Pippa Pessary Study (Clinical Trial) (NCT05611970) | Clinical Trial Compass
TerminatedNot Applicable
Pippa Pessary Study (Clinical Trial)
Stopped: Management decision
United States7 participantsStarted 2023-02-13
Plain-language summary
This is an open label, interventional, single arm, multi-clinic study where each adult female participant with stress urinary incontinence (SUI) serves as her own control (vaginal pessary use vs. no vaginal pessary).
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female, ≥18 years of age
* Diagnosed with SUI by a physician using a cough stress test (positive test)
* Confirmed Pippa Fitness Pessary fit in clinic by a physician or qualified clinician (e.g., Nurse Practitioner, Registered Nurse)
* Have a \>3 month history of experiencing more than 3 episodes of SUI per week
* English literacy sufficient to understand the nature of the study and sufficient to read and understand the informed consent form
* Provision of a signed and dated informed consent form
* Willingness to use the Pippa Fitness Pessary during the study and comply with study procedures
* Willingness to forego use of any vaginal insert (e.g.: vaginal pessaries, bladder supports, estrogen rings, tampons, and menstrual cups) while the Pippa Fitness Pessary is in place
* Willingness to cease use of any other form of urinary incontinence treatment for the duration of the study
* Willingness and ability to interact with study staff by email, phone, text message and video conferencing software throughout study
Exclusion Criteria:
* Known urethral stricture, bladder neck contracture, spastic bladder, vesicoureteral reflux, bladder stones, and/or bladder tumors
* Concurrent bladder specific medications (including beta agonists or anticholinergics) that affect urination and the use of any other prescription medication and/or over-the-counter medication and/or dietary supplements (including herbal supplements and those taken as teas) that affect urination,…
What they're measuring
1
Proportion of Participants With Diagnosed Stress Urinary Incontinence (SUI) Who Achieved >50% Reduction of Urine Leakage With Intervention