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

NCT02160314 | Completed Results

• 1 other identifier: 2012119
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stress Urinary Incontinence

Keywords

stress urinary incontinence, SUI, pessary

Outcome Measures

Primary Outcomes (1)

• Treatment-emergent Serious Adverse Event

  proportion of intent-to-treat subjects who experience a treatment-emergent serious adverse event

  3 month

Study Arms (2)

pad

PLACEBO COMPARATOR

absorbent pad control

Device: Absorbent pad

pessary

EXPERIMENTAL

disposable, single-use pessary

Device: pessary

Interventions

pessary DEVICE

disposable, single-use pessary

pessary

Absorbent pad DEVICE

Also known as: placebo comparator

pad

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Procter and Gamble: lead

Study Sites (1)

Study Center

Chandler, Arizona, 85224, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Pessaries; Absorbent Pads

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies; Equipment and Supplies, Hospital

Results Point of Contact

• Title: Mylissa Trowbridge
• Organization: Procter & Gamble Company Global Clinical Sciences

trowbridge.mm@pg.com

Study Officials

• Randall Severance, MD

  Radiant Research, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2014
• First Posted: June 10, 2014
• Study Start: May 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: February 15, 2016
• Results First Posted: February 15, 2016

Record last verified: 2016-01

Locations

US (1)