Continence Pessary Versus Disposable Intravaginal Device Trial
- Conditions
- Female Stress Incontinence
- Registration Number
- NCT03174431
- Lead Sponsor
- Ohio State University
- Brief Summary
This is a multi-centered randomized controlled trial of women with stress urinary incontinence or stress predominant mixed urinary incontinence who desire non-surgical therapy.
- Detailed Description
In this randomized trial, eligible patients who provide written consent for participation will be enrolled. At enrollment we will collect baseline demographic data and ask participants to complete questionnaires and a 3-day bladder diary. Subjects will be randomized in a 1:1 ratio to continence pessary or disposable intravaginal device.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 50
- Age 21 years or older (based on disposable intravaginal device manufacturing recommendations).
- SUI or SUI-predominant mixed incontinence
- English-speaking
- Pregnancy
- Current symptomatic urinary tract infection (UTI).
- Postmenopausal bleeding of unknown etiology
- Neurogenic bladder
- Urinary retention (PVR >150mL obtained via bladder scan or catheterization)
- Pelvic organ prolapse past the hymen as assessed by POP-Q examination
- Inability to complete questionnaires in English or comply with study protocol
- Contraindication to pessary or disposable intravaginal device use or prior treatment or experience with either intervention.
- Prior surgery for stress urinary incontinence
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Treatment Success 4 weeks Success of stress urinary incontinence treatment is defined as a response of "very much better" or "much better" on the Patient Global Impression of Improvement (PGI-I).
- Secondary Outcome Measures
Name Time Method Adverse Events 4 weeks Potential adverse events of interest include vaginal discomfort, vaginal bleeding, vaginal infection, vaginal abrasion/laceration, and urinary tract infection (UTI)
Validated Questionnaires 4 weeks Validated questionnaire scores obtained at baseline and week 4 with all questionnaires having higher scores indicating higher level of bother:
1. Urinary Distress Inventory (UDI-6): 6 questions measuring urinary incontinence symptom bother. Scale: 0-600.
2. Incontinence Impact Questionnaire (IIQ-7): 7 questions measuring functional impact of urinary incontinence. Scale: 0-100.
3. Female Sexual Function Index (FSFI) : 19 items use a 5-point Likert scale (1-5) to assess sexual functioning in women in 6 domains (Desire, arousal, lubrication, orgasm, satisfaction, pain). Sum of each domain is multiplied by a factor ratio (0.6: desire; 0.3: arousal and lubrication; 0.4: orgasm, satisfaction, and pain) to have all domain totals on a comparable scale.
Score ranges for each domain:
1. Desire: 1.2- 6
2. Arousal, lubrication, orgasm, and pain: 0- 6
3. Satisfaction: 0.8- 6 They are then summed to derive a total FSFI score of 2- 36.Satisfaction With Device 4 weeks Satisfaction with device will be assessed using likert scale questionnaires assessing device satisfaction, ease of use, comfort, and likelihood of continued use at 4 weeks.
6 Month Follow up 6 months 6 month intervention use and satisfaction with following questions as yes or no:
1. Still using device
2. Using other SUI treatment ( pessary, physical therapy)
3. Satisfied with treatment
Trial Locations
- Locations (2)
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
University of North Carolina🇺🇸Chapel Hill, North Carolina, United States