Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Procter and Gamble
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
be female 18 years or older;
provide written informed consent prior to study participation and receive a signed copy;
be in generally good health as determined by the Investigator;
have a ≥ 3 month history of experiencing SUI (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 be if
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 which could impact the safety of the subject or the outcome of the study;
for any reason, the Investigator decides that the subject should not participate in the study.
Clareo Health | A Clinical Study of the Effectiveness and Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence (SUI)
