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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Continence pessaries are inexpensive, reusable intravaginal devices made of flexible silicon that provide support to the urethra to prevent urinary leakage. Continence pessaries are fitted by trained clinicians in the office and managed by patients or their provider.
In 2014, the FDA approved an over-the-counter disposable intravaginal device as another nonsurgical treatment for SUI. This device is comprised of 4 support poles covered in a non-absorbable nylon mesh that is deployed using an intravaginal applicator.
University of North Carolina
Chapel Hill, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
Treatment Success
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).
Time frame: 4 weeks
Validated Questionnaires
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.
Time frame: 4 weeks
Satisfaction With Device
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.
Time frame: 4 weeks
Adverse Events
Potential adverse events of interest include vaginal discomfort, vaginal bleeding, vaginal infection, vaginal abrasion/laceration, and urinary tract infection (UTI)
Time frame: 4 weeks
6 Month Follow up
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
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Time frame: 6 months