Continence Pessary Versus Disposable Intravaginal Device Trial
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|ClinicalTrials.gov Identifier: NCT03174431|
Recruitment Status : Unknown
Verified June 2017 by Silpa Nekkanti, Ohio State University.
Recruitment status was: Not yet recruiting
First Posted : June 2, 2017
Last Update Posted : June 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Female Stress Incontinence||Device: Continence Pessary Device: Poise Impressa (Disposable Intravaginal Device)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Comparison of Continence Pessary to a Disposable Intravaginal Device in the Management of Stress Urinary Incontinence: A Randomized Controlled Trial|
|Estimated Study Start Date :||June 15, 2017|
|Estimated Primary Completion Date :||June 1, 2019|
|Estimated Study Completion Date :||August 1, 2019|
Active Comparator: 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.
Device: Continence Pessary
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.
Active Comparator: 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.
Device: Poise Impressa (Disposable Intravaginal Device)
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.
Other Name: Poise Impressa
- Treatment success [ Time Frame: 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).
- Change in stress urinary incontinence episodes [ Time Frame: 4 weeks ]Change in stress urinary incontinence episodes recorded on a 3-day bladder diary, comparing baseline to end of study
- Quality of life questionnaire change scores [ Time Frame: 4 weeks ]Questionnaire change scores (from baseline to 4 weeks) on validated questionnaires
- Satisfaction with device [ Time Frame: 4 weeks ]Satisfaction with device will be assessed using likert scale questionnaires assessing device satisfaction, ease of use, comfort, and likelihood of continued use.
- Adverse events [ Time Frame: 4 weeks ]Potential adverse events of interest include vaginal discomfort, vaginal bleeding, vaginal infection, vaginal abrasion/laceration, and urinary tract infection (UTI)
- Cost [ Time Frame: 4 weeks ]Cost calculations will include cost of sizing kit and devices for the disposable intravaginal device and the cost of the device, initial fitting visit and any additional clinic visits for the continence pessary.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03174431
|Contact: Silpa Nekkanti, MDemail@example.com|
|Contact: Alexis Dieter, MDfirstname.lastname@example.org|