Related Experiment Videos
The 24-mo Outcomes from the Noninferiority Randomised Controlled Trial of Surgery for Men with Urodynamic Stress
Lynda Constable1, Marcus J Drake2, David Cooper1
1Aberdeen Centre for Evaluation, University of Aberdeen, Aberdeen, UK.
Background:
The artificial urinary sphincter (AUS) is the most common surgical procedure for persistent stress urinary incontinence (SUI) after prostate surgery, whereas the male sling is a newer alternative.
Objective:
To compare the 24-mo outcomes of the sling versus the AUS.
Design, Settings, And Participants:
This was an unblinded, noninferiority randomised controlled trial including men from 27 UK urological centres with bothersome urodynamic SUI after prostate surgery.
Intervention:
Men were randomised to receive a transobturator sling (n = 190) or an AUS (n = 190). Randomisation was minimised by type of surgery (radical prostatectomy/transurethral resection of the prostate), previous radiotherapy for prostate cancer (yes/no), and centre.
Outcome Measurements And Statistical Analysis:
The primary outcome was self-reported continence (a composite outcome derived from two items in the validated International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form [ICIQ-UI SF]) at 12 mo after randomisation, with a noninferiority margin of 15%, via postal questionnaire. The secondary outcomes were self-reported continence, further treatments, patient-reported measures and serious adverse events up to 24 mo.
Results And Limitations:
A total of 380 participants were included. In terms of continence, the sling was noninferior to the AUS at 24 mo (estimated absolute risk difference in the intention-to-treat analysis, -0.006; 95% confidence interval [CI], -0.092 to 0.080; noninferiority p = 0.001), indicating lower success in the sling group, but with a CI excluding the noninferiority margin. Incontinence symptom scores (ICIQ-UI SF) decreased from 16.1 and 16.4 at baseline to 7.9 and 7.1 in the sling and AUS groups, respectively. The mean difference was 1.4 (95% CI, 0.2-2.6; p = 0.024). Secondary outcomes favoured the AUS over the sling. By 24 mo, more men underwent further surgery after receiving a sling (n = 20, 11%) than after receiving an AUS (n = 4, 2%).
Conclusions:
The 24-mo results confirm that the sling is noninferior to the AUS. Symptoms and quality of life significantly improved in both groups. Overall, secondary and post hoc analyses favour the AUS.
Patient Summary:
Continence levels and symptoms improve with both surgeries. Most men are satisfied with their surgery, despite not being completely dry. Almost all other results show that men who have an artificial urinary sphincter have better outcomes than those who have a sling. Trial registration International Randomised Controlled Trial Registry, ISRCTN49212975. This trial was registered on July 22, 2013, and participants were randomised between January 29, 2014, and December 28, 2017.
