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

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02160314
• Other study ID #: 2012119
• Status: Completed
• Phase: N/A
• First received: June 4, 2014
• Last updated: January 15, 2016
• Start date: May 2014
• Est. completion date: January 2015

Study information

• Verified date: January 2016
• Source: Procter and Gamble
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• pessary
disposable, single-use pessary
• Absorbent pad

Locations

Country	Name	City	State
United States	Study Center	Chandler	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Procter and Gamble

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment-emergent Serious Adverse Event	proportion of intent-to-treat subjects who experience a treatment-emergent serious adverse event	3 month	Yes