Abstract
Background: Stress urinary incontinence (SUI) is common after radical prostatectomy and likely to persist despite conservative treatment. The sling is an emerging operation for persistent SUI but randomised controlled trial (RCT) comparison with the established artificial urinary sphincter (AUS) is lacking.
Objective: compare outcomes of surgery in men with bothersome urodynamic SUI after prostate surgery.
Design, settings and participants: Non-inferiority RCT of men with bothersome
urodynamic SUI; 27 UK centres. Blinding was not possible due the surgeries.
Interventions: Participants randomly assigned (1:1) to male transobturator sling (n=190) or AUS (n=190).
Outcome measures and statistical analysis: Primary outcome: patient-reported SUI, 12 months post randomisation (PR) from postal questionnaire using a composite outcome from two items in validated ICIQ-UI SF. Non-inferiority margin was 15%, thought to be an acceptable lower effectiveness, in return for reduced adverse events (AEs) and easier operation, for the sling. Secondary outcomes: operative and post-operative details, patient reported measures, and AEs, up to 12 months post-surgery.
Results and limitations: 380 participants. At 12 months PR, incontinence rates were 134/154 (87.0%) for male sling versus 133/158 (84.2%) for AUS (difference 3.6% (95% CI -11.6 to 4.6, pNI = 0.003)), showing non-inferiority. Incontinence symptoms (ICIQ-UI SF) reduced from scores of 16.1 and 16.4 at baseline to 8.7 and 7.5, male sling and AUS respectively (MD 1.4 (95% CI 0.2 to 2.6 p = 0.02). Serious AEs (SAEs) were few; n=6 and n=13 for male sling and AUS (one man had 3 SAEs), respectively. Quality of life scores improved, satisfaction was high in both groups. All other secondary outcomes that show statistically significant differences, favour the AUS.
Conclusions: Using a strict definition, UI rates remained high, with no evidence of difference between male sling and AUS. Symptoms and QoL significantly improved in both groups and men were generally satisfied with both procedures. Overall, secondary and post61 hoc analyses were in favour of AUS.
Patient summary: Urinary incontinence after prostatectomy has considerable effect on men’s QoL. MASTER shows that if surgery is needed, both surgical options result in fewer symptoms and high satisfaction, despite most men not being completely dry. However, most other results indicate that men having AUS have better outcomes than those who have a sling
Objective: compare outcomes of surgery in men with bothersome urodynamic SUI after prostate surgery.
Design, settings and participants: Non-inferiority RCT of men with bothersome
urodynamic SUI; 27 UK centres. Blinding was not possible due the surgeries.
Interventions: Participants randomly assigned (1:1) to male transobturator sling (n=190) or AUS (n=190).
Outcome measures and statistical analysis: Primary outcome: patient-reported SUI, 12 months post randomisation (PR) from postal questionnaire using a composite outcome from two items in validated ICIQ-UI SF. Non-inferiority margin was 15%, thought to be an acceptable lower effectiveness, in return for reduced adverse events (AEs) and easier operation, for the sling. Secondary outcomes: operative and post-operative details, patient reported measures, and AEs, up to 12 months post-surgery.
Results and limitations: 380 participants. At 12 months PR, incontinence rates were 134/154 (87.0%) for male sling versus 133/158 (84.2%) for AUS (difference 3.6% (95% CI -11.6 to 4.6, pNI = 0.003)), showing non-inferiority. Incontinence symptoms (ICIQ-UI SF) reduced from scores of 16.1 and 16.4 at baseline to 8.7 and 7.5, male sling and AUS respectively (MD 1.4 (95% CI 0.2 to 2.6 p = 0.02). Serious AEs (SAEs) were few; n=6 and n=13 for male sling and AUS (one man had 3 SAEs), respectively. Quality of life scores improved, satisfaction was high in both groups. All other secondary outcomes that show statistically significant differences, favour the AUS.
Conclusions: Using a strict definition, UI rates remained high, with no evidence of difference between male sling and AUS. Symptoms and QoL significantly improved in both groups and men were generally satisfied with both procedures. Overall, secondary and post61 hoc analyses were in favour of AUS.
Patient summary: Urinary incontinence after prostatectomy has considerable effect on men’s QoL. MASTER shows that if surgery is needed, both surgical options result in fewer symptoms and high satisfaction, despite most men not being completely dry. However, most other results indicate that men having AUS have better outcomes than those who have a sling
| Original language | English |
|---|---|
| Pages (from-to) | 812-823 |
| Number of pages | 11 |
| Journal | European Urology |
| Volume | 79 |
| Issue number | 6 |
| Early online date | 4 Feb 2021 |
| DOIs | |
| Publication status | Published - Jun 2021 |
Bibliographical note
Funding Information:Funding/Support and role of the sponsor: The UK National Institute for Health Research Health Technology Assessment (NIHR HTA) programme (project number 11/106/01) is the funder of the study and approved the study proposal, but had no role in the study design, data collection, data analysis, data interpretation, or writing of the report.
Financial disclosures: Lynda D. Constable certifies that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (eg, employment/affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: Paul Abrams reports grants, personal fees and other from Astellas, and personal fees from Pfizer, Sun Pharma, Ipsen, Pierre Fabre, and Coloplast, outside of submitted work. Chris Harding reports personal fees from Astellas, Pfizer, Ferring, Allergan, and Medtronic, other from Pierre Fabre,e the submitted work. Marcus J. Drake reports personal fees and nonfinancial AMS/Boston, Astellas, and Medtronic; and grants from NIHR HTA Grant, outside support from Astellas, and personal fees from Asofarma and Ferring, outside of submitted work.
Keywords
- urodynamic stress incontinence
- male sling
- artificial urinary sphincter
- randomised controlled trial
- non-inferiority