N/A N=83 Treatment

A Pilot Clinical Study of the Efficacy and Safety of a Disposable Intravaginal Device for Stress Urinary Incontinence

Stress Urinary Incontinence

Bottom Line

View on ClinicalTrials.gov: NCT01762345 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2016

Primary outcome: Primary: Change in Pad Weight Gain — 2.67 grams/usage period

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: pessary (disposable intra-vaginal device) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Procter and Gamble
Primary completion: Jul 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Pad Weight Gain	2.36	—
PRIMARY Change in Stress Urinary Incontinence Episodes	0.65	—
SECONDARY Change in Pad Weight Gain	2.36	—
SECONDARY Change in Stress Urinary Incontinence Episodes	0.65	—
SECONDARY Change in Quality of Life as Measured by Incontinence Impact Questionnaire (IIQ-7)	9.52	—

Summary

This pilot study will evaluate the efficacy of the pessary (disposable intra-vaginal device) by reduction in urine leakage in women with stress urinary incontinence (SUI).

Eligibility Criteria

Inclusion Criteria

have a ≥ 3 month history of experiencing Stress Urinary Incontinence
be willing to use the pessary investigational device to control stress incontinence

Exclusion Criteria

pregnant, lactating or planning to become pregnant during the study
within 3 months post partum
intrauterine device (IUD) placement of less than 6 months
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
for any reason, the Investigator decides that the subject should not participate in the study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01762345). 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.