Stress urinary incontinence Urological and Genital Diseases Urinary incontinence
Conditions
Interventions
This is a pilot single centre un-blinded randomised controlled trial with a 12 month follow-up. Randomisation is independently prepared numbered opaque sealed envelopes stored independently from the t
Sponsors
University of Aberdeen
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women aged over 18 years 2. Urodynamic stress incontinence 3. Failed conservative treatment 4. Being offered surgery
Exclusion criteria
Exclusion criteria: 1. Not prepared to accept surgery 2. Requiring additional prolapse surgery 3. Undergone previous surgery for stress urinary incontinence 4. Not completed their families, i.e., will still want children 5. Unable or unwilling to give informed consent 6. Unwilling to participate in follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Changes in International Consultation on Incontinence Questionnaire (ICIQ), assessed at baseline 2. Differences in quality adjusted life years (QALYs) estimated from responses to the EQ-5D, measured at baseline and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Subjective cure rate 2. Changes in the King's Health questionnaire (KHQ) scores 3. Difference in EQ-5D scores at three and twelve months follow-up 4. Operative data 5. Self-reported acceptability 6. Usage recommendation to a friend All measured at baseline, two weeks (except for the EQ-5D), three months and twelve months. | — |
Countries
United Kingdom
Outcome results
None listed