AzTrials
AzTrials

Urinary IncontinenceNCT03978741

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

A study testing Yōni.Fit Test Device and Yōni.Fit Comparator Device in people with Urinary Incontinence, run by Watkins Conti Products. Inc. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 100 years, women only
Conditions the study is for
Urinary Incontinence
What is being tested?
Yōni.Fit Test Device and Yōni.Fit Comparator Device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
3 sitesUnited States
Study dates
3 Jan 2020to 26 Aug 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • 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
Show all 32Show fewer
  • 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
  • Abnormal post void residual (e.g. greater than 150cc) or self-reported difficulty emptying bladder
  • Allergy to silicon products and materials
  • Acute febrile illness of any cause in the 14 days prior to screening
  • Bladder stones or Bladder tumors
  • Chronic pelvic pain within the past 4 months prior to screening
  • Coagulation abnormalities
  • Experience pain or burning sensation during sexual intercourse or urination
  • Infections of the vagina, bladder and/or urethra within previous 3 months such as urinary tract infection (UTI)
  • Interstitial cystitis
  • Neurological disorders such as multiple sclerosis, spina bifida, Parkinson's disease which may interfere with nerve function of the bladder.
  • Toxic shock syndrome (TSS) history or symptoms consistent with TSS
  • Uncontrolled diabetes
  • Undiagnosed vaginal bleeding or hematuria
  • Vaginal discharge with a strong odor and irritation within previous 3 months
  • Vaginal soreness or pain or fibromyalgia or paravaginal defect
  • Any other medical reason that the Investigator determines that the subject should not participate in the study
  • Known history of previous pelvic organ prolapse greater than the POP-Q Stage 2 as defined by the international continence society (ICS).

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • NYU Langone Health

    New York, New York, 10016

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Stanford University School of Medicine

    Stanford, California, 94305

Other trials in United States

About this study

Official title: Randomized, Comparator-controlled, Single Blinded, Multi-center Study Evaluating the Efficacy and Safety of Yoni.Fit in Women With Stress Urinary Incontinence

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

Read the detailed description

Randomized, comparator-controlled, single blinded, multicenter study to demonstrate the effectiveness, user acceptance, safety and tolerability of Yoni.Fit in the temporary management of stress urinary incontinence (SUI) in women.

Being tested
Yōni.Fit Test Device, Yōni.Fit Comparator Device
Medical subject headings
Urinary Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Yōni.Fit Test DeviceDevice

    The Yōni.Fit Test Device is a silicone pessary.

  • Yōni.Fit Comparator DeviceDevice

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

Study groups in NCT03978741
Study groupRoleWhat they receive
Test DeviceExperimentalYōni.Fit Test Device
Receives: Device: Yōni.Fit Test Device
Comparator DeviceActive comparatorYōni.Fit Comparator Device
Receives: Device: Yōni.Fit Comparator Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 21 Days

Secondary outcomes (9)

  1. Percent Change in mean pad weight

    Percent change in mean pad weight during assessment period of treatment phase (the last 7 days of 14-day device usage period), from the mean pad weight during the 7-day baseline phase

    Measured: 7 Days, 14 Days

  2. Percent change in the frequency of SUI events per the patient diary

    Percent change in the frequency of SUI events per the patient diary, defined as average number of incontinence episodes per 12 hours during assessment period of treatment phase (the last 7 days of 14-day device usage period), from the average of baseline phase

    Measured: 7 Days, 14 Days

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

    Where responder is defined as a subject who has at least 50% reduction in the number of incontinence episodes per day during the last 7 days of

    Measured: 21 Days

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

    7 questions about how urinary incontinence has affected a subjects life. Questions cover physical activity, travel, social relationships and emotional health. The questionnaire asks whether the subjects life has been greatly affected, moderately, slightly or not affected at all.

    Measured: 21 Days

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

    It gives a patient reported assessment of change after intervention. The higher the score, the greater the severity (1 being "very much improved"; 7 "very much worse").

    Measured: 21 Days

  6. Percent change in Incontinence-Quality of Life (I-QOL) Assessment Questionnaire

    The I -QOL consists of 22 items, all of which use a five - point ordinal response scale in which 1 = extremely, 2 = quite a bit, 3 = moderately, 4 = a little, and 5 = not at all. The 22 items can be further grouped into 3 sub-scales: Avoidance and Limiting Behaviour (8 ite ms), Psychosocial Impacts (9 items), and Social Embarrassment (5 items). The total I -QOL and 3 sub scale scores are calculated by summing the unweighted item score and transforming them to a 100 point scale where 0 = mo st severe, and 100 = no problem .

    Measured: 21 Days

  7. Ease of use per the USE Questionnaire: Usefulness, Satisfaction, and Ease of Use

    The USE questionnaire is meant to be used to assess the Subjective reactions to the usability of the Yōni.Fit ® device. The "Usefulness" section of the questionnaire consists of 19 questions regarding usability of the device scaled from 1- "strongly disagree" to 7- "strongly agree."

    Measured: 21 Days

  8. Ease of use per the USE Questionnaire: Satisfaction

    The USE questionnaire is meant to be used to assess the Subjective reactions to the usability of the Yōni.Fit ® device. The "Usefulness" section of the questionnaire consists of 7 questions regarding Satisfaction with the device scaled from 1-"strongly disagree" to 7-"Strongly Agree."

    Measured: 21 Days

  9. Ease of use per the USE Questionnaire:Ease of Use

    The USE questionnaire is meant to be used to assess the Subjective reactions to the usability of the Yōni.Fit ® device. The "Usefulness" section of the questionnaire consists of 11 questions regarding Ease of Use with the device scaled from 1-"strongly disagree" to 7-"Strongly Agree."

    Measured: 21 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2019
  2. Study start3 Jan 2020
  3. Primary completion5 May 2022
  4. Study completion26 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03978741
Sponsor's protocol ID
18-02041
Status last verified
May 2023
First submitted
8 May 2019
Last updated
8 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Escobar C, Sokol ER, Rosenblum N, Milikien D, Echols K. A Randomized Controlled Trial of a Novel Device for Stress Incontinence. Urogynecology (Phila). 2026 Feb 1;32(2):105-115. doi: 10.1097/SPV.0000000000001676.

    PubMed 40288810

Questions about this trial

What is this clinical trial studying?

A study testing Yōni.Fit Test Device and Yōni.Fit Comparator Device in people with Urinary Incontinence, run by Watkins Conti Products. Inc. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Responder rate at Day 21 (time frame: 21 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03978741, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in