Female stress urinary incontinence Urological and Genital Diseases Stress incontinence
Conditions
Interventions
Eligible participants will be assigned to a treatment group using computer generated randomisation in blocks, with allocation from a central office. Either device will be used, firstly for a training
Sponsors
Rochester Medical Ltd (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female participants over 18 years of age 2. Not pregnant and if of child-bearing age agrees to use reliable contraception throughout the trial 3. Able and willing to use tampons 4. Sufficient mobility / dexterity to use device and competent mentally 5. Able to give consent 6. Confirmed moderate to severe (at least one episode per day on average) SUI or mixed incontinence that is SUI predominant (cough test or urodynamic assessment) 7. Period of trial representative of normal activities (e.g. does not include a holiday)
Exclusion criteria
Exclusion criteria: 1. Body mass index (BMI) > 40 2. Previous surgery for SUI 3. Pelvic organ prolapse (POP) > stage 2 4. Using medication to treat urinary incontinence such as anticholinergics or duloxetine 5. History of recurrent urinary tract infections or signs and symptoms of a urinary tract infection 6. Signs and symptoms of vaginal / urethral irritations 7. Post residual volumes greater than 200 ml 8. Unable to understand instructions for use of the device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Number of incontinence episodes per week (from voiding diary) whilst wearing a device 2. The primary outcome will be compared between the two groups in two ways - number of episodes (either with appropriate non-parametric tests or generalised linear models, since incontinence episodes typically follow a Poisson distribution), and a separate comparison of subjects reporting no episodes that is those reporting continence whilst using the device (if there are sufficient of these) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incontinence severity and bother score measured by ICI-Q SF questionnaire 2. Patient global assessment of improvement (post treatment only) and severity by PGI-I and PGI-S 3. Urgency perception scale (Cardoza et al, 2005) 4. Quality of life I-QoL, SF36 5. Patient goals 6. Urine microbiology (initially test strip - if positive an mid stream specimen (MSU) will be taken for culture 7. Secondary outcomes will be compared between groups using parametric or non-parametric tests appropriate for the types of measures | — |
Countries
United Kingdom
Outcome results
None listed