Continence Pessary Versus Disposable Intravaginal Device Trial

Not Applicable

Completed

Conditions: Female Stress Incontinence

Interventions: Device: Continence Pessary
Device: Poise Impressa (Disposable Intravaginal Device)

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

Inclusion Criteria

Age 21 years or older (based on disposable intravaginal device manufacturing recommendations).
SUI or SUI-predominant mixed incontinence
English-speaking

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Continence Pessary	Continence Pessary	Participants randomized to the continence pessary will be fitted for a pessary by a clinician at enrollment and they will be taught how to remove and reinsert the device. Per usual clinical practice they will be instructed to call with any concerns and scheduled for a return visit in 2 weeks for a follow-up to assess fit and comfort and undergo refitting if necessary.
Disposable Intravaginal Device	Poise Impressa (Disposable Intravaginal Device)	Participants randomized to the intravaginal device will be given a sizing kit in the office, asked to select a size and provided with a 2-week supply of the appropriately sized devices. In accordance with manufacturer guidelines, participants will be instructed that the device is to be used for no more than 8 hours per 24-hour period and that each device is single use only. Participants will return in 2 weeks for a follow-up visit to assess fit and comfort, undergo resizing as necessary and receive an additional 2 week supply of the appropriately sized devices.

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