Disposable Stress Urinary Incontinence Pessary Device Study

NCT03323723 | Completed Results FDA Device

• 1 other identifier: TP-00002
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 3

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.

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• Percentage Reduction of Mean Pad Weight Gain (g/hr) During Treatment Phase as Compared to Baseline Phase.

  Pad weight gain (PWG) was measured by weighing used pads returned by participants and subtracting the pre-weight of that pad to obtain the total weight of leakage. The total weight of leakage was then divided by the number of hours the pad was worn by the participant to calculate the PWG/hr. The average PWG/hr for baseline was calculated by averaging the PWG/hr for the entire 7 days of the baseline phase. The average treatment PWG/hr for treatment phase was calculated by averaging the PWG/hr of the last 7 days of treatment phase. The percent change from baseline to treatment phase was then calculated. The objective was to show that PWG/hr is reduced by \>50% during treatment phase. Thus, the null hypothesis is that the mean weight gain reduction per hour is \<=50%, and the alternative is that it is \>50%, from the control period (no device) to the treatment period (women wearing the device).

  7 days of the baseline phase and 7 days of treatment phase

Secondary Outcomes (3)

• Change in Mean SUI Episodes During Treatment Phase as Compared to Baseline Phase

  7 days of baseline period and last 7 days of treatment phase

• Change in Quality of Life From Before Treatment Phase to After Treatment Phase

  Before Treatment Phase and After Treatment Phase is complete

• Adverse Events and Labs Evaluation to Determine Safety of the Device

  21 days

Study Arms (1)

RS-2 SUI Device

OTHER

Comparing use of device to non-treatment phase

Device: SUI Device

Interventions

SUI Device DEVICE

Pessary SUI device

RS-2 SUI Device

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rinovum Women's Health, Inc.: lead

Study Sites (3)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Allegheny Health Network/East Suburban OB/GYN

Monroeville, Pennsylvania, 15146, United States

Location

West Virginia University Medicine

Morgantown, West Virginia, 26501, United States

Location

Related Publications (1)

• 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.

  PMID: 32453209 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

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

Results Point of Contact

• Title: Clinical Development Manager
• Organization: Rinovum Subsidiary 2, LLC.

hwhitelam@rinovum.com

7242418932

Study Officials

• Omar Felipe Duenas Garcia, MD

  West Virginia University Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Efficacy and Safety Study, Single Group, Open Study, Open Label

Study Record Dates

• First Submitted: October 13, 2017
• First Posted: October 27, 2017
• Study Start: October 16, 2017
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: May 16, 2019
• Results First Posted: May 16, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)