Abstract
Background
Stress urinary incontinence (SUI) is common in men after prostate surgery (PS) and can be difficult to improve. Implantation with the artificial urinary sphincter (AUS) is the most common surgical procedure for persistent SUI but requires adequate patient dexterity to operate, specialist surgical skills, is relatively expensive and may require revisions over time. New surgical approaches include the male synthetic sling emerging as a possible alternative. However, robust comparable data on its safety and efficacy, derived from randomised controlled trials (RCT) in comparison with AUS is lacking.
Objective
To compare clinical and cost-effectiveness of male synthetic sling with AUS surgery in men with persistent SUI after PS.
Design
A multi-centre, non-inferiority RCT with a parallel non-randomised cohort (NRC), and embedded qualitative component. RCT allocation was by remote web-based randomisation (1:1), minimised on previous PS (radical prostatectomy (RP) or transurethral resection of the prostate (TURP)), radiotherapy (or not, in relation to PS), and centre. Surgeons and participants were not blind to treatment received. NRC allocation was participant and/or surgeon preference.
Stress urinary incontinence (SUI) is common in men after prostate surgery (PS) and can be difficult to improve. Implantation with the artificial urinary sphincter (AUS) is the most common surgical procedure for persistent SUI but requires adequate patient dexterity to operate, specialist surgical skills, is relatively expensive and may require revisions over time. New surgical approaches include the male synthetic sling emerging as a possible alternative. However, robust comparable data on its safety and efficacy, derived from randomised controlled trials (RCT) in comparison with AUS is lacking.
Objective
To compare clinical and cost-effectiveness of male synthetic sling with AUS surgery in men with persistent SUI after PS.
Design
A multi-centre, non-inferiority RCT with a parallel non-randomised cohort (NRC), and embedded qualitative component. RCT allocation was by remote web-based randomisation (1:1), minimised on previous PS (radical prostatectomy (RP) or transurethral resection of the prostate (TURP)), radiotherapy (or not, in relation to PS), and centre. Surgeons and participants were not blind to treatment received. NRC allocation was participant and/or surgeon preference.
| Original language | English |
|---|---|
| Article number | 184 |
| Journal | Health Technology Assessment |
| Volume | 26 |
| Issue number | 36 |
| DOIs | |
| Publication status | Published - Aug 2022 |
Bibliographical note
Funding Boards Policy Group, HTA General Board and HTA Post-board, FundingTeleconference; the NIHR Clinical Trials Unit Standing Advisory Committee; the NIHR HTA and Efficacy and Mechanism Evaluation Editorial Board; and the Pre-exposure Prophylaxis Impact Review Panel.
Acknowledgements
The authors wish to thank the men who participated in MASTER. We also thank Fiona Cherry, Lara Mitchell, Georgia Mannion-Krase, Denise Will, Rebecca Bruce, Margery Heath, Maria Ntessalen, Andrea Fraser, Dianne Dejean and Janice Cruden for their secretarial support and data management; Kirsty Shearer, Caroline Peet, Lynda Constable, Karen Campbell and Elerita Flammini for the Trial Management; Graeme MacLennan (CHaRT Director (from 2017)), the programming team in CHaRT, led by Gladys McPherson (to 2016) and Mark Forrest (2016-present), members of the PMG for their ongoing support and advice, Cynthia Fraser (HSRU) for literature searches, Nikki Cotterill, Megan Pardoe, Alan Uren and Rafiyah Khan for the qualitative research carried out in MASTER, Marcus Jepson, Jenny Donovan and the Quintet team for exploring surgeon equipoise, and the independent members of the TSC and DMC, and the staff at the recruiting sites (listed below) who facilitated recruitment, treatment and follow up of trial participants.
Keywords
- post-prostatectomy incontinence
- male incontinence
- artificial urinary sphincter
- male sling
- randomised controlled tria