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Video: Posterior Muscolofascial Reconstruction after RP

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Posterior musculofascial reconstruction after radical prostatectomy: an updated systematic review and a meta-analysis

Angelica A.C. Grasso*, Francesco A. Mistretta*, Marco Sandri†, Gabriele Cozzi*, Elisa De Lorenzis*, Marco Rosso*, Giancarlo Albo*, Franco Palmisano*, Alex Mottrie‡, Alexander Haese§, Markus Graefen§, Rafael Coelho, Vipul R. Patel¶ and Bernardo Rocco*

 

*Department of Urology, Fondazione IRCCS Ca’ Granda-Ospedale Maggiore Policlinico, University of Milan, Milan, Italy, †DMS StatLab, Data Methods and Systems Statistical Laboratory, University of Brescia, Brescia, Italy, ‡OLV Robotic Surgery Institute, Aalst, Belgium, §Martini Clinic Prostate Cancer Center, University Clinic Eppendorf, Hamburg, Germany, and Global Robotics Institute, Florida Hospital-Celebration Health Celebration, University of Central Florida School of Medicine, Orlando, FL, USA

 

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To evaluate the influence of posterior musculofascial plate reconstruction (PR) on early return of continence after radical prostatectomy (RP); an updated systematic review of the literature. A systematic review of the literature was performed in June 2015, following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement and searching Medline, Embase, Scopus and Web of Science databases. We searched the terms posterior reconstruction prostatectomy, double layer anastomosis prostatectomy across the ‘Title’ and ‘Abstract’ fields of the records, with the following limits: humans, gender (male), and language (English). The authors reviewed the records to identify studies comparing cohorts of patients who underwent RP with or without restoration of the posterior aspect of the rhabdosphincter. A meta-analysis of the risk ratios estimated using data from the selected studies was performed. In all, 21 studies were identified, including three randomised controlled trials. The overall analysis of comparative studies showed that PR improved early continence recovery at 3–7, 30, and 90 days after catheter removal, while the continence rate at 180 days was statistically but not clinically affected. Statistically significantly lower anastomotic leakage rates were described after PR. There were no significant differences for positive surgical margins rates or for complications such as acute urinary retention and bladder neck stricture. The analysis confirms the benefits at 30 days after catheter removal already discussed in the review published in 2012, but also shows a significant advantage in terms of urinary continence recovery in the first 90 days. A multicentre prospective randomised controlled trial is currently being conducted in several institutions around the world to better assess the effectiveness of PR in facilitating an earlier recovery of postoperative urinary continence.

 

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Article of the Week: Complications following artificial urinary sphincter placement after RP and EBRT

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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 week, it should be this one.

Complications following artificial urinary sphincter placement after radical prostatectomy and radiotherapy: A meta-analysis

Anthony S. Bates, Richard M. Martin* and Tim R. Terry

Department of Urology, Leicester General Hospital, University Hospitals of Leicester NHS Trust, Leicester, and *School of Social and Community Medicine, University of Bristol, Bristol, UK

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OBJECTIVE

To conduct a systematic review and meta-analysis of artificial urinary sphincter (AUS) placement after radical prostatectomy (RP) and external beam radiotherapy (EBRT).

PATIENTS AND METHODS

There were 1 886 patients available for analysis of surgical revision outcomes and 949 for persistent urinary incontinence (UI) outcomes from 15 and 11 studies, respectively. The mean age (sd) was 66.9 (1.4) years and the number of patients per study was 126.6 (41.7). The mean (sd, range) follow-up was 36.7 (3.9, 18–68) months. A systematic database search was conducted using keywords, according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Published series of AUS implantations were retrieved, according to the inclusion criteria. The Newcastle–Ottawa Score was used to ascertain the quality of evidence for each study. Surgical results from each case series were extracted. Data were analysed using CMA® statistical software.

RESULTS

AUS revision was higher in RP + EBRT vs RP alone, with a random effects risk ratio of 1.56 (95% confidence interval [CI] 1.02–2.72; P <0.050; I2 = 82.0%) and a risk difference of 16.0% (95% CI 2.05–36.01; P < 0.080). Infection/erosion contributed to the majority of surgical revision risk compared with urethral atrophy (P = 0.020). Persistent UI after implantation was greater in patients treated with EBRT (P <0.001).

CONCLUSIONS

Men receiving RP + EBRT appear at increased risk of infection/erosion and urethral atrophy, resulting in a greater risk of surgical revision compared with RP alone. Persistent UI is more common with RP + EBRT

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Editorial: Post-prostatectomy incontinence in the irradiated patient: more than just a drop in the ocean

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Improved early detection of prostate cancer has led to an increased incidence of this disease, and an increase in the number of patients undergoing radical prostatectomy (RP). The rate of post-prostatectomy incontinence (PPI) is difficult to determine because of the varying definitions of incontinence, but approximately one in five men require the use of pads in the long term after RP. Incontinence has a significant negative impact on quality of life, and remains many men’s greatest fear, especially for the one in four who present at the age of <65 years. While significant advancements have been made in prostate cancer treatment, strong evidence for the optimum management of PPI remains lacking. Most guidelines are based on grade B or C recommendation and many questions about its surgical management remain unanswered.

The artificial urinary sphincter (AUS) has stood the test of time and has long been considered the ‘gold standard’ treatment for PPI, especially for those with moderate to severe incontinence. The quoted success rates achieved with this device vary from study to study based on the varying definition of ‘dry’. The use of radiotherapy (RT) after prostatectomy is generally considered to have a negative impact on its efficacy and revision rate, although some data have been conflicting. In this month’s BJUI, Bates et al. [1] present a timely and well-structured systematic review and meta-analysis of AUS placement after RP and RT. By analysing pooled results, the authors set out to clarify the effect of RT on AUS efficacy and outcomes. In total, 1886 patients from 15 studies published between 1989 and 2014 were included in the meta-analysis, including 14 studies assessing surgical revision and 11 looking at persistent urinary incontinence. No randomized controlled trials were available for analysis. Retrospective reporting and a lack of standardized postoperative validated assessments were a weakness of individual studies, and efforts to limit the effects of study heterogeneity and risk of bias were made using statistical models. The revision rate after a mean follow-up of 38.4 months was significantly higher in irradiated vs. non-irradiated men (mean 37.3 vs 19.8%; P < 0.007); the risk ratio was 1.56 and number needed to harm was 4 (i.e. one surgical revision for every four AUS devices implanted in irradiated men). Infection/erosion and urethral atrophy accounted for approximately half and one-third of all revisions respectively. Persistent urinary incontinence was also more than twice as likely in irradiated vs non-irradiated men (29.5 vs 12.1%; P = 0.003; risk ratio 2.08, number needed to harm 9).

This study highlights the significant negative impact of RT after RP on functional outcomes and its treatment. This is particularly important considering that approximately one-third of patients will require adjuvant or salvage radiotherapy at some stage after RP. The development of incontinence after RT is primarily attributable to the negative effect of radiation on bladder and urethral tissue. Unlike outcomes with regard to erectile function, the type of primary surgery performed (open vs robotic) does not appear to have any significant impact on PPI [2]. Timing of RT also does not seem to affect function, with similar rates of incontinence reported for early (<6 months after RP) vs late (>6 months after RP) irradiation reported 3 years after RT (24.5 vs 23.3%, respectively; P = 0.79) [3].

New devices, such as the male sling, have increased the options for PPI treatment. Male slings have achieved popularity because of their safety, relative ease of insertion and patients’ strong desire to void naturally without fiddling with pumps. Kumar et al. [4] reported that one in four men who were recommended an AUS as the best option by their surgeon chose a sling; 92% who were offered either also opted against the gold standard AUS. Slings, however, have not fared well in patients with severe incontinence or those who have undergone RT. Pooled analysis of the AdVance® sling reported ‘success’ rates of 56 and 54%, respectively, in these scenarios, compared with a mean overall ‘success’ rate of 75% [5]. Reported success, however, does not equate to being ‘dry’, as reported in many AUS studies, and this lack of uniformity in describing outcomes prevents adequate clarity when comparing different devices. Despite the lower success rate after RT, slings, unlike the AUS, do not appear to have any additional complications in this setting [1, 6], and sling failure does not appear to prejudice subsequent AUS placement [7].

To date, no randomized controlled trial has directly compared efficacy of the newer slings with the AUS. Well-designed trials, with standardized protocols and uniform long-term assessments of outcome, including complications and quality of life, are required to clarify their place in managing PPI. Current randomized controlled trials are evaluating these devices prospectively, and will provide much needed level 1 evidence in this field. The most interesting of these is the MASTER trial (Male synthetic sling vs Artificial urinary Sphincter Trial). This multicentre UK randomized controlled trial is for men with incontinence after prostate surgery for cancer or benign disease [8]. Patients of any age, with any level of incontinence are eligible, and previous RT is not an exclusion criterion. The trial aims to randomize 360 men and will also follow up 360 non-randomized men, and runs until 2019. This trial will help clarify the relative benefits of the devices by incontinence severity. It will also provide some prospective data on the effect of RT on outcomes, although the 2-year follow-up will be too short to evaluate this fully.

The question remains regarding which strategy is the best for post-prostatectomy irradiated patients. Until the results of good quality trials are available, the jury is out. The AUS remains the gold standard in this setting, for now. For patients with mild to moderate incontinence, the sling is an option, and offers some advantages, but offers a lower overall chance of becoming pad free. Patients must be carefully counselled about the risk/benefit of this approach compared with an AUS. Results of the MASTER trial will help better define management of this subgroup. For moderate to severe incontinence, the AUS is the gold standard, albeit with an increased risk of failure and revision. The present meta-analysis arms the clinician with much needed data to quantify the relative risk of complications and adverse outcomes in this setting, and will allow better counselling and management of patient’s expectations.

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Majid Shabbir

Department of Urology, Guy’s Hospital, London, UK

References

1 Bates A, Martin R, Terry T. Complications following artificial urinary sphincter placement after radical prostatectomy and radiotherapy: a metaanalysis. BJU Int 2015; 116: 623–33

2 Haglind E, Carlsson S, Stranne J et al. Urinary incontinence and erectile dysfunction after robotic versus open radical prostatectomy: a prospective, controlled, nonrandomised trial. Eur Urol 2015. doi: 10.1016/j.eururo. 2015.02.029. [Epub ahead of print]

3 Sowerby RJ, Gani J, Yim H. Long-term complications in men who have early or late radiotherapy after radical prostatectomy. Can Urol Assoc J 2014; 8: 253–8.

4 Kumar A, Litt ER, Ballert KN, Nitti VW. Artificial urinary sphincter versus male sling for post-prostatectomy incontinence-what do patients choose? J Urol 2009; 181: 1231–5.

5 Van Bruwaene S, Van der Aa F, De Ridder D. Review: the use of sling versus sphincter in post-prostatectomy urinary incontinence. BJU Int 2015; 116: 330–42

6 Zuckerman JM, Tisdale B, McCammon K. AdVance male sling in irradiated patients with stress urinary incontinence. Can J Urol 2011; 18: 6013–7.

7 Lentz AC, Peterson AC, Webster GD. Outcomes following artificial sphincter implantation after prior unsuccessful male sling. J Urol 2012; 187: 2149–53.

8 Abrams P. Male synthetic sling versus Artificial urinary Sphincter Trial for men with urodynamic stress incontinence after prostate surgery: Evaluation by Randomised controlled trial (MASTER), 2014. Available at: www.controlled-trials.com/ISRCTN49212975/MASTER. Accessed May 2015

 

Video: Complications following AUS placement after RP and radiotherapy

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Complications following artificial urinary sphincter placement after radical prostatectomy and radiotherapy: a meta-analysis

Anthony S. Bates1,*, Richard M. Martin2 and Tim R. Terry1

1Department of Urology, Leicester General Hospital, University Hospitals of Leicester NHS Trust, Leicester, UK 2School of Social and Community Medicine, University of Bristol, Bristol, UK

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Objective

To conduct a systematic review and meta-analysis of artificial urinary sphincter (AUS) placement after radical prostatectomy (RP) and external beam radiotherapy (EBRT).

Patients and Methods

There were 1 886 patients available for analysis of surgical revision outcomes and 949 for persistent urinary incontinence (UI) outcomes from 15 and 11 studies, respectively. The mean age (sd) was 66.9 (1.4) years and the number of patients per study was 126.6 (41.7). The mean (sd, range) follow-up was 36.7 (3.9, 18–68) months. A systematic database search was conducted using keywords, according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Published series of AUS implantations were retrieved, according to the inclusion criteria. The Newcastle–Ottawa Score was used to ascertain the quality of evidence for each study. Surgical results from each case series were extracted. Data were analysed using CMA® statistical software.

Results

AUS revision was higher in RP + EBRT vs RP alone, with a random effects risk ratio of 1.56 (95% confidence interval [CI] 1.02–2.72; P < 0.050; I2 = 82.0%) and a risk difference of 16.0% (95% CI 2.05–36.01; P < 0.080). Infection/erosion contributed to the majority of surgical revision risk compared with urethral atrophy (P = 0.020). Persistent UI after implantation was greater in patients treated with EBRT (P < 0.001).

Conclusions

Men receiving RP + EBRT appear at increased risk of infection/erosion and urethral atrophy, resulting in a greater risk of surgical revision compared with RP alone. Persistent UI is more common with RP + EBRT.

 

Guideline of guidelines: urinary incontinence

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Urinary Incontinence Guideliens

 

Abstract

The objective of the article is to review key guidelines on the management of urinary incontinence (UI) to guide clinical management in a practical way. Guidelines produced by the European Association of Urology (updated in 2014), the Canadian Urological Association (updated in 2012), the International Consultation on Incontinence (updated in 2012), and the National Collaborating Centre for Women’s and Children’s Health (updated in 2013) were examined and their recommendations compared. In addition, specialised guidelines produced by the collaboration between the American Urological Association and the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction on overactive bladder and the use of urodynamics were reviewed. The Appraisal of Guidelines for Research and Evaluation II (AGREE) instrument was used to evaluate the quality of these guidelines. There is general agreement between the groups on the recommended initial evaluation and the use of conservative therapies for first-line treatment, with a limited role for imaging or invasive testing in the uncomplicated patient. These groups have greater variability in their recommendations for invasive procedures; however, generally the mid-urethral sling is recommended for uncomplicated stress UI, with different recommendations on the approach, as well as the comparability to other treatments, such as the autologous fascial sling. This ‘Guideline of Guidelines’ provides a summary of the salient similarities and differences between prominent groups on the management of UI.

Urinary Incontinence key points

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Conjoint USANZ and UGSA Guidelines on the management of adult non-neurogenic overactive bladder

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Guidelines

Abstract

Due to the myriad of treatment options available and the potential increase in the number of patients afflicted with overactive bladder (OAB) who will require treatment, the Female Urology Special Advisory Group (FUSAG) of the Urological Society of Australia and New Zealand (USANZ), in conjunction with the Urogynaecological Society of Australasia (UGSA), see the need to move forward and set up management guidelines for physicians who may encounter or have a special interest in the treatment of this condition. These guidelines, by utilising and recommending evidence-based data, will hopefully assist in the diagnosis, clinical assessment, and optimisation of treatment efficacy. They are divided into three sections: Diagnosis and Clinical Assessment, Conservative Management, and Surgical Management. These guidelines will also bring Australia and New Zealand in line with other regions of the world where guidelines have been established, such as the American Urological Association, European Association of Urology, International Consultation on Incontinence, and the National Institute for Health and Care Excellence guidelines of the UK.

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Article of the week: The changing face of urinary continence surgery 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 John Withington and Arun Sahai discussing their paper.

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

The changing face of urinary continence surgery in England: a perspective from the Hospital Episode Statistics database

John Withington, Sadaf Hirji and Arun Sahai

Guy’s and St Thomas’ NHS Hospitals’Trust, King’s College London, London, UK

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OBJECTIVE

To quantify changes in surgical practice in the treatment of stress urinary incontinence (SUI), urge urinary incontinence (UUI) and post-prostatectomy stress incontinence (PPI) in England, using the Hospital Episode Statistics (HES) database.

PATIENTS AND METHODS

We used public domain information from the HES database, an administrative dataset recording all hospital admissions and procedures in England, to find evidence of change in the use of various surgical procedures for urinary incontinence from 2000 to 2012.

RESULTS

For the treatment of SUI, a general increase in the use of synthetic mid-urethral tapes, such as tension-free vaginal tape (TVTO) and transobturator tape (TOT), was observed, while there was a significant decrease in colposuspension procedures over the same period. The number of procedures to remove TVT and TOT has also increased in recent years. In the treatment of overactive bladder and UUI, there has been a significant increase in the use of botulinum toxin A and neuromodulation in recent years. This coincided with a steady decline in the recorded use of clam ileocystoplasty. A steady increase was observed in the insertion of artificial urinary sphincter (AUS) devices in men, related to PPI.

CONCLUSIONS

Mid-urethral synthetic tapes now represent the mainstream treatment of SUI in women, but tape-related complications have led to an increase in procedures to remove these devices. The uptake of botulinum toxin A and sacral neuromodulation has led to fewer clam ileocystoplasty procedures being performed. The steady increase in insertions of AUSs in men is unsurprising and reflects the widespread uptake of radical prostatectomy in recent years. There are limitations to results sourced from the HES database, with potential inaccuracy of coding; however, these data support the trends observed by experts in this field.

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Editorial: Routine data expose a need for change

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Withington et al. [1], in their analysis of changes in stress urinary incontinence (SUI) surgery in England, have tapped in to a rich seam of information which, as well as holding the promise of much more, also highlights a need for changed thinking about services and training. They have produced an excellent review of the use of Hospital Episode Statistics (HES) data to establish a pattern of changing surgical practice for the treatment of urinary incontinence in England. They rightly point out the great potential of using patient-specific linked data to explore other relationships between predictors and outcome. Widespread use of powerful data of this sort could, theoretically at least, help to answer research questions, as well as to plan service design and resource allocation.

The use of routine data by the NHS is a hot topic in the UK at present. An England wide database, Care.data, has been developed that plans to link anonymised routine data, automatically drawn from community care, hospital statistics, public health and social care databases. Whilst debate rages about the confidentiality issues, and conspiracy theories abound, some strident voices promote a vision of how such a databank will be used to address big health questions and to identify relationships between social conditions, healthcare and outcomes, which have not previously been possible. Similar projects exist in Wales and Scotland enjoying the acronyms of SAIL (Secure Anonymised Information Linkage) and SPIRE (The Scottish Primary Care Information Resource), and Northern Ireland also has plans in progress. These systems do differ subtly in detail but not in aspiration [2].

The authors’ findings confirm that lesser invasive procedures now dominate the treatment of SUI in women, and that the use of Botulinum toxin A for treating refractory urgency incontinence, despite the absence until recently of a license for its use, has become commonplace. Whilst demand for SUI surgery may have levelled off, following something of a surge in recent years, the demand for Botulinum toxin A treatment inevitably increases as patients become locked in to long-term retreatment programmes. With these numbers it should be possible for a hospital serving a population of, say, 250 000 to perform at least 40–50 of each procedure per annum. This is probably enough to sustain a routine service, consistent with recommendations from the National Institute for Health and Clinical Excellence (NICE), which described how surgeons should seek to maintain expertise through, amongst other things, having an adequate caseload [3].

Sacral neuromodulation (SNS), artificial sphincter, colposuspension, tape removal and augmentation cystoplasty are procedures that occupy the complex end of a range of surgical options for incontinence. These are patients who have often failed other treatments, defy easy categorisation, and are performed in relatively small numbers. SNS has not been adopted in the UK, as widely as might have been anticipated following NICE guidance in 2006, which strongly recommended its implementation – perhaps because of local difficulties in commissioning a procedure with such high capital costs. The low figures for all these procedures strengthen the argument to focus complex work into expert centres, where adequate numbers can be maintained and the next generation of specialists can be effectively trained.

Those who commission or plan service delivery, and those who design training programmes, need to take heed of this evidence. The nature of female and urodynamic urology has changed over recent years, now being characterised by 95% very routine procedures and 5% complex difficult cases. But if we centralise the 5% of complex work and leave those working in more peripheral hospitals able to offer only mid-urethral slings and Botulinum toxin A, then we have to reconsider the basis of specialist training. There is no point training a person to high levels of competence in complex procedures that they will never use in senior practice. The UK Continence Society is currently developing a set of minimum standards for service delivery and training, which will take this information into account.

The evidence presented by Withington et al. [1] is specific to England and it remains unclear how much these trends can be extrapolated to the UK nations with devolved healthcare, or indeed to other countries. However, Withington et al. [1] must be congratulated for highlighting both the power of routine data in clinical research, and specifically for identifying the dramatic changes in surgical practice of incontinence, which require an adaptive response from both the NHS and our specialist organisations.

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Malcolm Lucas
Department of Urology, Morriston Hospital, Swansea, UK

References

  1. Withington J, Hirji S, Sahai A. The changing face of urinary continence surgery in England: a perspective from the hospital episode statistics database. BJU Int 2014; 114: 268–277
  3. National Institute for Health and Clinical Excellence. September 2013. Urinary incontinence: the management of urinary incontinence in women. Clinical guidelines CG171. Available at: https://guidance.nice.org.uk/CG171. Accessed April 2014

 

Video: Urinary continence surgery in England

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The changing face of urinary continence surgery in England: a perspective from the Hospital Episode Statistics database

John Withington, Sadaf Hirji and Arun Sahai

Guy’s and St Thomas’ NHS Hospitals’Trust, King’s College London, London, UK

Read the full article
OBJECTIVE

To quantify changes in surgical practice in the treatment of stress urinary incontinence (SUI), urge urinary incontinence (UUI) and post-prostatectomy stress incontinence (PPI) in England, using the Hospital Episode Statistics (HES) database.

PATIENTS AND METHODS

We used public domain information from the HES database, an administrative dataset recording all hospital admissions and procedures in England, to find evidence of change in the use of various surgical procedures for urinary incontinence from 2000 to 2012.

RESULTS

For the treatment of SUI, a general increase in the use of synthetic mid-urethral tapes, such as tension-free vaginal tape (TVTO) and transobturator tape (TOT), was observed, while there was a significant decrease in colposuspension procedures over the same period. The number of procedures to remove TVT and TOT has also increased in recent years. In the treatment of overactive bladder and UUI, there has been a significant increase in the use of botulinum toxin A and neuromodulation in recent years. This coincided with a steady decline in the recorded use of clam ileocystoplasty. A steady increase was observed in the insertion of artificial urinary sphincter (AUS) devices in men, related to PPI.

CONCLUSIONS

Mid-urethral synthetic tapes now represent the mainstream treatment of SUI in women, but tape-related complications have led to an increase in procedures to remove these devices. The uptake of botulinum toxin A and sacral neuromodulation has led to fewer clam ileocystoplasty procedures being performed. The steady increase in insertions of AUSs in men is unsurprising and reflects the widespread uptake of radical prostatectomy in recent years. There are limitations to results sourced from the HES database, with potential inaccuracy of coding; however, these data support the trends observed by experts in this field.

Read more articles of the week

Article of the month – Good vibrations: better erectile function with penile vibratory stimulation

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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 prominent members 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. Fode discussing his paper.

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

Penile vibratory stimulation in the recovery of urinary continence and erectile function after nerve-sparing radical prostatectomy: a randomized, controlled trial

Mikkel Fode*, Michael Borre†, Dana A. Ohl‡, Jonas Lichtbach§ and Jens Sønksen*

*Department of Urology, Herlev University Hospital, Herlev, †Department of Urology, Aarhus University Hospital, Aarhus, Denmark, ‡Department of Urology, University of Michigan, Ann Arbor, MI, USA, and §Department of Physiotherapy, Herlev University Hospital, Herlev, Denmark

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OBJECTIVE

• To examine the effect of penile vibratory stimulation (PVS) in the preservation and restoration of erectile function and urinary continence in conjunction with nerve-sparing radical prostatectomy (RP).

PATIENTS AND METHODS

• The present study was conducted between July 2010 and March 2013 as a randomized prospective trial at two university hospitals which we already determined with the physiotherapy system with the professional and affordable physiotherapy merrylands  has to offer for the trials. Eligible participants were continent men with an International Index of Erectile Function-5 (IIEF-5) score of at least 18, scheduled to undergo nerve-sparing RP.

• Patients were randomized to a PVS group or a control group. Patients in the PVS group were instructed in using a PVS device (FERTI CARE® vibrator).

• Stimulation was performed at the frenulum once daily by the patients in their own homes for at least 1 week before surgery. After catheter removal, daily PVS was re-initiated for a period of 6 weeks.

• Participants were evaluated at 3, 6 and 12 months after surgery with the IIEF-5 questionnaire and questions regarding urinary bother. Patients using up to one pad daily for security reasons only were considered continent. The study was registered at https://clinicaltrials.gov/ (NCT01067261).

RESULTS

• Data from 68 patients were available for analyses (30 patients randomized to PVS and 38 patients randomized to the control group).

• The IIEF-5 score was highest in the PVS group at all time points after surgery with a median score of 18 vs 7.5 in the control group at 12 months (P = 0.09), but the difference only reached borderline significance.

• At 12 months, 16/30 (53%) patients in the PVS group had reached an IIEF-5 score of at least 18, while this was the case for 12/38 (32%) patients in the control group (P = 0.07).

• There were no significant differences in the proportions of continent patients between groups at 3, 6 or 12 months. At 12 months 90% of the PVS patients were continent, while 94.7% of the control patients were continent (P = 0.46).

CONCLUSION

• The present study did not document a significant effect of PVS. However, the method proved to be acceptable for most patients and there was a trend towards better erectile function with PVS. More studies are needed to explore this possible effect further.

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