Adjustable anchored Single-Incision Mini-Slings versus standard tension-free mid-urethral slings in the surgical management of female stress urinary incontinence: a pragmatic multicentre non-inferiority randomised controlled trial

niversity of Aberdeen (UK)0 个研究点目标入组 600 人开始时间: 2014年1月14日最近更新: 2023年9月11日

试验速览

2017 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/28801396 protocol 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36520097/ (added 16/12/2022) 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/37052645/ Secondary analysis describing Aberdeen Home Continence Stress Test (HCST) (added 14/04/2023) 2023 Other publications in https://doi.org/10.1136/bmjopen-2022-066157 Patient preferences for stress urinary incontinence treatments: a discrete choice experiment (added 30/08/2023)

•1. Women aged 18 years or over with stress urinary incontinence (SUI), who have been referred to one of the collaborating units from across the UK, and for whom surgery has been indicated
•2. Women will have completed their families, failed or declined conservative treatment (supervised pelvic floor muscle training - PFMT)
•3. All women will have urodynamic stress incontinence, or urodynamic mixed urinary incontinence with predominant SUI bothering symptoms
•4. The small group of women with pure symptoms and signs of SUI and no symptoms of overactive bladder (OAB) or voiding dysfunction (VD) can be included without urodynamic investigations as per the updated NICE guidelines

•1. Anterior or apical prolapse = pelvic organ prolapse quantification score (POP-Q) Stage 2
•2. Previous incontinence surgery (for SUI or OAB)
•3. Mixed incontinence with pre-dominant OAB symptoms (defined as OAB failed to be controlled on conservative treatment such as bladder retraining, PFMT and/or anti-muscarinic treatment)
•4. Neurological conditions e.g. MS, spinal cord injuries
•5. Concomitant surgery at time of SUI surgery
•6. Previous pelvic irradiation
•7. Pregnancy or planning for a family
•8. Inability to understand the information leaflet and consent form in English

发起方

niversity of Aberdeen (UK)