Study Evaluating the Efficacy and Safety of Yoni.Fit in Women With Stress Urinary Incontinence

NCT03978741 | Completed FDA Device

• 1 other identifier: 18-02041
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief Summary

Study to evaluate the safety and effectiveness of Yoni.Fit for the temporary management of stress urinary incontinence (SUI) in women.

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• Responder rate at Day 21

  Responder rate at Day 21, where responder is defined as a subject who has at least 50% reduction in mean 12-hour pad weight test through assessment period of treatment phase (the last 7 days of 14-day device usage period), when compared to the mean pad weight test during the 7-day baseline phase

  21 Days

Secondary Outcomes (9)

• Percent Change in mean pad weight

  7 Days, 14 Days

• Percent change in the frequency of SUI events per the patient diary

  7 Days, 14 Days

• Responder rate for frequency of SUI events per the patient diary at Day 21,

  21 Days

• Percent change in Incontinence Impact Questionnaire (IIQ-7) score

  21 Days

• Percent change in Patient Global Impression of Change (PGIC) score

  21 Days

Study Arms (2)

Test Device

EXPERIMENTAL

Yōni.Fit Test Device

Device: Yōni.Fit Test Device

Comparator Device

ACTIVE COMPARATOR

Yōni.Fit Comparator Device

Device: Yōni.Fit Comparator Device

Interventions

Yōni.Fit Test Device DEVICE

The Yōni.Fit Test Device is a silicone pessary.

Test Device

Yōni.Fit Comparator Device DEVICE

The Yōni.Fit Comparator Device is a silicone pessary with a different configuration.

Comparator Device

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be female,
• Must be 18 years of age or older at the time of signing the informed consent
• With BMI \< 35
• Must meet the following 2 criteria for diagnosis of stress urinary incontinence (SUI) :
• SUI clinical diagnosis via the cough supine test, AND
• ≥ 3 month history of experiencing Stress Urinary Incontinence (SUI) symptoms per the patient
• Women of childbearing potential not intending to become pregnant for the duration of study participation. Subject must agree for the duration of the study to use one of the following forms of contraception
• Systemic hormonal treatment including oral pills, patches and injections OR
• "Single-barrier" contraception (condom, diaphragm and spermicide are each considered a barrier) OR
• Essure® procedure done at least three month prior to screening
• Willing to comply with study requirements, including capable of performing the activities required for the pad weight test and return for follow-up visits.
• Must be able to speak, understand and read English and sign study specific Informed Consent Form

You may not qualify if:

• Women having predominantly urge or mixed incontinence as defined by:
• QUID Urge score \>6, OR
• MESA percentage Urge Score \> MESA percentage Stress Score Note: the questionnaires above will be self-administered and results interpreted by the subjects as per instructions in the questionnaires.
• Current pregnancy, lactation or planning for pregnancy in the next 6 months
• Women at postpartum for 3 months or less prior to screening
• Women currently have an intrauterine device (IUD) as a contraception method placement less than 6 months or have an IUD over 6 month but may replace it next 14 weeks
• Women currently use, have used an intra-vaginal device as contraception method for the past 6 months
• Women currently using a pessary or treated previously with any device for UI
• Women who have been treated with pharmacologic medications for UI within the past 4 months prior to screening, including any antidiuretic or diuretic medications (both over the counter and prescription medications)
• Women who have been previously treated with any surgical or electrical interventions for UI
• Women who have been previously treated with pelvic floor muscle training (PFMT) for UI within the past 4 months prior to screening
• Women who have difficulty inserting or wearing an intra-vaginal device, including a tampon
• Women who participated in a clinical trial within the 12 months prior to screening
• Any of the following known conditions deemed prohibitory:
• Abnormal kidney function, including kidney stone

Sponsors & Collaborators

• Watkins Conti Products. Inc.: lead

Study Sites (3)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

• Escobar C, Sokol ER, Rosenblum N, Milikien D, Echols K. A Randomized Controlled Trial of a Novel Device for Stress Incontinence. Urogynecology (Phila). 2025 Apr 28. doi: 10.1097/SPV.0000000000001676. Online ahead of print.

  PMID: 40288810 DERIVED

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

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

Study Officials

• Allsion Watkins-Conti

  Watkins Conti Products. Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: June 7, 2019
• Study Start: January 3, 2020
• Primary Completion: May 5, 2022
• Study Completion: August 26, 2022
• Last Updated: May 8, 2023

Record last verified: 2023-05

Locations

US (3)