Evaluation of Benefits and Harms of Surgical Treatments for Post-radical Prostatectomy Urinary Incontinence: A Systematic Review and Meta-analysis.

CONTEXT: No meta-analysis has comprehensively addressed both benefits and harms, or the certainty of evidence of the implantable continence devices used in men to treat postprostatectomy urinary incontinence (PPI).

OBJECTIVE

To evaluate the benefits and harms of surgical treatments for patients suffering from PPI and assess the certainty of evidence. The primary benefit was cure (one or fewer pad per day), and the primary harm was reoperations defined by surgical procedures following implantation.

EVIDENCE ACQUISITION: We perform a search of Medline, PubMed, Embase, Cochrane Library, and gray literature. We included observational studies addressing PPI surgical interventions if they involved cohorts of ≥50 participants. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach provided the framework for certainty of evidence assessment informed by value and preference judgments provided by patients, and an advocacy group member (Canadian Cancer Society).

EVIDENCE SYNTHESIS: Of 85 observational studies involving 13 100 patients, three addressed bulking agents, 35 male synthetic slings, ten adjustable continence therapies (ACTs), and 37 artificial urinary sphincters (AUSs). Cure was 26.1% (95% confidence interval [CI]: 10.6-51.4, I2 = 92.8%, very-low-quality evidence) for bulking agents, 58.6% (95% CI: 51.3-65.5, I2 = 89.1%, low-quality evidence) for slings, 63.2% (95% CI: 57.6-68.5, I2 = 22.5%, very-low-quality evidence) for ACT, and 74.0% (95% CI:61.2-83.7, I2 = 92.1%, very-low-quality evidence) for AUS. Estimated rates of reoperation were 5.8% (95% CI: 1.9-11.6, I2 = 94.1%, moderate-quality evidence) for slings, 23.8% (95% CI: 5.9-61.0, I2 = 95.5%, low-quality evidence) for ACT, and 22.2% (95% CI: 15.2-31.3, I2 = 92.3%, high-quality evidence) for AUS.

CONCLUSIONS

Available evidence regarding the benefits of surgical interventions for PPI remains mainly uncertain while suggesting important harms. These results should guide consent procedures for PPI surgery in the context of shared decision-making, with disclosure of the uncertainty of evidence.

PATIENT SUMMARY: Despite being used worldwide, available evidence regarding the benefits of surgeries to treat postprostatectomy urinary incontinence remains mainly uncertain while suggesting important harms. This highlights the need for a more rigorous evaluation process for commercially available surgical devices.