Disposable Stress Urinary Incontinence Pessary Device Study

NCT ID: NCT03323723

Last Updated: 2019-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-16
• Study Completion Date: 2018-05-01

Brief Summary

This study is an interventional, single arm, multi-center study. It will be conducted at sites in the northeastern United States. The protocol will be approved by Chesapeake IRB or applicable local IRBs. The sample size will consist of approximately 50 participants. Participants will undergo an initial control period in which preweighed pads will be worn for 7 consecutive days for 12 hours. This will be followed by device usage for 14 consecutive days where participants will wear both device and preweighed pads simultaneously. for 12 hours.

Detailed Description

The purpose of this study is to evaluate the efficacy and safety of an over-the-counter (OTC) disposable stress urinary incontinence (SUI) pessary device. Specifically, this study will evaluate the effectiveness of the pessary device by assessing reduction in urine leakage in approximately 50 women with Stress Urinary Incontinence (SUI). Efficacy will be assessed by mean pad weight gain per hour, reduction of stress urinary incontinence events per day, and a quality of life questionnaire. The safety of the OTC SUI pessary device will be evaluated by assessing all adverse events, including the results of urinalysis, vaginal swab, and vaginal examination.

Conditions

Stress Urinary Incontinence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RS-2 SUI Device

Comparing use of device to non-treatment phase

Group Type: OTHER

SUI Device

Intervention Type: DEVICE

Pessary SUI device

Interventions

SUI Device

Pessary SUI device

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• • Provision of signed and dated informed consent form

• Literacy must be in English (able to read and understand Informed Consent)
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Female, aged >18
• Be in generally good heath as determined by the Investigator
• Have a physician diagnosis of SUI that occurred prior to or during the screening visit of this study
• Have a > 3-month history of experiencing > 3 episodes of SUI per week
• Be willing to use the investigational pessary device for the control of urinary incontinence
• Have experience with wearing a tampon
• The most recent Pap smear is normal within 36 months.

Exclusion Criteria

• • Is pregnant, or planning to become pregnant during the study

• Has been physician diagnosed with urge urinary incontinence or mixed urinary incontinence prior to or during the screening visit for this study
• Is post-partum within 3 months
• Has had an intrauterine device (IUD) placement of less than 6 months
• Has self-reported difficulty emptying her bladder;
• Has a history of Toxic Shock Syndrome (TSS) or symptoms consistent with TSS;
• Has experienced difficulty inserting or wearing an intra-vaginal device, including a tampon;
• Has had 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 participant or the outcome of the study
• Has an active urinary tract infection or vaginal infection requiring treatment
• If for any reason, the Investigator decides that the participant should not participate in the study.
• Class III Obesity (BMI> 40.0 kg/m2)
• Advanced prolapse
• Fit assessment is not successful during screening visit

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Rinovum Women's Health, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Omar Felipe Duenas Garcia, MD

Role: PRINCIPAL_INVESTIGATOR

West Virginia University Medicine

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Allegheny Health Network/East Suburban OB/GYN

Monroeville, Pennsylvania, United States

West Virginia University Medicine

Morgantown, West Virginia, United States

Countries

United States

References

Duenas-Garcia OF, Shapiro RE, Gaccione P. Safety and Efficacy of a Disposable Vaginal Device for Stress Urinary Incontinence. Female Pelvic Med Reconstr Surg. 2021 Jun 1;27(6):360-364. doi: 10.1097/SPV.0000000000000861.

Reference Type: DERIVED

PMID: 32453209 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

TP-00002

Identifier Type: -

Identifier Source: org_study_id