA, ¶¶Wake Forest School of Medicine,Winston-Salem, NC, ***University of Vermont Medical Centre, Burlington, VT, †††VA Long Beach Healthcare System, Long Beach, CA, USA, ‡‡‡University of British Columbia, Vancouver, BC, Canada, §§§Mayo Clinic Arizona, Scottsdale, AZ, ¶¶¶Department of Urology, UT Southwestern Medical Centre, University of Texas Southwestern, Dallas, TX and ****Icahn School of Medicine at Mount Sinai, New York, NY, USA

 

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Abstract

Objectives

To present early safety and feasibility data from a multicentre prospective study (WATER II) of aquablation in the treatment of symptomatic men with large‐volume benign prostatic hyperplasia (BPH).

Methods

Between September and December 2017, 101 men with moderate‐to‐severe BPH symptoms and prostate volume of 80–150 mL underwent aquablation in a prospective multicentre international clinical trial. Baseline demographics and standardized postoperative management variables were carefully recorded in a central independently monitored database. Surgeons answered analogue scale questionnaires on intra‐operative technical factors and postoperative management. Adverse events up to 1 month were adjudicated by an independent clinical events committee.

Results

The mean (range) prostate volume was 107 (80–150) mL. The mean (range) operating time was 37 (15–97) min and aquablation resection time was 8 (3–15) min. Adequate adenoma resection was achieved with a single pass in 34 patients and with additional passes in 67 patients (mean 1.8 treatment passes), all in a single operating session. Haemostasis was achieved using either a Foley balloon catheter placed in the bladder under traction (n = 98, mean duration 18 h) or direct tamponade using a balloon inflated in the prostate fossa (n = 3, mean duration 15 h). No patient required electrocautery for haemostasis at the time of the primary procedure. The mean length of stay after the procedure was 1.6 days (range same day to 6 days). The Clavien–Dindo grade ≥2 event rate observed at 1 month was 29.7%. Bleeding complications were recorded in 10 patients (9.9%) during the index procedure hospitalization prior to discharge, and included six (5.9%) peri‐operative transfusions.

Conclusions

Aquablation is feasible and safe in treating men with large prostates (80–150 mL). The 6‐month efficacy data are being accrued and will be presented in future publications (ClinicalTrials.gov number, NCT03123250).

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Article of the week: Multicentre international experience of 532‐nm laser PVP with GreenLight XPS in men with very large prostates

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Every week, the Editor-in-Chief selects an 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.

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

Roger Valdivieso*, Pierre‐Alain Hueber*, Malek Meskawi*, Eric Belleville*, Khaled Ajib*, Franck Bruyere†, Alexis E. Te‡, Bilal Chughtai‡, Dean Elterman§, Vincent Misraiand Kevin C. Zorn*

 

*Division of Urology, Centre Hospitalier de l’Universite de Montreal (CHUM), Montreal, QC, Canada, †Department of Urology, CHU, Tours, France, ‡Department of Urology, Cornell University, New York, NY, USA, §Department of Urology, University of Toronto, Toronto, ON, Canada, and Department of Urology, Clinique Pasteur, Toulousse, France

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Abstract

Objectives

To describe peri‐operative results, functional outcomes and complications of laser photoselective vaporization, using the GreenLight system, of prostate glands ≥200 mL in volume.

Methods

Retrospective analysis of a prospectively maintained multicentre database was performed to select a subgroup of patients with very large prostates (volume ≥200 mL) treated with the GreenLight XPS laser. A subgroup of patients with prostate volumes 100–200 mL was used for comparison. International Prostate Symptom Score, maximum urinary flow rate, postvoid residual urine volume and prostate‐specific antigen levels were measured at 6, 12, 24, 36 and 48 months. Durability was evaluated using benign prostatic hyperplasia re‐treatment rate at 12, 24 and 36 months. Additionally, complications were recorded using Clavien–Dindo classification.

Results

A total of 33 patients (38%) had prostates ≥200 mL. Baseline characteristics were similar between patients with prostates ≥200 mL and those with prostates 100–200 mL. Patients with very large prostates (≥200 mL) had longer operating times (129 vs 93 min), less energy delivered, a greater number of fibres used (3 vs 2) and a higher conversion rate to transurethral resection of the prostate (16% vs 4%). In terms of complications and functional outcomes, we did not find any differences between the groups. Retreatment rate was also comparable.

Conclusions

Our results show that PVP GreenLight XPS‐180W is an acceptable technique for very large prostates (≥200 mL); however, operating times, energy delivery, fibres used and conversion to TURP are a concern in this particular subgroup. This should be used for patient counselling and surgery planning.

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Article of the Month: The UK‐ROPE Study

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Every Month, the Editor-in-Chief selects an Article of the Month 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. retainedfirefighter provides more articles like this one. Follow for more articles like this one songsforromance .

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 .

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)

 

Alistair F. Ray*, John Powell†‡, Mark J. Speakman§, Nicholas T. Longford, Ranan DasGupta**, Timothy Bryant††, Sachin Modi††, Jonathan Dyer‡‡, Mark Harris‡‡, Grace Carolan-Rees* and Nigel Hacking††

 

*Cedar, Cardiff University/Cardiff and Vale University Health Board, Cardiff, †Centre for Health Technology Evaluation, National Institute for Health and Care Excellence, London, ‡Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, §Department of Urology, Taunton and Somerset NHS Trust, Taunton, SNTL Statistics Research and Consulting, Department of Medicine, Imperial College London, **Department of Urology, St. Mary’s Hospital, Imperial College Healthcare NHS Trust, London, ††Department of Interventional Radiology, and ‡‡Department of Urology, Southampton General Hospital, University Hospital Southampton NHS Foundation Trust, Southampton, UK

 

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Abstract

Objectives

To assess the efficacy and safety of prostate artery embolization (PAE) for lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) and to conduct an indirect comparison of PAE with transurethral resection of the prostate (TURP).

Patients and Methods

As a joint initiative between the British Society of Interventional Radiologists, the British Association of Urological Surgeons and the National Institute for Health and Care Excellence, we conducted the UK Register of Prostate Embolization (UK‐ROPE) study, which recruited 305 patients across 17 UK urological/interventional radiology centres, 216 of whom underwent PAE and 89 of whom underwent TURP. The primary outcomes were International Prostate Symptom Score (IPSS) improvement in the PAE group at 12 months post‐procedure, and complication data post‐PAE. We also aimed to compare IPSS score improvements between the PAE and TURP groups, using non‐inferiority analysis on propensity‐score‐matched patient pairs. The clinical results and urological measurements were performed at clinical sites. If you want more articles like this one follow us at salbreux-pesage . IPSS and other questionnaire‐based results were mailed by patients directly to the trial unit managing the study. All data were uploaded centrally to the UK‐ROPE study database.

Results

The results showed that PAE was clinically effective, producing a median 10‐point IPSS improvement from baseline at 12 months post‐procedure. PAE did not appear to be as effective as TURP, which produced a median 15‐point IPSS score improvement at 12 months post‐procedure. These findings are further supported by the propensity score analysis, in which we formed 65 closely matched pairs of patients who underwent PAE and patients who underwent TURP. In terms of IPSS and quality‐of‐life (QoL) improvement, there was no evidence of PAE being non‐inferior to TURP. Patients in the PAE group had a statistically significant improvement in maximum urinary flow rate and prostate volume reduction at 12 months post‐procedure. PAE had a reoperation rate of 5% before 12 months and 15% after 12 months (20% total rate), and a low complication rate. Of 216 patients, one had sepsis, one required a blood transfusion, four had local arterial dissection and four had a groin haematoma. Two patients had non‐target embolization that presented as self‐limiting penile ulcers. Additional patient‐reported outcomes, pain levels and return to normal activities were very encouraging for PAE. Seventy‐one percent of PAE cases were performed as outpatient or day cases. In contrast, 80% of TURP cases required at least 1 night of hospital stay, and the majority required 2 nights.Here excelpasswordrecovery you can check the best articles of the month.

Conclusion

Our results indicate that PAE provides a clinically and statistically significant improvement in symptoms and QoL, although some of these improvements were greater in the TURP arm. The safety profile and quicker return to normal activities may be seen as highly beneficial by patients considering PAE as an alternative treatment to TURP, with the concomitant advantages of reduced length of hospital stay and need for admission after PAE. PAE is an advanced embolization technique demanding a high level of expertise, and should be performed by experienced interventional radiologists who have been trained and proctored appropriately. The use of cone‐beam computed tomography is encouraged to improve operator confidence and minimize non‐target embolizations. The place of PAE in the care pathway is between that of drugs and surgery, allowing the clinician to tailor treatment to individual patients’ symptoms, requirements and anatomical variation.

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Article of the Week: TIND implantation in benign prostatic obstruction

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Every Week, the Editor-in-Chief selects an 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 podcast discussing the paper.

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

3‐Year follow‐up of temporary implantable nitinol device implantation for the treatment of benign prostatic obstruction

 

Francesco Porpiglia , Cristian Fiori, Riccardo Bertolo, Andrea Giordano, Enrico Checcucci, Diletta Garrou, Giovanni Cattaneo, Stefano De Luca and Daniele Amparore
Division of Urology, Department of Oncology – School of Medicine, San Luigi Hospital, University of Turin, Orbassano (Turin), Italy

 

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Abstract

Objectives

To report 3‐year follow‐up results of the first implantations with a temporary implantable nitinol device (TIND®; Medi‐Tate Ltd., Or Akiva, Israel) for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).

Patients and Methods

In all, 32 patients with LUTS were enrolled in this prospective study. The study was approved by the local Ethics Committee. Inclusion criteria were: age >50 years, International Prostate Symptom Score (IPSS) ≥10, peak urinary flow (Qmax) <12 mL/s, and prostate volume <60 mL. The TIND was implanted within the bladder neck and the prostatic urethra under light sedation, and removed 5 days later in an outpatient setting. Demographics, perioperative results, complications (according to Clavien–Dindo classification), functional results, and quality of life (QoL) were evaluated. Follow‐up assessments were made at 3 and 6 weeks, and 3, 6, 12, 24 and 36 months after the implantation. The Student’s t‐test, one‐way analysis of variance and Kruskal–Wallis tests were used for statistical analyses.

Results

At baseline, the mean (standard deviation, sd) patient age was 69.4 (8.2) years, prostate volume was 29.5 (7.4) mL, and Qmax was 7.6 (2.2) mL/s. The median (interquartile range, IQR) IPSS was 19 (14–23) and the QoL score was 3 (3–4). All the implantations were successful, with a mean total operative time of 5.8 min. No intraoperative complications were recorded. The change from baseline in IPSS, QoL score and Qmax was significant at every follow‐up time point. After 36 months of follow‐up, a 41% rise in Qmax was achieved (mean 10.1 mL/s), the median (IQR) IPSS was 12 (6–24) and the IPSS QoL was 2 (1–4). Four early complications (12.5%) were recorded, including one case of urinary retention (3.1%), one case of transient incontinence due to device displacement (3.1%), and two cases of infection (6.2%). No further complications were recorded during the 36‐month follow‐up.

Conclusions

The extended follow‐up period corroborated our previous findings and suggests that TIND implantation is safe, effective and well‐tolerated, for at least 36 months after treatment.

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Editorial: The trials of doing trials: will the prostatic stent rise from the dead?

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A further re‐engineering of the prostatic stent (temporary implantable nitinol device [TIND®, Medi‐Tate Ltd., Israel]) is reported by Porpiglia et al. 1 in this edition of the BJUI. Enthusiasm for novel ‘minimally invasive’ treatments for BPH/LUTs has surged recently, with new options supported by strong data becoming available 2, 3. That interest reflects the continuing desire of our patients to seek alternatives to the standard drug or surgical therapies.

The success of UroLift® (Neotract, Pleasanton, CA, USA) in satisfying the rigour of the regulatory bodies (especially the Food and Drug Administration [FDA] in the USA and National Institute for Health and Care Excellence [NICE] in the UK) and the recent merger/acquisition of Neotract by Teleflex Inc. for a sum potentially exceeding 1 billion dollars, indicates the rewards available for a novel treatment with convincing data. Not surprisingly, this has stimulated innovators, so there is a veritable tsunami of new treatments approaching us. The rewards are certainly encouraging, but it is worth remembering that the difficulties and cost of reaching market and the point of sale are now enormous.

The TIND stent is implanted endoscopically and then gradually distends to cause three linear pressure necrosis effects within the prostatic urethra and bladder neck tissues, before it is removed at approximately 5–7 days by a second, minor and office‐based procedure.

However, this report is simply a repeat of the initial case series from 2015 4, just with follow‐up to 36 months. An initial report is legitimate in order to show primarily safety and with effectiveness as a secondary outcome measure. I see limited value in a follow‐up report of a device that has already been superseded by a second version, which is currently being assessed in the more rigorous studies that we, our patients, and regulators require.

Even so, there are some important messages and some inconsistencies. Porpiglia et al. 1 are, firstly, to be commended for successfully following their patients out to 3 years with essentially complete data sets. That is remarkable. Although the TIND seems safe, there was one serious complication (a prostatic abscess associated with arrhythmia, sepsis and hyperglycaemia, which required 10 days of inpatient care). About 10% of men restarted medical therapy, but are not ‘failures’, as failures are defined only as those requiring surgical treatment. The prostate size in this small cohort is also surprisingly small compared to the initial studies of other novel devices (29.5 vs 50 mL for UroLift in the initial report) 5. It is also surprising that even though all were on α‐blockers and a substantial proportion were taking 5α‐reductase inhibitors that there is no sexual or especially ejaculatory dysfunction in any of the 19 sexually active men before or after TIND implantation. They appear to have surprisingly resilient ejaculatory function and one wonders why or how? The population studied may therefore not be representative of men we meet in our clinics. Nevertheless, the safety and effectiveness of the original TIND stent do seem reasonable and many of us will await the definitive ‘pivotal’ randomised controlled studies of the successor device with great interest.

For the TIND to find a place in our range of treatments, we urologists, our patients, and regulators of healthcare, now need to see proper randomised controlled trials, preferably incorporating a sham arm and eventually comparisons with TURP. Ideally, the TIND should also be compared to UroLift and to steam injection (Rezūm®; NxThera, Inc., Maple Grove, MN, USA). But who will pay for these studies, even if the regulators insist on them? Funding the required studies is now a major financial challenge to any new device in development. Those studies cost more than we think. A survey of >200 MedTech companies in 2010 suggested device development costs up to 100 million dollars (the majority spent on FDA‐dependent or related activities) but for UroLift total development spend was nearly 240 million. Unfortunately, even innovative and potentially useful devices will struggle to overcome the double jeopardy of regulatory hurdles and obtaining the finance required to clear them. I wish the developers of TIND well and hope there is adequate funding. Today, developers need deep pockets to perform the proper studies correctly.

 

Tom McNicholas
Pinehill Hospital, Hitchin, Herts, UK

References

 

  • 1 Porpiglia F, Fiori C, Bertolo R et al. 3‐Year follow‐up of temporary implantable nitinol device implantation for the treatment of benign prostatic obstruction. BJU Int2018; 122: 106–12

 

  • 2 Roehrborn CG, Barkin J, Gange SN et al. Five year results of the prospective randomized controlled prostatic urethral L.I.F.T. study. Can J Urol 2017; 24: 8802–13

 

  • 3 McVary KT, Roehrborn CG. Three‐year outcomes of the prospective, randomized controlled Rezūm System study: convective radiofrequency thermal therapy for treatment of lower urinary tract symptoms due to benign prostatic hyperplasia. Urology 2018; 111: 1–9

 

  • 4 Porpiglia F, Fiori C, Bertolo R, Garrou D, Cattaneo G, Amparore D. Temporary implantable nitinol device (TIND): a novel, minimally invasive treatment for relief of lower urinary tract symptoms (LUTS) related to benign prostatic hyperplasia (BPH): feasibility, safety and functional results at 1 year of follow‐up. BJU Int 2015; 116: 278–87

 

  • 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 hyperplasia (BPH). BJU Int 2011; 108: 82–8

 

Residents’ Podcast: Follow‐up of TIND implantation for the treatment of benign prostatic obstruction

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Maria Uloko and Guilia Lane are Urology Residents at the University of Minnesota Hospital.

In this podcast they discuss the BJUI Article of the Week, 3‐Year follow‐up of temporary implantable nitinol device implantation for the treatment of benign prostatic obstruction
Special Guest: Mike Borofsky

 

3‐Year follow‐up of temporary implantable nitinol device implantation for the treatment of benign prostatic obstruction

 

Francesco Porpiglia , Cristian Fiori, Riccardo Bertolo, Andrea Giordano, Enrico Checcucci, Diletta Garrou, Giovanni Cattaneo, Stefano De Luca and Daniele Amparore

 

Division of Urology, Department of Oncology – School of Medicine, San Luigi Hospital, University of Turin, Orbassano (Turin), Italy

 

Read the full article

Abstract

Objectives

To report 3‐year follow‐up results of the first implantations with a temporary implantable nitinol device (TIND®; Medi‐Tate Ltd., Or Akiva, Israel) for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).

Patients and Methods

In all, 32 patients with LUTS were enrolled in this prospective study. The study was approved by the local Ethics Committee. Inclusion criteria were: age >50 years, International Prostate Symptom Score (IPSS) ≥10, peak urinary flow (Qmax) <12 mL/s, and prostate volume <60 mL. The TIND was implanted within the bladder neck and the prostatic urethra under light sedation, and removed 5 days later in an outpatient setting. Demographics, perioperative results, complications (according to Clavien–Dindo classification), functional results, and quality of life (QoL) were evaluated. Follow‐up assessments were made at 3 and 6 weeks, and 3, 6, 12, 24 and 36 months after the implantation. The Student’s t‐test, one‐way analysis of variance and Kruskal–Wallis tests were used for statistical analyses.

Results

At baseline, the mean (standard deviation, sd) patient age was 69.4 (8.2) years, prostate volume was 29.5 (7.4) mL, and Qmax was 7.6 (2.2) mL/s. The median (interquartile range, IQR) IPSS was 19 (14–23) and the QoL score was 3 (3–4). All the implantations were successful, with a mean total operative time of 5.8 min. No intraoperative complications were recorded. The change from baseline in IPSS, QoL score and Qmax was significant at every follow‐up time point. After 36 months of follow‐up, a 41% rise in Qmax was achieved (mean 10.1 mL/s), the median (IQR) IPSS was 12 (6–24) and the IPSS QoL was 2 (1–4). Four early complications (12.5%) were recorded, including one case of urinary retention (3.1%), one case of transient incontinence due to device displacement (3.1%), and two cases of infection (6.2%). No further complications were recorded during the 36‐month follow‐up.

Conclusions

The extended follow‐up period corroborated our previous findings and suggests that TIND implantation is safe, effective and well‐tolerated, for at least 36 months after treatment.

Read more articles of the week

 

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Article of the Month: The Metabolic Syndrome & the Prostate

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Every Month, the Editor-in-Chief selects an Article of the Month 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.

Association between metabolic syndrome and intravesical prostatic protrusion in patients with benign prostatic enlargement and lower urinary tract symptoms (MIPS Study)

Giorgio I. Russo*, Federica Regis*, Pietro Spatafora†, Jacopo Frizzi†, Daniele Urzı*, Sebastiano Cimino*, Sergio Serni†, Marco Carini†, Mauro Gacci† and Giuseppe Morgia*

 

*Urology Section, Department of Surgery, University of Catania, Catania, Italy, and †Department of Urology, University of Florence, Florence, Italy

 

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Abstract

Objective

To investigate the association between metabolic syndrome (MetS) and morphological features of benign prostatic enlargement (BPE), including total prostate volume (TPV), transitional zone volume (TZV) and intravesical prostatic protrusion (IPP).

Patients and Methods

Between January 2015 and January 2017, 224 consecutive men aged >50 years presenting with lower urinary tract symptoms (LUTS) suggestive of BPE were recruited to this multicentre cross‐sectional study. MetS was defined according to International Diabetes Federation criteria. Multivariate linear and logistic regression models were performed to verify factors associated with IPP, TZV and TPV.

Results

Patients with MetS were observed to have a significant increase in IPP (P < 0.01), TPV (P < 0.01) and TZV (P = 0.02). On linear regression analysis, adjusted for age and metabolic factors of MetS, we found that high‐density lipoprotein (HDL) cholesterol was negatively associated with IPP (r = −0.17), TPV (r = −0.19) and TZV (r = −0.17), while hypertension was positively associated with IPP (r = 0.16), TPV (r = 0.19) and TZV (r = 0.16). On multivariate logistic regression analysis adjusted for age and factors of MetS, hypertension (categorical; odds ratio [OR] 2.95), HDL cholesterol (OR 0.94) and triglycerides (OR 1.01) were independent predictors of TPV ≥ 40 mL. We also found that HDL cholesterol (OR 0.86), hypertension (OR 2.0) and waist circumference (OR 1.09) were significantly associated with TZV ≥ 20 mL. On age‐adjusted logistic regression analysis, MetS was significantly associated with IPP ≥ 10 mm (OR 34.0; P < 0.01), TZV ≥ 20 mL (OR 4.40; P < 0.01) and TPV ≥ 40 mL (OR 5.89; P = 0.03).

Conclusion

We found an association between MetS and BPE, demonstrating a relationship with IPP.

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Article of the Week: Impact of dutasteride/tamsulosin combination therapy on sexual function in men with LUTS secondary to BPH

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Every Week, the Editor-in-Chief selects an 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 month, it should be this one.

A prospective randomised placebo‐controlled study of the impact of dutasteride/tamsulosin combination therapy on sexual function domains in sexually active men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH)

 

Claus G. Roehrborn*, Michael J. Manyak†, Juan Manuel Palacios-Moreno‡, Timothy H. Wilson§, Erik P.M. Roos, Javier Cambronero Santos**, Dimitrios Karanastasis††, Janet Plastino‡‡, Francois Giuliano§§ and Raymond C. Rosen¶¶

 

*Department of Urology, University of Texas (UT) Southwestern Medical Center, Dallas, TX, USA, †GlaxoSmithKline (GSK), Washington, DC, USA, ‡GSK, Madrid, Spain, §PAREXEL International, Durham, NC, USA, Antonius Ziekenhuis Sneek, Sneek, The Netherlands, **Hospital Universitario Infanta Leonor, Madrid, Spain, ††Urologic Clinic, General Hospital of Athens ‘Elpis’, Athens, Greece, ‡‡GSK, Collegeville, PA,USA, §§Neuro-Urology R. Poincare Hospital AP-HP, Garches, UMR1179 Inserm-UVSQ-Paris Saclay University, Paris, France, France, and ¶¶New England Research Institutes,nWatertown, MA, USA

 

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Abstract

Objective

To prospectively assess the impact of the fixed‐dose combination (FDC) of the 5α‐reductase inhibitor (5ARI), dutasteride 0.5 mg and the α1‐adrenoceptor antagonist, tamsulosin 0.4 mg (DUT‐TAM FDC) therapy on sexual function domain scores in sexually active men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH), using the Men’s Sexual Health Questionnaire (MSHQ).

Patients and Methods

This European and Australian double‐blind, placebo‐controlled, parallel‐group study was conducted at 51 centres. Inclusion criteria: age ≥50 years, International Prostate Symptom Score ≥12, prostate volume ≥30 cc, prostate‐specific antigen 1.5–10 ng/mL. Patients were randomised 1:1 to DUT‐TAM FDC therapy or placebo for 12 months. The change from baseline to Month 12 on the total MSHQ (primary endpoint) and MSHQ erection, ejaculation and satisfaction domains (secondary outcome) was assessed, using a mixed model repeated measures analysis. Safety was evaluated.

Results

The intention‐to‐treat population included 489 patients (243 DUT‐TAM FDC therapy; 246 placebo). A significant decrease (worsening) was observed with DUT‐TAM FDC therapy versus placebo on the total MSHQ score (−8.7 vs −0.7; standard error [se]: 0.81, 0.78; P < 0.001), and the ejaculation (−7.5 vs −0.6; se: 0.56, 0.55; P < 0.001) and satisfaction (−0.6 vs +0.3; se: 0.3, 0.29, P = 0.047) domains, but not the erection domain (−1.0 vs −0.5; se: 0.19, 0.19, P = 0.091).

Conclusion

This is the first domain‐specific quantitative evaluation of DUT‐TAM FDC therapy on sexual function in men with LUTS secondary to BPH. The observed changes in the MSHQ with DUT‐TAM FDC therapy were mainly driven by changes in the ejaculation domain. These findings will help give context to erectile and ejaculatory dysfunction AEs reported spontaneously in earlier 5ARI studies.

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Royal Society of Medicine: Key issues in Endourology

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The RSM section of Urology #RSMUrology hosted a day on the Key issues in Endourology on 20th October. This was the first meeting of the academic year under President Roland Morley. Sri Sriprisad put together a complete endourology day with key subject areas of  “PCNL and stones”, “upper tract TCC” and “BPH and retention”. Speakers from India, America and Spain provided expert opinions from around the globe.

The day started with the evolution of stone and urological laparoscopic surgery. Showing an insight into the challenges with the initial introduction of laparoscopic urological surgery. In order to allow surgeons the chance to discuss their experiences and troubleshoot and develop surgical techniques the SLUG forum (southern laparoscopic urology group) was created, which is still running today in the annual AUA meeting.

PCNL techniques were the subject for several debate lectures. Access for PCNL tracts was debated by Dr Janak Desai, visiting from Samved Urology hospital in India, arguing for fluoroscopic puncture with over 10,000 cases to date! Jonathan Glass, from Guy’s and St. Thomas’ Hospital, spoke for the prone position for the majority of PCNL, but selecting the supine position in 5-10% of cases depending on the anatomy and stone position. Dr Desai also spoke on ultra-mini PCNL, which he advocates using to treat solitary kidney stones under 2 cm in preference to flexible ureteroscopy.

The future of ESWL was debated and the audience voted that it is still “alive and clicking” by a narrow margin. However, although up to 80% clearance rates are quoted for upper pole stones less than 2 cm, the problem is that results of treatment are varied and unpredictable, and real-life success rates are far inferior. The variation in results may in part be due to the fact that there are no formal training courses for specialist radiographers nor SAC requirements for specialist registrars. Professor Sam McClinton presented on clinical research in stone disease with results from the TISU trial on primary ESWL vs. ureteroscopy for ureteric stones due out next year. The results will be fascinating and may help to decide if ESWL has a future in the UK.

Professor Margaret Pearle, visiting from the University of Texas Southwestern Medical Centre, explained the importance of treating residual fragments. With data showing that 20 – 36% of >2 mm residual stones after ureteroscopy required repeat surgery within 1 year. In a thought provoking lecture, she presented data showing that ureteroscopy may not be as good as we think and when critically examined, true stone-free rates maybe no better than ESWL. Maybe miniaturised PCNL is the way forward after all?

The follow up of small kidney stones is an uncertain area with very little written in either the EAU or AUA guidelines. Data from a meta-analysis by Ghani et al. shows that for every year of follow up on small kidney stones 7% may pass, 14% grow and 7% will require intervention. However, it is not possible in most health systems to follow everyone up forever and Mr Bultitude advocated increasing discharge rates from stone clinics to primary care after an agreed time of stability, allowing more on the complex and metabolic stone formers.Figure 1- Stone follow up algorithm

The expert stone panel then debated several challenging cases including “the encrusted stent”, stones in a pelvic kidney or calyceal diverticulum. These cases certainly are a challenge and require an individualized approach usually with multi-modality treatments.

Figure 2 – Stone expert panel

Upper tract urological biopsies are notoriously inaccurate, with only 15% of standard biopsies quantifiable histologically. Low grade tumours, are potentially suitable for endoscopic management with laser ablation. Dr Alberto Breda, from the urology department of Fundacio Puigvert Hospital in Spain, presented a novel solution for the future. This promising new technology uses confocal endomicroscopy to grade upper tract urological cancer. Initial results show 90% accuracy in diagnosing low grade tumours, which could then be safely managed endoscopically avoiding nephron-ureterectomy for some patients.

 

Figure 3 – Confocal endomicroscopy for upper tract malignancy

In the final session, a debate on BPH treatment, the audience preferred the bipolar resection technique for treating “the 60 year old with retention, with a 90 gram prostate and on rivaroxaban”, although HOLEP came a close second, with that talk giving the quote of the day “I spend more time with the morcellator than the wife.”

Figure 4 – Bipolar TURP wins the day

 

Nishant Bedi

ST4 Specialist urology registrar

 

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