Comparison of FemSoft® urethral insert and vaginal tampons for stress urinary incontinence

Completed

Conditions: Female stress urinary incontinence
Urological and Genital Diseases
Stress incontinence

Registration Number: ISRCTN97985616

Lead Sponsor: Rochester Medical Ltd (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 90

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Number of incontinence episodes per week (from voiding diary) whilst wearing a device<br>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 Outcome Measures

Name	Time	Method
1. Incontinence severity and bother score measured by ICI-Q SF questionnaire<br>2. Patient global assessment of improvement (post treatment only) and severity by PGI-I and PGI-S<br>3. Urgency perception scale (Cardoza et al, 2005)<br>4. Quality of life I-QoL, SF36<br>5. Patient goals <br>6. Urine microbiology (initially test strip - if positive an mid stream specimen (MSU) will be taken for culture<br>7. Secondary outcomes will be compared between groups using parametric or non-parametric tests appropriate for the types of measures