A Clinical Study to Assess the Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence

A Clinical Study to Assess the Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence

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.

Inclusion Criteria:

• 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;

Exclusion Criteria:

• 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.