Recurrent or persistent Stress Urinary Incontinence (SUI) Urological and Genital Diseases Stress incontinence
Conditions
Interventions
Participants will be randomised on a 1:1 basis using an online randomisation system or automated telephone system:
Arm 1 - endoscopic (urethral) bulking injections
Arm 2 - surgical procedure (colposus
women in the surgical operation group will decide which operation to have with their doctor
Women will receive their treatment and aftercare at hospital, as they would during normal NHS care and will
Sponsors
North Bristol NHS Trust
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Adult women (=18-years) with bothersome Stress Urinary Incontinence (SUI) symptoms after primary SUI surgery (including bulking injections) 2. Urodynamics to confirm recurrent or persistent SUI 3. Patient willing to consider interventional therapy 4. Patient willing to be randomised and willing to give consent
Exclusion criteria
Exclusion criteria: 1. Predominant urgency incontinence 2. Pelvic organ prolapse (POP) more than or equal to stage II 3. Relevant neurological disease, disease, such as a stroke, multiple sclerosis, Parkinson’s disease, or spina bifida (diabetes mellitus is not an exclusion criterion unless it is causing diabetic neuropathy) 4. Being treated for gynaecological or bladder cancer 5. Unresolved mesh exposure from previous midurethral tape (MUT) 6. Current pregnancy 7. Urethral diverticulum 8. Recent pelvic surgery (e.g. POP repair, stress incontinence surgery, and hysterectomy within the last 6-months) 9. Participation in another study that might influence results or increase patient burden 10. Unable to give informed consent/complete assessments 11. Previous artificial urinary sphincter (AUS) surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient-reported outcome measure (PROM) of continence using the International Consultation on Incontinence Questionnaire - Urinary Incontinence - Short Form (ICIQ-UI-SF) at 1 year after randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical subjective measure of continence (longer term) using the ICIQ-UI-SF questionnaire at 6 months, 2 and 3 years post randomisation 2. Improvement of symptoms measured using the Patient Global Impression of Improvement (PGI-I) questionnaire at 1, 2 and 3 years post randomisation 3. Procedure/operative assessment measures: assessment of procedure/operation time, estimated blood loss, hospital stay, and return to normal activity, measured at time of intervention and at 6 months post-intervention 4. Incontinence and sexual function assessed using the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire (PISQ-IR) at 1, 2 and 3 years post randomisation 5. Adverse events: evaluation of treatment and retreatment, adverse events of each intervention at intervention, 6 months post intervention, and 6 months, 1, 2 and 3 years post randomisation 6. Cost-effectiveness from an NHS and societal perspective in terms of Quality-Adjusted Life Years (QALYs) and ICIQ-UI-SF at 1 year, and from a secondary care NHS perspective in terms of QALYs at 3 years. EQ-5D-5L (used to calculate QALYs) questionnaire at 6 months, 1, 2 and 3 years post-randomisation. Secondary care resource use from Trust electronic systems (or Hospital Episode Statistics) at 1 and 3 years post-randomisation. Community-based and patient resource use questionnaire at 6 months and 1 year post-randomisation 7. Patient experiences of the intervention, assessed using qualitative interviews with patients at 6 months, 1 year and 3 years post-intervention 8. Clinician views of the intervention, assessed using qualitative interviews with clinicians around baseline | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactCaroline Pope
Outcome results
None listed