N/A
N=145
A Clinical Study to Assess the Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence
Stress Urinary Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT02160314 ↗Enrolled (actual)
145
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Treatment-emergent Serious Adverse Event — 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- pessary (Device); Absorbent pad (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Procter and Gamble
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment-emergent Serious Adverse Event |
0; 0 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02160314). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.