Tag Archive for: urinary incontinence

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Article of the week: Effectiveness of a longer urethral stump to prevent urinary incontinence after radical prostatectomy

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 both a video and a podcast discussing the paper.

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

Investigating the mechanism underlying urinary continence recovery after radical prostatectomy: effectiveness of a longer urethral stump to prevent urinary incontinence

Yoshifumi Kadono*, Takahiro Nohara*, Shohei Kawaguchi*, Renato Naito*, Satoko Urata*, Kazufumi Nakashima*, Masashi Iijima*, Kazuyoshi Shigehara*, Kouji Izumi*, Toshifumi Gabata† and Atsushi Mizokami*

*Department of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medical Science, Kanazawa, Japan; †Department of Radiology, Kanazawa University School of Medicine, 13‐1 Takara‐machi, Kanazawa, Ishikawa 920‐8640, Japan

Abstract

Objective

To assess the chronological changes in urinary incontinence and urethral function before and after radical prostatectomy (RP), and to compare the findings of pelvic magnetic resonance imaging (MRI) before and after RP to evaluate the anatomical changes.

Patients and Methods

In total, 185 patients were evaluated with regard to the position of the distal end of the membranous urethra (DMU) on a mid‐sagittal MRI slice and urethral sphincter function using the urethral pressure profilometry. The patients also underwent an abdominal leak point pressure test before RP and at 10 days and 12 months after RP. The results were then compared with the chronological changes in urinary incontinence.

Fig. 1 Intraoperative view of the apex of the prostate transection line between the urethra and prostate at (A) the normal and (B) long urethral stump positions.

Results

The MRI results showed that the DMU shifted proximally to an average distance of 4 mm at 10 days after RP and returned to the preoperative position at 12 months after RP. Urethral sphincter function also worsened 10 days after RP, with recovery after 12 months. The residual length of the urethral stump and urinary incontinence were significantly associated with the migration length of the DMU at 10 days after RP. The residual length of the urethral stump was a significant predictor of urinary incontinence after RP.

Conclusion

This is the first study to elucidate that the slight vertical repositioning of the membranous urethra after RP causes chronological changes in urinary incontinence. A long urethral residual stump reduces urinary incontinence after RP.

 

Article of the Week: TVT for treatment of pure urodynamic SUI

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.

Tension‐free vaginal tape for treatment of pure urodynamic stress urinary incontinence: efficacy and adverse effects at 17‐year follow‐up

Andrea Braga* , Giorgio Caccia*, Paola Sorice, Simona CantaluppiAnna Chiara Coluccia, Maria Carmela Di Dedda, Luca Regusci*, Fabio GhezziStefano Uccella§ and Maurizio Serati

 

*Department of Obstetrics and Gynecology, EOC Beata Vergine Hospital, Mendrisio, Switzerland, Department of Obstetrics and Gynecology, G. Fornaroli Hospital, Magenta, Italy, Department of Obstetrics and Gynecology, University of Insubria, Varese, Italy, and §Department of Woman and Child Health, Fondazione Policlinico Gemelli, Rome, Italy

 

Abstract

Objective

To assess the efficacy and safety of retropubic tension‐free vaginal tape (TVT) 17 years after implantation for the treatment of female pure stress urinary incontinence (SUI).

Patients and Methods

A prospective study was conducted in two urogynaecological units in two countries. All consecutive women with urodynamically proven pure SUI treated by TVT were included. Patients with mixed incontinence and/or anatomical evidence of pelvic organ prolapse were excluded. Data regarding subjective outcomes (International Consultation on Incontinence Questionnaire–Short Form, Patient Global Impression of Improvement, and patient satisfaction scores), objective cure (stress test) rates, and adverse events were collected during follow‐up. Univariable analysis was performed to investigate outcomes.

Results

A total of 52 women underwent TVT implantation. At 17‐year follow‐up, 46 women (88.4%) were available for the evaluation. We did not find any significant change in surgical outcomes during this time. At 17 years after surgery, 41 of 46 women (89.1%) declared themselves cured (P = 0.98). Similarly, at 17‐year evaluation, 42 of 46 women (91.4%) were objectively cured. No significant deterioration in objective cure rates was observed over time (P for trend 0.50). The univariate analysis did not find any risk factor statistically associated with the recurrence of SUI. Of the 46 women, 15 (32.6%) reported the onset of de novo overactive bladder at 17‐year follow‐up. No other late complications were reported.

Conclusions

The 17‐year results of this study showed that TVT is a highly effective and safe option for the treatment of SUI.

 

Comments are now closed for this article

Editorial: Can we still recommend tension‐free vaginal tape for long‐term safety and efficacy?

Traditional retropubic tension‐free vaginal tape (TVT) has been in widespread use for over 20 years. It has been estimated that 10 million women worldwide have received mid‐urethral tapes, and that at least half of these have been traditional retropubic TVTs. So, why have TVTs suddenly fallen into disrepute? Surely, so many women and their healthcare advisors can’t all be wrong? With this in mind, Braga et al. [1] are to be congratulated on their study in this issue of BJUI, in which they evaluate the efficacy and adverse effects of TVT for treatment of pure urodynamic stress urinary incontinence (SUI), with a 17‐year follow‐up.

Women’s reproductive health has been very well established compared to decades ago. Nowadays, women have options and opportunity to take care of themselves. After pregnancy, some women opt to tighten to vaginal walls. You can read more on that topic on vtightensafely.com. Reasons may vary for doing so, but the point is we’ve come a long way.

Whilst there have been other publications detailing relatively long‐term follow‐up of this procedure, as referenced in Braga et al. in their paper, the only study reported to date with a 17‐year follow‐up is that by Nillson et al. [2], who are from the three centres in Scandinavia where the mid‐urethral retropubic tape procedures were originally developed and undertaken. In the present study from Italy and Switzerland, however, Braga et al. have managed to follow up 46 out of 52 (88.4%) women who had a traditional TVT inserted between 1998 and 2000 [1]. The remaining patients were lost to follow‐up or had died in the intervening period. The patients were assessed using both subjective and objective outcome measures. At 17 years, 41 out of 46 patients (89.1%) were cured subjectively and 42 out of 46 (91.3%) were cured objectively on a stress test. The only long‐term adverse outcome was de novo overactive bladder (OAB) symptoms, which were reported by 15 out of 46 (32.6%) women at 17‐year follow‐up. This is not surprising, as it is well known that the prevalence of OAB increases with age [3], and obviously these women were significantly older when assessed at 17‐year follow‐up than when their TVTs were inserted. Unfortunately, despite the use of quality‐of‐life outcome measures (Patient Global Impression of Improvement and patient satisfaction scores), the authors have not reported the overall change in quality of life. This could be important when considering cure of SUI at the possible expense of developing OAB symptoms in later life. Most importantly, there were no reported TVT‐associated complications requiring release or resection of the TVT, nor were there any erosions into the vagina, bladder or urethra.

Although the use of all mid‐urethral tapes for urinary incontinence and meshes for pelvic organ prolapse was suspended by the Scottish Health Minister in 2014, because of concerns regarding a perceived high complication rate, brought about by a group of vocal campaigners and fuelled by the press, the final report published in 2017 recommended that women choosing surgery for SUI should be offered all available options including mesh and non‐mesh procedures [4]. Similarly, the final NHS England mesh report in 2017 [5] supported the use of retropubic mid‐urethral tapes rather than the trans‐obturator route, and the European (SCENIHR) Report [6] concluded that mesh for SUI is safe and should continue to be offered as a choice for women seeking surgery for their SUI.

Obviously, a wide range of options is available for the management of SUI, and conservative measures including pelvic floor muscle training should be offered first. For those women who do not desire a surgical solution, duloxetine is available and can be very effective when adequately tolerated. For those women who wish to undergo surgery, however, the main choices are a bulking agent, mid‐urethral tape, colposuspension or an autologous fascial sling. From all the reports and published literature to date the TVT would appear to be as, if not more, effective than all other procedures without having a higher complication rate. The data in the present paper by Braga et al. [1] should reassure healthcare providers that TVT continues to be a safe and effective surgical strategy for the management of SUI in women.

 

Linda Cardozo
Department of Urogynaecology, Kings College HospitalLondon, UK

 

References
  • Braga A, Caccia G, Sorice P, et al. Tension‐free vaginal tape for treatment of pure urodynamic stress urinary incontinence: efficacy and adverse effects at 17‐year follow‐upBJU 2018122: 113–7

 

  • Nilsson CG, Palva K, Aarnio R, et al. Seventeen years’ follow‐up of the tension free vaginal tape procedure for female stress urinary incontinenceInt Urogynaecol J. 201324: 1265–69

 

  • Milsom I, Abrams P, Cardozo L, et al. How widespread are the symptoms of an overactive bladder and how are they managed? A population based prevalence studyBJU Int 200188: 807

 

  • 4 The Scottish Independent Review of the Use, Safety and Efficacy of Transvaginal Mesh Implants in the Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse in Women: Final Report March 2017

 

 

  • European (SCENIHR) Report Opinion on the Safety of Surgical Meshes Used in Urogynecological Surgery. December 2015

 

Comments are now closed for this article

Article of the Week: LAPPRO trial – Oncological and Functional Outcomes 1 Year after RP for Very-Low-Risk PCa

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 video from Dr. Stefan Carlsson, Dr. Anna Wallerstedt and Dr Rodolfo Sanchez, discussing their paper.

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

Oncological and functional outcomes 1 year after radical prostatectomy for very-low-risk prostate cancer: results from the prospective LAPPRO trial

Stefan Carlsson*, Fredrik Jaderling, Anna Wallerstedt*, Tommy NybergJohan Stranne§
, Thordis Thorsteinsdottir, Sigrid V. Carlsson**, Anders Bjartell††Jonas Hugosson§, Eva Haglind‡‡ and Gunnar Steineck,§§

 

*Department of Molecular Medicine and Surgery, Section of Urology, Karolinska Institutet, Department of Molecular Medicine and Surgery, Section of Radiology, Karolinska Institutet, Department of Oncology and Pathology, Division of Clinical Cancer Epidemiology, Karolinska Institutet, Stockholm, §Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Faculty of Nursing, School of Health Sciences, University of Iceland, Iceland, **Department of Surgery (Urology Service), Memorial Sloan Kettering Cancer Center, New York, NY, USA, ††Department of Urology, Skane University Hospital, Lund University, Lund‡‡ Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, and §§Division of Clinical Cancer Epidemiology, Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden

 

Carlsson-et-al-infographic-cropped

 

Click on image for full size infographic

 

Objectives

To analyse oncological and functional outcomes 12 months after treatment of very-low-risk prostate cancer with radical prostatectomy in men who could have been candidates for active surveillance.

Patients and Methods

We conducted a prospective study of all men with very-low-risk prostate cancer who underwent radical prostatectomy at one of 14 participating centres. Validated patient questionnaires were collected at baseline and after 12 months by independent healthcare researchers. Biochemical recurrence (BCR) was defined as prostate-specific antigen (PSA) ≥0.25 ng/mL or treatment with salvage radiotherapy or with hormones. Urinary continence was defined as <1 pad changed per 24 h. Erectile function was defined as ability to achieve erection hard enough for penetration more than half of the time after sexual stimulation. Changes in tumour grade and stage were obtained from pathology reports. We report descriptive frequencies and proportions of men who had each outcome in various subgroups. Fisher’s exact test was used to assess differences between the age groups.

AugAOTW3Results

Results

Of the 4003 men in the LAPPRO cohort, 338 men fulfilled the preoperative national criteria for very-low-risk prostate cancer. Adverse pathology outcomes included upgrading, defined as pT3 or postoperative Gleason sum ≥7, which was present in 35% of the men (115/333) and positive surgical margins, which were present in 16% of the men (54/329). Only 2.1% of the men (7/329) had a PSA concentration >0.1 ng/mL 6–12 weeks postoperatively. Erectile function and urinary continence were observed in 44% (98/222) and 84% of the men (264/315), respectively, 12 months postoperatively. The proportion of men achieving the trifecta, defined as preoperative potent and continent men who remained potent and continent with no BCR, was 38% (84/221 men) at 12 months.

Conclusions

Our prospective study of men with very-low-risk prostate cancer undergoing open or robot-assisted radical prostatectomy showed that there were favourable oncological outcomes in approximately two-thirds. Approximately 40% did not have surgically induced urinary incontinence or erectile dysfunction 12 months postoperatively. These results provide additional support for the use of active surveillance in men with very-low-risk prostate cancer; however, the number of men with risk of upgrading and upstaging is not negligible. Improved stratification is still urgently needed.

Editorial: Management Dilemmas in Low-Risk Prostate Cancer

Prostate cancer is the most commonly diagnosed solid organ tumour and the second leading cause of cancer death in men in the USA. The exact path of these tumours from inception to metastasis is unclear; the same can also be said for those tumours that remain indolent. The varying genetic signatures of these tumours is the underlying determinant of the outcomes of these cancers and therein lies the key to selecting patients that do and do not need treatment for their prostate cancers. Most low-risk tumours are relatively indolent; however, some low-risk tumours have the potential to metastasise and cause mortality. The problem is that currently we do not have the ability to accurately and confidently determine the tumour’s individual risk profiles.

In the recent LAPPRO trial (LAParoscopic Prostatectomy Robot Open – a randomised, open trial of radical prostatectomy (RP) with or without lymph node dissection as part of a prospective, non-randomised, open trial comparing robot-assisted laparoscopic and open RP), the authors reported the RP results of patients with very-low-risk prostate cancer in a population-based study from Sweden compiling the results of open and laparoscopic RP over 14 centres of varying experience [1]. They reported pathological upgrading in 35% of patients and PSA recurrence in 2.1%. Functional outcomes at 1 year featured urinary continence levels of 84% and sexual potency of 44%. The overall trifecta rate at 1 year was 38%. What is important to note is that only 56% had optimal erectile function preoperatively (Sexual Health Inventory for Men score >21) and that it is unknown which patients received a full nerve preservation. Also the amount of postoperative continence and potency rehabilitation is unknown.

The results of the LAPPRO trial are not too dissimilar to data from the Medicare database publications on RP, which also take into account large populations of patients operated on at multiple institutions with variable surgical experience and volume [2]. The challenge with interpreting these data is that they often are quite variable based upon the preoperative status of the patient, type of surgery performed, surgeon experience, and institutional volumes [3]. If you compare the Medicare data or LAPPRO trial outcomes to large-volume single-surgeon series you often will see wide variances in outcomes favouring the single-surgeon experience. Single-surgeon and large-volume series have reported better outcomes often due to improved surgical experience, techniques, and outcomes overall [4].

Active surveillance is usually the primary choice for management of low- and very-low-risk prostate cancer lesions. However, some patients do still chose to undergo surgery due to personal choice, often related to the uncertainty associated with the diagnosis and the unknown risk of progression [5]. One would assume that low-risk tumours have a low risk of progression and metastasis; however, this is not always the case due to the varying genetic signature of the individual tumours. Also, recent studies have shown that in patients diagnosed with low-risk prostate cancer 30–50% have non-low-risk disease harbouring intermediate- or high-risk prostate cancer instead [1, 6]. This uncertainty on the part of the patient and physician can cause anxiety in patients and sometime influence their decision for treatment [7].

One would assume that patients with low- and very-low-risk patients are ideal candidates for the trifecta due to low tumour aggressiveness and volume. However, many factors influence patient outcome beyond the characteristics of the tumour. Preoperative features such as co-morbidities and pre-existing sexual dysfunction or incontinence are influential. Operative and postoperative factors include: surgeon experience, institutional volume, patients body habitus, number of prior biopsies, the ability to fully spare the nerves, and various other challenges during surgery. These are all variables that must be considered when projecting the success of surgical intervention.

While the results of surgery in the LAPPRO trial were not encouraging for surgery, we do have to take the results in context and not apply them broadly or globally without some thought. The results are blurred by combining open and laparoscopic RP, many patients were not optimal candidates’ preoperatively for the trifecta, many did not have a full nerve preservation and also many different institutions with varying levels of surgeon experience are analysed. This population was also ‘captive’, as they had to choose surgeons in their own locality, these ‘local’ surgeons may not have had the necessary experience or technique to achieve optimal outcomes. The conclusion that can be drawn is that if you sample a broad population of surgeons then the results are often quite poor due to the varying levels of skill of the surgeon and the varying level of surgical volume and experience. What the patients should glean from this is the fact that they should consider active surveillance for these types of tumours to avoid the associated morbidity. In addition, if they were to seek therapy they should select centres with higher surgical experience and proven outcomes.

For those patients that have low-risk tumours and seek treatment; judicious counselling of expectations must be performed by their healthcare advocate. Both the patient and physician must take the responsibility in making the correct assumptions and decisions. The physician must re-emphasise the available data and the low likelihood of progression in these tumours adding some caution from the fact that some of these may be upgraded. Patients must be given accurate data in the correct context. Most patients who have treatment for prostate cancer whether it be radiation, ablation or removal have a high chance of some deficit in the quality of life, functional recovery of urinary continence, and sexual potency. Educating the patient and managing realistic expectations is often the most important factor in patient satisfaction. Patients must take into account their own preoperative medical and functional status to properly stratify expectations.

If these patients after appropriate counselling are still intent to undergo surgery they should consider seeking centres with high-volume and individualised surgeons with proven quality outcomes. Large-volume single-surgeon series do show improvements in the trifecta outcomes [4]. However, none have shown perfect trifecta rates. No matter what method of treatment patients chose there would be some varying level of loss of functional outcome. The balance between cancer progression and quality of life must be weighted. For low-risk patients, we need to have a better road map of the genetic signatures of their tumour and only then will we be able to confidently tell our patients who will and who will not have the potential to harbour high-risk disease and potentially have mortality from the tumour. Until we are able to confidently deliver this information to the patient, many with low-risk disease will still seek treatment and endanger their quality of life. The recent increase in the availability of biomarkers to examine prostate biopsy specimens for risk stratification is encouraging, yet still in its infancy. Further study of these biomarkers will enhance our ability to read the genetic signature of prostate cancers at an early state and more appropriately risks stratify our patients.

The LAPPRO trial supports active surveillance as the primary choice for low- and very-low-risk tumours. However, their results are exclusive to their patient population and level of surgical experience. A similar trial with a high-volume experienced surgeon would undoubtedly show more optimistic results. Managing reasonable expectations, risk stratification, and picking expertise and experience, often makes the difference between a good and poor outcome.

 

Vipul R. Patel*† and Hariharan Palayapalayam Ganapathi*
*Global Robotics Institute, Florida Hospital Celebration Health, and University of Central Florida School of Medicine, Orlando, FL, USA

 

References

 

 

Video: LAPPRO trial – Oncological and Functional Outcomes 1 Year after RP for Very-Low-Risk PCa

Oncological and functional outcomes 1 year after radical prostatectomy for very-low-risk prostate cancer: results from the prospective LAPPRO trial

Stefan Carlsson*, Fredrik Jaderling, Anna Wallerstedt*, Tommy NybergJohan Stranne§
, Thordis Thorsteinsdottir, Sigrid V. Carlsson**, Anders Bjartell††Jonas Hugosson§, Eva Haglind‡‡ and Gunnar Steineck,§§

 

*Department of Molecular Medicine and Surgery, Section of Urology, Karolinska Institutet, Department of Molecular Medicine and Surgery, Section of Radiology, Karolinska Institutet, Department of Oncology and Pathology, Division of Clinical Cancer Epidemiology, Karolinska Institutet, Stockholm, §Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Faculty of Nursing, School of Health Sciences, University of Iceland, Iceland, **Department of Surgery (Urology Service), Memorial Sloan Kettering Cancer Center, New York, NY, USA, ††Department of Urology, Skane University Hospital, Lund University, Lund‡‡ Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, and §§Division of Clinical Cancer Epidemiology, Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden

 

Objectives

To analyse oncological and functional outcomes 12 months after treatment of very-low-risk prostate cancer with radical prostatectomy in men who could have been candidates for active surveillance.

Patients and Methods

We conducted a prospective study of all men with very-low-risk prostate cancer who underwent radical prostatectomy at one of 14 participating centres. Validated patient questionnaires were collected at baseline and after 12 months by independent healthcare researchers. Biochemical recurrence (BCR) was defined as prostate-specific antigen (PSA) ≥0.25 ng/mL or treatment with salvage radiotherapy or with hormones. Urinary continence was defined as <1 pad changed per 24 h. Erectile function was defined as ability to achieve erection hard enough for penetration more than half of the time after sexual stimulation. Changes in tumour grade and stage were obtained from pathology reports. We report descriptive frequencies and proportions of men who had each outcome in various subgroups. Fisher’s exact test was used to assess differences between the age groups.

AugAOTW3Results

Results

Of the 4003 men in the LAPPRO cohort, 338 men fulfilled the preoperative national criteria for very-low-risk prostate cancer. Adverse pathology outcomes included upgrading, defined as pT3 or postoperative Gleason sum ≥7, which was present in 35% of the men (115/333) and positive surgical margins, which were present in 16% of the men (54/329). Only 2.1% of the men (7/329) had a PSA concentration >0.1 ng/mL 6–12 weeks postoperatively. Erectile function and urinary continence were observed in 44% (98/222) and 84% of the men (264/315), respectively, 12 months postoperatively. The proportion of men achieving the trifecta, defined as preoperative potent and continent men who remained potent and continent with no BCR, was 38% (84/221 men) at 12 months.

Conclusions

Our prospective study of men with very-low-risk prostate cancer undergoing open or robot-assisted radical prostatectomy showed that there were favourable oncological outcomes in approximately two-thirds. Approximately 40% did not have surgically induced urinary incontinence or erectile dysfunction 12 months postoperatively. These results provide additional support for the use of active surveillance in men with very-low-risk prostate cancer; however, the number of men with risk of upgrading and upstaging is not negligible. Improved stratification is still urgently needed.

Article of the Week: Muscolofascial Reconstruction after RP

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 video from Dr. Francesco Alessandro Mistretta, discussing his paper.

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

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 MottrieAlexander 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

 

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.

 

 

Editorial: The Jury on Posterior Muscolofascial Reconstruction is still out

In their systematic review and meta-analysis, Grasso et al. [1] address the question of whether posterior muscolofascial reconstruction (PMR), the so-called Rocco stitch, positively affects urinary continence after radical prostatectomy. The relevance of the question to this structured form of inquiry is that individual studies to date have been inconclusive. We recognize Sir Archie Cochrane, who gave his name to the Cochrane Collaboration that pioneered the methods for conducting systematic reviews, for emphasizing the critical importance of looking at the entire body of evidence in a structured manner when seeking to answer a clinical question [2]. In the present study, which included both randomized controlled trials (RCTs) and observational studies of variable methodological quality, a favourable impact of PMR across all postoperative time points (3–7 days, 30 days, 3 and 6 months) was observed. The effect was most pronounced early on at the time of catheter removal, when the patients undergoing PMR were nearly twice as likely as the control group (risk ratio 1.9; 95% CI 1.3–2.9) to be continent, thereby suggesting a major benefit of this approach. It should be noted, however, that this analysis was dominated by the observational studies, particularly retrospective observational studies, which offer the least degree of methodological rigor.

Even more important, therefore, than the act of pooling across studies is the rating of the quality of evidence for the body of evidence on an outcome-specific basis. Based on the GRADE approach, which has become the most widely endorsed framework for rating the quality of evidence, we would initially place a high and low level of confidence in a body of evidence drawn from RCTs and observational studies, respectively [3]. As a result, one might plan a separate analysis of those two groups of studies first, and only move to pool them if their results were similar. In this case, the results from the RCTs and observational studies were different, with prospective and retrospective studies reporting larger, probably exaggerated effect sizes; however, it is also understood that other aspects such as study limitation (risk of bias), inconsistency, impression, indirectness and risk publication bias may lower our confidence in the effect estimates from RCTs [4]. Focusing on the body of evidence from RCTs alone (Table 1) we have ‘moderate’ confidence that PMR may not improve early continence at the time of catheter removal. Similarly, the few RCTs that contributed to the assessment of continence at later timepoints do not provide evidence that continence is affected favourably, although our confidence for those outcomes is only ‘low’ or ‘very low’, suggesting that future trials may change these estimates of effect. Meanwhile, it should be noted that none of the RCTs appeared to provide information on the potential downsides of PMR, such as rates of urinary retention or bladder neck contracture. As a result, enough uncertainty remains to state that the jury on PMR is still out; this is consistent with the authors’ call for a future high-quality trial, which is reportedly ongoing. While PMR is already widely used by open and robot-assisted prostatectomy surgeons around the globe, this example sheds light on current evidentiary standards of surgical innovation. Following the IDEAL recommendations, it would be much preferred if the urological community committed to well designed trials for novel surgical approaches and device-dependent interventions up front, before moving to widespread dissemination [5].

JulEOTW2

Philipp Dahm
Department of Urology, Minneapolis VA Health Care System, Urology Section 112D and University of Minnesota, Minneapolis, MN, USA

 

References

 

 

2 Hajebrahimi S, Dahm P, Buckingham J. Evidence-based urology in practice: the cochrane library. BJU Int 2009; 104: 10489

 

3 Caneld SE, Dahm P. Rating the quality of evidence and the strength of recommendations using GRADE. World J Urol 2011; 29: 3117

 

4 Guyatt GH, Oxman AD, Vist GE et al. GRADE: what is quality of evidence and why is it important to clinicians? BMJ 2008; 336: 9958

 

5 McCulloch P. The IDEAL recommendations and urological innovation. World J Urol 2011; 29: 3316

 

Video: Posterior Muscolofascial Reconstruction after RP

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 MottrieAlexander 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

 

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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