A multicentre pilot study to assess the feasibility of a future randomised controlled trial to investigate whether carrying out invasive bladder function tests in women about to undergo operations for stress incontinence alters the outcome of their surgery

Not Applicable

Completed

• Conditions: Stress urinary incontinence in women; Urological and Genital Diseases; Other disorders of urinary system

• Registration Number: ISRCTN71327395
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Brief Summary

2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21733166 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25714493 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26350343 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25714493 2016 substudy results in: http://www.ncbi.nlm.nih.gov/pubmed/27782847 2018 cost-effectiveness results in: http://www.ncbi.nlm.nih.gov/pubmed/29588862

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-07
• Study Completion: 2012-12-31
• Last Update Posted: 30 April 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

Women with a clinical diagnosis of stress urinary incontinence or stress predominant mixed urinary incontinence, who have completed their family, and have undergone a course of pelvic floor muscle training (+/- other non-surgical treatments for their urge symptoms) with inadequate resolution of their symptoms, where both the woman and clinician agree that surgery would be an appropriate and acceptable next line of treatment.

Exclusion Criteria

1. Symptomatic utero-vaginal prolapse requiring treatment
2. Previous surgery for urinary incontinence or pelvic organ prolapse
3. Neurological disease causing urinary incontinence
4. Unable to give competent informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified