A Clinical Study to Assess the Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence
Completed · Not applicable · Has a placebo group
Conditions studied: Stress Urinary Incontinence
In brief
This study will evaluate the safety of the pessary device by objective evaluation of vaginal wall integrity and subjective assessment of comfort during in-use conditions.
Key facts
- Study ID
- NCT02160314
- Run by
- Procter and Gamble
- People needed
- 224
- Starts
- 2014-05-01
- Expected to finish
- 2015-01-01
- Last updated by the study team
- 2016-02-15
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- be female 18 years or older;
- provide written informed consent prior to study participation and been given a signed copy;
- be in generally good health as determined by the Investigator;
- have a ≥ 3 month history of experiencing Stress Urinary Incontinence (SUI) per week (self reported);
- be willing to use the pessary investigational device to control stress urinary incontinence;
- be willing to comply with study requirements and instructions;
You may not qualify if…
- are pregnant, lactating, or planning to become pregnant during the study;
- within 3 months post partum;
- intrauterine device (IUD) placement of less than 6 months;
- has self-reported difficulty emptying her bladder;
- a history of Toxic Shock Syndrome (TSS) or symptoms consistent with TSS;
- experience difficulty inserting or wearing an intra-vaginal device, including a tampon;
- 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 and could impact the safety of the subject or the outcome of the study; or
- for any reason, the Investigator decides that the subject should not participate in the study.
Where it is running
- Study Center — Chandler, Arizona, United States
Full record on ClinicalTrials.gov
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