N/A
N=50
Continence Pessary Versus Disposable Intravaginal Device Trial
Female Stress Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT03174431 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Treatment Success — 8; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Continence Pessary (Device); Poise Impressa (Disposable Intravaginal Device) (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Female
- Sponsor
- Ohio State University
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Success |
8; 9 | — |
| SECONDARY Validated Questionnaires |
110; 71; 10; 7; -1; 1 | — |
| SECONDARY Satisfaction With Device |
5; 4; 7; 10; 8; 12 | — |
| SECONDARY Adverse Events |
1; 0 | — |
| SECONDARY 6 Month Follow up |
5; 4; 0; 2; 0; 1 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03174431). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.