Urology Week 2021: International effort against incontinence taboo

Prof. Jean-Nicolas Cornu Dept of Urology Charles Nicolle University Hospital Rouen (FR)

Jean-Nicolas.Cornu@ chu-rouen.fr

A specific context Stress urinary incontinence (SUI) after prostatic surgery (post-prostatectomy incontinence (PPI)) is a daily challenge for urologists. Most cases of PPI are transient, as many patients fully regain their continence after one year. [1] Persistent symptoms after 12 months may require specific management, depending on symptoms severity, associated bother, and global clinical picture. While PPI is mostly a consequence of radical prostatectomy (around 10% of cases), SUI can also happen after benign prostatic obstruction relief surgery. [2] Despite several possible explanations, the pathophysiology of PPI is rather seen as a confluence of several factors and remains poorly elucidated. The main hypothesis is a deficiency of the striated sphincter.

Patients seeking care for persistent PPI are in a very specific situation. First, their symptoms are iatrogenic (by definition). Gathering details about index prostatic surgery, and taking a complete medical history (including co-morbidities, pelvic radiation history, and oncologic outcomes) is the first step of adequate and personalised management. [3] The second step is to assess the symptoms as precisely as possible, as SUI can be isolated or associated with other lower urinary tract symptoms, such as overactive bladder or voiding difficulties. Severity of incontinence is a crucial point. Today there is no consensus about the definition of mild, moderate or severe SUI, but the most widely used tool is 24-hr pad test, with a cut-off around 250 ml. [4]

Beyond clinical evaluation, additional work-up may be proposed. Endoscopy can rule out urethral stenosis or anastomotic stricture, or concomitant bladder disease. Urodynamic studies are useful to assess any associated detrusor dysfunction, especially in case of mixed incontinence.

Principle of clinical management Patients with PPI usually use collecting devices such as pads, and less frequently penile sheaths or penile clamps. While the two latter are possible palliative options and can offer some advantages over standard pads [5], they require specific information, explanation and prescription. The first contact with the patient is the best occasion to deliver adequate information of availability of these products.

The next discussion is about treatment options. While the solution may be surgical in most cases (see below), possible medical options include bladder training, physiotherapy and duloxetine. [1] Bladder training and dietary measures (e.g. adequate fluid intake) can always be an option since they are not harmful, but their efficacy remains elusive. Physiotherapy, including pelvic floor muscle training, has been widely proposed but very often patients already do this within the early post-operative period. The role of electrical stimulation and biofeedback remains unclear. Among drugs, duloxetine has been studied for PPI management with encouraging results but in smaller studies to date. [6] The optimum dosage remains unknown. The patient has to be warned about off-label use in this indication, and about potential adverse events specific to this drug. Drug treatment (mainly antimuscarinics and beta-3-adrenergics) can be options for treating an associated storage component of symptoms. [7]

In case of failure of conservative measures, surgical treatment is required. Many surgical options are today available since the introduction of the AMS800™ artificial urinary sphincter marketed in 1972 and in its current shape since the early 80’s (see figure). [8] Alternatives are peri-urethral injections, male slings (either autologous, synthetic bone-anchored (not anymore used), synthetic fixed placed by transobturator route (popular today), or adjustable, peri-urethral balloons (Pro-ACT™ device), and innovative sphincters. [9] Growing evidence The level of evidence regarding the use of antiincontinence device implantation in men has been historically poor, based on mostly retrospective cohort studies performed at the end of the last century. [9] Artificial sphincter has always been considered as the gold standard based on these old data and gigantic clinical experience by urologists worldwide. In the last 20 years, more stringent requirements have been set up for introducing new implantable devices, in line with stronger market regulations, diffusion of evidence-based medicine, and strengthening of guidelines processes. For these reasons, newly released minimally invasive options (mostly male slings and Pro-ACT™) have been studied through more rigorous clinical protocols, including prospective design, comparative trials, and clearer efficacy endpoints. However, up to 2020, only level 2 evidence has been published, with the field lacking a large-scale randomised controlled trial to increase the degree of evidence. [10]

MASTER trial The MASTER trial is a multicentre, randomised controlled trial (RCT) evaluating the efficacy of transobturator male sling compared to standard AMS800™ device for PPI management (after radical prostatectomy or benign prostatic obstruction surgery). [11] In this non-inferiority trial, 380 men with PPI were randomised in 27 UK recruiting centres. The main outcome criterion was incontinence symptoms 12 months after randomisation, and non-inferiority was proven. However, the rather strict definition of incontinence (‘any self-reported symptom of incontinence at 12 months’) led to somewhat surprising results, with 87% incontinent men in the male sling group versus 84.2% in the artificial sphincter group. Secondary analysis has shown that men with > 250 g leakage at baseline did better after an AUS, especially regarding satisfaction. Few severe adverse events were reported (6 after sling and 11 after AUS implantation).

Unsolved issues Although it brings major information, and level 1 evidence supporting the use of transobturator male slings as well as the use of AUS, some issues remain unsolved.

First, the efficacy of transobturator male sling in the long term remains largely unknown. In case of failure, a subsequent AUS implantation can however be proposed. Furthermore, all slings are not equal, and mixing all transobturator tapes in the same trial could appear as confusing. A number of cohort studies have shown that the complication rate after adjustable slings appears higher than after the retrourethral male sling. [12] However, no head-to-head comparison is available.

Second, patient selection is an important issue. While the MASTER trial identifies a trend towards a superiority of AUS in more severe cases, results do not reach statistical significance. However, this is in line with previous reports suggesting that severe incontinence > 250 grams per day, pelvic radiation history, prior anti-incontinence surgery and previous urethral surgery are important factors to consider for patient selection for a male sling. [13]

Third, patient preference is a really important issue. Since non-inferiority is established between AUS and slings, patients would rather opt for the less invasive option, as previous papers have already shown. The role of the surgeon is to provide complete, independent, expert and adequate counselling in this field.

New level of evidence Recent advances in the field of PPI have set a new level of evidence, possibly impacting the guidelines and recommendations. More than before even, transobturator slings and artificial sphincter are the leading surgical options among the surgical armamentarium (see figure 1). Patient selection is the major challenge when choosing the way to treat PPI.

References

1. Rahnama'i MS, Marcelissen T, Geavlete B, Tutolo M, Hüsch

T. Current Management of Post-radical Prostatectomy

Urinary Incontinence. Front Surg. 2021 Apr 9;8:647656 2. Sabbagh P, Dupuis H, Cornu JN. State of the art on stress incontinence management after benign prostatic obstruction surgery. Curr Opin Urol. 2021 Sep 1;31(5):473478 3. Clark CB, Kucherov V, Klonieck E, Shenot PJ, Das AK.

Management of urinary incontinence following treatment

of prostate disease. Can J Urol. 2021 Aug;28(S2):38-43 4. Constable L, Cotterill N, Cooper D, et al. Male synthetic sling versus artificial urinary sphincter trial for men with urodynamic stress incontinence after prostate surgery (MASTER): study protocol for a randomised controlled trial. Trials. 2018 Feb 21;19(1):131 5. Macaulay M, Broadbridge J, Gage H, et al. A trial of devices for urinary incontinence after treatment for prostate cancer. BJU Int. 2015 Sep;116(3):432-42 6. Kotecha P, Sahai A, Malde S. Use of Duloxetine for

Postprostatectomy Stress Urinary Incontinence: A

Systematic Review. Eur Urol Focus. 2021 May;7(3):618-628 7. Andersson KE. The use of pharmacotherapy for male patients with urgency and stress incontinence. Curr Opin

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JN; Young Academic Urologists Functional Urology Group. 9. The artificial urinary sphincter after a quarter of a century: a critical systematic review of its use in male non-

neurogenic incontinence. Eur Urol. 2013 Apr;63(4):681-9 10. Choinière R, Violette PD, Morin M, et al. Evaluation of

Benefits and Harms of Surgical Treatments for Post-radical

Prostatectomy Urinary Incontinence: A Systematic Review and Meta-analysis. Eur Urol Focus. 2021 Sep 22:S24054569(21)00236-4 11. Abrams P, Constable LD, Cooper D, et al. Outcomes of a

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Men with Urodynamic Stress Incontinence After Prostate

Surgery (MASTER). Eur Urol. 2021 Jun;79(6):812-823 12. Bole R, Hebert KJ, Gottlich HC, Bearrick E, Kohler TS, Viers

BR. Narrative review of male urethral sling for postprostatectomy stress incontinence: sling type, patient selection, and clinical applications. Transl Androl Urol. 2021 Jun;10(6):2682-2694 13. Grabbert M, Bauer RM, Hüsch T, et al. Patient Selection in

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Fig. 1: Surgical therapeutic approach for post-prostatectomy incontinence management