Status:
COMPLETED
Disposable Stress Urinary Incontinence Pessary Device Study
Lead Sponsor:
Rinovum Women's Health, Inc.
Conditions:
Stress Urinary Incontinence
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This study is an interventional, single arm, multi-center study. It will be conducted at sites in the northeastern United States. The protocol will be approved by Chesapeake IRB or applicable local IR...
Detailed Description
The purpose of this study is to evaluate the efficacy and safety of an over-the-counter (OTC) disposable stress urinary incontinence (SUI) pessary device. Specifically, this study will evaluate the ef...
Eligibility Criteria
Inclusion
- • Provision of signed and dated informed consent form
- Literacy must be in English (able to read and understand Informed Consent)
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Female, aged \>18
- Be in generally good heath as determined by the Investigator
- Have a physician diagnosis of SUI that occurred prior to or during the screening visit of this study
- Have a \> 3-month history of experiencing \> 3 episodes of SUI per week
- Be willing to use the investigational pessary device for the control of urinary incontinence
- Have experience with wearing a tampon
- The most recent Pap smear is normal within 36 months.
Exclusion
- • Is pregnant, or planning to become pregnant during the study
- Has been physician diagnosed with urge urinary incontinence or mixed urinary incontinence prior to or during the screening visit for this study
- Is post-partum within 3 months
- Has had an intrauterine device (IUD) placement of less than 6 months
- Has self-reported difficulty emptying her bladder;
- Has a history of Toxic Shock Syndrome (TSS) or symptoms consistent with TSS;
- Has experienced difficulty inserting or wearing an intra-vaginal device, including a tampon;
- Has had vaginal surgery, perineal surgery, uterine surgery, or abortion (spontaneous or induced) within the past 3 months;
- Has any Screening laboratory value outside the laboratory reference range considered clinically significant by the Investigator which could impact the safety of the participant or the outcome of the study
- Has an active urinary tract infection or vaginal infection requiring treatment
- If for any reason, the Investigator decides that the participant should not participate in the study.
- Class III Obesity (BMI\> 40.0 kg/m2)
- Advanced prolapse
- Fit assessment is not successful during screening visit
Key Trial Info
Start Date :
October 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2018
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT03323723
Start Date
October 16 2017
End Date
May 1 2018
Last Update
May 16 2019
Active Locations (3)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195
2
Allegheny Health Network/East Suburban OB/GYN
Monroeville, Pennsylvania, United States, 15146
3
West Virginia University Medicine
Morgantown, West Virginia, United States, 26501