Tag Archive for: incontinence

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Article of the week: Cluster analysis of multiple chronic conditions associated with urinary incontinence among women in the USA

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. 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. There is also a new residents’ podcast focussing on this article. 

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

Cluster analysis of multiple chronic conditions associated with urinary incontinence among women in the USA

Alayne D. Markland*, Camille P. Vaughan§, Ike S. Okosun, Patricia S. Goode*, Kathryn L. Burgio*and Theodore M. Johnson II§

 

*Department of Medicine, Division of Gerontology, Geriatrics and Palliative Care, University of Alabama-Birmingham UAB School of Medicine, Birmingham/Atlanta VA Geriatric Research, Education and Clinical Center, Birmingham VA Medical Center, Birmingham, AL, Birmingham/Atlanta VA Geriatric Research, Education and Clinical Center, Atlanta VA Medical Center, Decatur, §Department of Medicine, Division of General Medicine and Geriatrics, Emory University School of Medicine and Division of Epidemiology and Biostatistics, School of Public Health, Georgia State University, Atlanta, GA, USA

 

Abstract

Objective

To identify patterns of prevalent chronic medical conditions among women with urinary incontinence (UI).

Materials and Methods

We combined cross‐sectional data from the 2005–2006 to 2011–2012 US National Health and Nutrition Examination Surveys, and identified 3 800 women with UI and data on 12 chronic conditions. Types of UI included stress UI (SUI), urgency UI (UUI), and mixed stress and urgency UI (MUI). We categorized UI as mild, moderate or severe using validated measures. We performed a two‐step cluster analysis to identify patterns between clusters for UI type and severity. We explored associations between clusters by UI subtype and severity, controlling for age, education, race/ethnicity, parity, hysterectomy status and adiposity in weighted regression analyses.

Results

Eleven percent of women with UI had no chronic conditions. Among women with UI who had at least one additional condition, four distinct clusters were identified: (i) cardiovascular disease (CVD) risk‐younger; (ii) asthma‐predominant; (iii) CVD risk‐older; and (iv) multiple chronic conditions (MCC). In comparison to women with UI and no chronic diseases, women in the CVD risk‐younger (age 46.7 ± 15.8 years) cluster reported the highest rate of SUI and mild UI severity. In the asthma‐predominant cluster (age 51.5 ± 10.2 years), women had more SUI and MUI and more moderate UI severity. Women in the CVD risk‐older cluster (age 57.9 ± 13.4 years) had the highest rate of UUI, along with more severe UI. Women in the MCC cluster (age 61.0 ± 14.8 years) had the highest rates of MUI and the highest rate of moderate/severe UI.

Conclusions

Women with UI rarely have no additional chronic conditions. Four patterns of chronic conditions emerged with differences by UI type and severity. Identification of women with mild UI and modifiable conditions may inform future prevention efforts.

 

 

Residents’ podcast: Urinary continence recovery after radical prostatectomy

Maria Uloko is a Urology Resident at the University of Minnesota Hospital and Giulia Lane is a Female Pelvic Medicine and Reconstructive Surgery Fellow at the University of Michigan.

In this podcast they discuss the BJUI Article of the Week ‘Investigating the mechanism underlying urinary continence recovery after radical prostatectomy: effectiveness of a longer urethral stump to prevent urinary incontinence‘.

 

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

Read the full article

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 the normal (straight line) and long urethral stump (dashed line) 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.

 

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Editorial: Towards an individualized approach for predicting post‐prostatectomy urinary incontinence: the role of nerve preservation and urethral stump length

Traditionally, MRI of the prostate has been mainly applied in the diagnosis and staging of prostate cancer. Kadono et al. [1] used pre‐ and postoperative pelvic MRI to assess the repositioning of the urethra 10 days and 12 months after prostatectomy, hypothesizing that these alterations could correlate with urinary incontinence and urethral function. Recent MRI measurements of anatomical structures of the pelvic floor, such as membranous urethral length and inner levator distance, were found to be independent predictors of early continence recovery at 12 months after prostatectomy [2] A meta‐analysis has also shown a strong correlation between membranous urethral length and continence recovery at 3‐, 6‐ and 12‐month follow‐up [3] Kadono et al. [1] add another metric to the pelvic floor dimensions that may help predict continence. Cranial migration of the lower end of the membranous urethra early after prostatectomy was associated with urinary incontinence and urinary sphincter function, as objectively assessed by urethral pressure profile. Interestingly, return of the membranous urethra to the more distal preoperative position after 12 months was associated with improvement in continence. In a multivariate model, urethral stump length was a strong predictor of continence outcome at 10 days as well as 12 months after prostatectomy. This observation suggests that urethral length may partly improve post-prostatectomy continence through better compression of the membranous urethra in the pelvic floor membrane rather than through transfer of the intra‐abdominal pressure onto the intra‐abdominally located urethra. If confirmed, this observation may imply that more cranial fixation of the bladder neck in a more intra‐abdominal position may not necessarily improve continence after prostatectomy, in line with data from randomized controlled studies comparing median fibrous raphe reconstruction with standard anastomosis that failed to show a benefit [4,5].

Besides anatomical location, innervation of the proximal urethra is important for post-prostatectomy continence [6]. Kadono et al. found that nerve preservation was an independent predictor of early and long‐term continence outcome, with a b value similar to that of urethral stump length at 12‐month follow‐up. To improve post-prostatectomy continence outcome, proper patient selection seems crucial. In the era of personalized medicine, MRI could be a valuable tool to assess preoperatively the risks of postoperative urinary incontinence and counsel patients accordingly. Avoiding prostatectomy in men with short preoperative membranous urethral length may be an important approach for improving outcome, in particular in light of the fact that many attempts to surgically correct anatomical alignment of the pelvic floor have not clearly improved continence outcome. If surgery is considered, nerve preservation should be performed where possible to improve continence.

Henk G. van der Poel and Nikos Grivas

Department of Urology, Netherlands Cancer Institute, Amsterdam, The Netherlands

References

  1. Kadono Y, Nohara T, Kawaguchi S et al. Investigating the mechanism underlying urinary continence recovery after radical prostatectomy: effectiveness of a longer urethral stump to prevent urinary incontinence. BJU Int 2018. 37: 463–9
  2. Grivas N, van der Roest R, Schouten D et al. Quantitative assessment of fascia preservation improves the prediction of membranous urethral length and inner levator distance on continence outcome after robot-assisted radical prostatectomy. Neurourol Urodyn 2018; 37: 417–25
  3. Mungovan SF, Sandhu JS , Akin O, Smart NA, Graham PL, Patel MI. Preoperative membranous urethral length measurement and continence recovery  following radical prostatectomy: a systematic review and meta-analysis. Eur Urol 2017; 71: 368–78
  4. Joshi N, de Blok W, van Muilekom E, van der Poel H. Impact of posterior musculofascial reconstruction on early continence after robot-assisted laparoscopic radical prostatectomy: results of a prospective parallel group trial. Eur Urol 2010; 58: 84–9
  5. Menon M, Muhletaler F, Campos M, Peabody JO. Assessment of early continence after reconstruction of the periprostatic tissues in patients undergoing computer assisted (robotic) prostatectomy: results of a 2 group parallel randomized controlled trial. J Urol 2008; 180: 1018–23
  6. van der Poel HG, de Blok W, Joshi N, van Muilekom E. Preservation of lateral prostatic fascia is associated with urine continence after robotic-assisted prostatectomy. Eur Urol 2009; 55: 892–900Dearnaley DP, Jovic G, Syndikus I et al. The. Lancet Oncol 2014; 15:464–73

 

Video: Urinary continence recovery after radical prostatectomy

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

Read the full article

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.

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.

 

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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

Read the full article

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.

 

Read more articles of the week

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

 

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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.

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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

 

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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

 

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AUS outcomes in irradiated vs non-irradiated patients

Outcomes of artificial urinary sphincter implantation in the irradiated patient

Niranjan J. Sathianathen, Sean M. McGuigan* and Daniel A. Moon*

Faculty of Medicine, Nursing and Health Sciences, Monash University, and *Epworth HealthCare, Melbourne, Vic., Australia

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OBJECTIVES

• To present the outcomes of men undergoing artificial urinary sphincter (AUS) implantation.

• To determine the impact a history of radiation therapy has on the outcomes of prosthetic surgery for stress urinary incontinence.

PATIENTS AND METHODS

• A cohort of 77 consecutive men undergoing AUS implantation for stress urinary incontinence after prostate cancer surgery, including 29 who had also been irradiated, were included in a prospective database and followed up for a mean period of 21.2 months.

• Continence rates and incidence of complications, revision and cuff erosion were evaluated, with results in irradiated men compared with those of men who had undergone radical prostatectomy alone.

• The effect of co-existing hypertension, diabetes mellitus and surgical approach on outcomes were also examined.

RESULTS

• Overall, the rate of social continence (0–1 pad/day) was 87% and similar in irradiated and non-irradiated men (86.2 vs 87.5%). Likewise, the incidence of infection (3.4 vs 0%), erosion (3.4 vs 2.0%) and revision surgery (10.3 vs 12.5%) were not significantly different between the groups.

• There was a far greater incidence of co-existing urethral stricture disease in irradiated patients (62.1 vs 10.4%) which often complicated management; however, AUS implantation was still feasible in these men and, in four such cases, a transcorporal cuff placement was used.

• There were poorer outcomes in patients with diabetes, and a greater re-operation rate in those men who underwent a transverse scrotal rather than perineal surgical approach, although the differences did not reach statistical significance.

CONCLUSIONS

• Previous irradiation in patients may increase the complexity of treatment because of a greater incidence of co-existing urethral stricture disease; however, these patients are still able to achieve a level of social continence similar to that of non-irradiated patients, with no discernable increase in complication rates, cuff erosion or the need for revision surgery.

• AUS implantation remains the ‘gold standard’ for management of moderate-to-severe stress urinary incontinence in both irradiated and non-irradiated patients after prostate cancer treatment.

 

 

The NERI Nocturia Advisory Conference 2012: focus on outcomes of therapy

 

 

 

 

The New England Research Institutes, Inc. (NERI) Nocturia Advisory Conference 2012: focus on outcomes of therapy

Jeffrey P. Weiss1,2, Jerry G. Blaivas1,2, Marco H. Blanker9, Donald L. Bliwise3, Roger R. Dmochowski4, Marcus Drake11, Catherine E. DuBeau5, Adonis Hijaz7, Raymond C. Rosen6, Philip E.V. Van Kerrebroeck10 and Alan J. Wein8

1Department of Urology, SUNY Downstate College of Medicine, Brooklyn, 2Weill Medical College of Cornell University, New York, NY, 3Emory University School of Medicine, Atlanta, GA, 4Department of Urologic Surgery, Vanderbilt University, Nashville, TN, 5Division of Geriatric Medicine, UMass Memorial Medical Center and UMass Medical School, Worcester, MA, 6New England Research Institutes, Watertown, MA, 7Urology Institute, University Hospitals Case Medical Center, Cleveland, OH, 8Division of Urology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, 9Department of General Practice, University of Groningen, University Medical Center Groningen, Groningen, 10Department of Urology, Maastricht University Medical Center, Maastricht, The Netherlands, and 11University of Bristol, Bristol, UK

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INTRODUCTION

Nocturia, awaking to void urine, is a common and sometimes bothersome symptom that may impose detrimental impacts on sleep-quality, mood, and overall health [1]. The multi-factorial aetiology of nocturia, coupled with the recent demonstration that this symptom is highly variable over time and often resolves spontaneously [2] , makes nocturia a challenging clinical entity. Although nocturia may have little health impact for some, for others it can be a highly bothersome, debilitating condition. Multiple studies have shown an association between nocturia and disturbed sleep, reduced well-being, and increased morbidity [3, 4, 5].

A consensus statement published in 2011 provided guidance to clinicians who are confronted with the wide range of clinical presentations of nocturia [1]. That paper focused primarily on a description of nocturia, its prevalence, its impact on health-related quality of life (QOL) and overall health, and an overview of available treatment options. The present paper extends and elaborates on the previous paper by examining the most recent research on diagnostic and treatment outcomes. Numerous papers have been published in the 2 years since the previous conference was organised, and the field, as a whole, has a large and dynamic research agenda. This paper summarises the findings resulting from a 2012 conference of key thought leaders in the field of nocturia who focused on updating outcome studies published since the previous conference was held.

 

Midurethral tape surgery for incontinence; a possible victim of the vaginal mesh crisis?

Type 1 mesh is used in vaginal surgery for pelvic organ prolapse repair, along with the mid-urethral tapes for stress incontinence surgery. Tapes for incontinence surgery are well-established and systematic review shows that retropubic tape is probably more effective than colposuspension, risk of bladder perforation notwithstanding [1]. The various types of mid-urethral tape appear to have broadly equivalent efficacy, but the poor quality evidence-base is an issue. The real problem lies with the major complications that can occur, some of which are highlighted in the recent statement from the US Food & Drug Administration in response to concerns expressed by patients and other stakeholders. Mid-urethral tape itself is recognised to be at risk of important complications in the long term, and mesh exposure in the vagina is a major issue with considerable detrimental impact. Patient groups have become organised in recognition of this and they are setting up online dialogues and websites accordingly, for example “tvt-messed-up-mesh.org”. The surgical professions have to agree how best to manage the difficult problems, dealing with the exposed mesh and handling the further procedures needed to re-establish continence [2].

 

Litigation
These in themselves are serious issues, but another threat is looming; the potential that litigation arising in prolapse mesh surgery may extend to midurethral tapes. A huge number of court cases related to mesh prolapse repair has been established, affecting most of the major device manufacturers and key products, with such a volume of workload that multidistrict litigation has been established. A recent award to one claimant against Johnson & Johnson was more than $5 million. With the number of claimants running into thousands, many device companies are taking decisions on these products which will substantially affect their availability and use in the future. How this will affect mid-urethral tape is uncertain, but many companies will have strategic concerns in this area as well. Reporting of mesh-related adverse events has reasoned exponentially in the last few years [3], presumably resulting from increasing use and increasing awareness of potential problems. Self-reported complications to the FDA’s MAUDE database have risen for all forms of mesh including mid-urethral tapes. Particularly worrying is the potential that tape-related complications after tape placement can happen many years postoperatively [4].


A key aspect of the litigation relating to mesh use in vaginal prolapse surgery is the lack of premarketing testing of these devices and the weak evidence base [5]. Legal arguments involve the responsibility of the companies to demonstrate safety before marketing, and the urological profession has expressed the desirability of more stringent approaches to the development of surgical devices – especially given the highly stringent requirements for pharmaceutical companies in marketing new drugs. The professionals themselves are not blameless; preoperative counselling on risk, judicious selection of surgery according to the patients’ individual requirements, surgical training, careful follow-up and engagement where problems arise have caused difficulties in many cases previously. These points are expectations of professional practice, and the professions need to adhere to them – if necessary with input from governing bodies to ensure adherence is demonstrable. The area is rapidly changing and we can be sure that substantial dialogue and developments are predictable in the near future.
Approaches to management of tape complications
The management of mesh and tape-related complications is specialised and centralisation of management of these cases appears appropriate in order to have the best chance of acceptable outcome and to develop the necessary skills which would not be possible in centres handling only small numbers of cases. Potential complications include voiding dysfunction, mesh exposure, pain, LUTS, and persisting or recurrent incontinence. Voiding dysfunction is particularly likely if a woman already has a preoperative history of voiding symptoms, previous retropubic surgery, or if other reconstructive procedures are undertaken at the time of tape placement [6]. Voiding dysfunction can occur as a result of urethral compression by the tape – which will usually be palpable as an indentation of the urethra at its midpoint. Alternatively, voiding dysfunction arises from elevation of the endopelvic fascia – in which case, the urethra tends to be drawn upwards towards the retropubic space. In the first case, a tape incision can be effective, but in the latter case, an abdominal procedure to release the endopelvic fascia to its normal configuration might be needed. It is important to avoid instrumenting the urethra and levering the urethra downwards with an instrument placed into the urethra – this carries the risk of crushing the urethra against the tape, and is likely a major potential factor for subsequent erosion into the urethra.
The assessment of women with the tape complication needs to be comprehensive and fastidious. The considerations require awareness of tape exposure, incontinence, voiding dysfunction, proximity of adjacent structures, pain points and the state of the vagina/ labia/ pelvis. If mesh is exposed, it is essential to remove the unwanted material, though it may not be necessary to remove the entire tape. The excision of the material may leave a defect within the urethra, bladder or vagina, which needs to be closed- bearing in mind the principles for avoidance of subsequent fistula formation (i.e. watertight closure and interposition of healthy tissue between repaired structures). The woman will seek continence postoperatively and to deliver this, both the bladder outlet and the reservoir capacity of the bladder will need to be considered. If necessary, the woman may need to self-catheterise afterwards, and whether the patient will find this practical and acceptable must be confirmed preoperatively. The possibility that the planned operation may fail has to be considered, and accordingly steps taken to ensure that subsequent options are not excluded. For example, excision of mesh may best be achieved with placement of a flap of omentum into the area of the defect, to keep open the subsequent possibility of artificial urinary sphincter placement. It is very clear that extensive experience in all aspects of reconstructive urology are needed in order to get the best outcome in this context.
The looming threats
The immediate future sees several key challenges, including:
1. Training of surgeons in primary incontinence surgery to minimise risk of complications arising
2. Training of surgeons to manage complications
3. Regulatory arrangements as authorities come to grips with major complications occurring with significant incidence
4. Strategic concerns as device companies change their view of the merit of this indication for their profitability
5. The need for proper data on device use, outcomes and adverse consequences
6. The ongoing need to find new management options for improving efficacy and safety in surgical management of incontinence

Professional consensus and dialogue is clearly a high priority to ensure a good outcome for all.

 

Dr Marcus Drake is Consultant Surgeon at the Bristol Urological Institute, Bristol, UK, subspecialising in Female and Reconstructive Urology, Neurourology and Urodynamics He is Chairman of the International Continence Society’s Standardisation Steering Committee

References
1. Novara, G., et al., Updated systematic review and meta-analysis of the comparative data on colposuspensions, pubovaginal slings, and midurethral tapes in the surgical treatment of female stress urinary incontinence. Eur Urol, 2010. 58(2): p. 218-38.
2. Smith, A.R., W. Artibani, and M.J. Drake, Managing unsatisfactory outcome after mid-urethral tape insertion. Neurourol Urodyn, 2011. 30(5): p. 771-4.
3. Shah, H.N. and G.H. Badlani, Mesh complications in female pelvic floor reconstructive surgery and their management: A systematic review. Indian journal of urology : IJU : journal of the Urological Society of India, 2012. 28(2): p. 129-53.
4. Jones, R., et al., Risk of tape-related complications after TVT is at least 4%. Neurourol Urodyn, 2010. 29(1): p. 40-1.
5. Abrams, P., et al., Synthetic vaginal tapes for stress incontinence: proposals for improved regulation of new devices in Europe. Eur Urol, 2011. 60(6): p. 1207-11.
6. Molden, S., et al., Risk factors leading to midurethral sling revision: a multicenter case-control study. Int Urogynecol J Pelvic Floor Dysfunct, 2010. 21(10): p. 1253-9.

 

 

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