ISRCTN71327395Completed未知
INVasive Evaluation before Surgical Treatment of Incontinence Gives Added Therapeutic Effect?: a pragmatic multicentre pilot study to assess the feasibility of a future randomised controlled trial
ewcastle upon Tyne Hospitals NHS Foundation Trust (UK)0 sites120 target enrollmentStarted: June 7, 2010Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 120
Study Overview
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
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- Female
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
Investigators
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