📃 Paper Title: Outcomes of a Noninferiority Randomised Controlled Trial of Surgery for Men with Urodynamic Stress Incontinence After Prostate Surgery (MASTER)
🧍 Author: Abrams
🕒 Year: 2021
📚 Journal: European Urology
🌎 Country: United Kingdom
ㅤContext to the study:
Can you tell me about a study that has investigated male stress incontienence after prostatectomy?
ㅤ✅ Take-home message of study:
There was no difference in continence rates between the male sling and artificial urinary sphincter (AUS) insertion for men with post-prostatectomy incontinence.
Incontinence symptoms improved for men undergoing both treatments.
ㅤ Multi-centre, randomised, controlled, non-inferiority trial
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Study participants:
Inclusion:
Men who failed conservative management of stress urinary incontinence post prostatectomy
At least 12 months post prostatectomy
380 men were equally randomly assigned (1:1) to undergo a male sling or AUS operation
Patients were followed up for 12 months post surgery
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Key study outcomes:
The primary outcome was a composite score from the Incontinence Questionnaire-Urinary Incontinence Short Form questionnaire (ICIQ-UI SF). There was no difference in the incontinence rates between the male sling (87%) versus AUS (84.2%), confirming non-inferiority. Both interventions had significant overall improvement in symptoms with the AUS superior to sling in satisfaction surveys. The trial did not find that the male sling reduced hospital stay, lowered cost, reduced complications or had fewer reoperations in comparison to AUS at 12 months.
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Study Limitations:
ㅤ- The definition of "no incontinence" based on a PROM was very strict and this contributed to very poor incontinence outcomes (15%) in this trial compared with the literature. The inclusion criteria accepted patients with prior exposure to radiation and previously treated bladder neck contracture despite published evidence of worse incontinence rates in these settings.
ㅤ- Information on device related complications needs longer term data which will be audited at 5 years.
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