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

• ClinicalTrials.gov Identifier: NCT03978741
• Recruitment Status: Recruiting
• First Posted: June 7, 2019
• Last Update Posted: August 18, 2020
• Sponsor: Watkins Conti Products. Inc.
• Information provided by (Responsible Party): Watkins Conti Products. Inc.

Tracking Information

• First Submitted Date: May 8, 2019
• First Posted Date: June 7, 2019
• Last Update Posted Date: August 18, 2020
• Actual Study Start Date: January 3, 2020
• Estimated Primary Completion Date: June 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 5, 2019)

Responder rate at Day 21 [ Time Frame: 21 Days ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 5, 2019)

• Percent Change in mean pad weight [ Time Frame: 7 Days, 14 Days ]
  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
• Percent change in the frequency of SUI events per the patient diary [ Time Frame: 7 Days, 14 Days ]
  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
• Responder rate for frequency of SUI events per the patient diary at Day 21, [ Time Frame: 21 Days ]
  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
• Percent change in Incontinence Impact Questionnaire (IIQ-7) score [ Time Frame: 21 Days ]
  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.
• Percent change in Patient Global Impression of Change (PGIC) score [ Time Frame: 21 Days ]
  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").
• Percent change in Incontinence-Quality of Life (I-QOL) Assessment Questionnaire [ Time Frame: 21 Days ]
  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 .
• Ease of use per the USE Questionnaire: Usefulness, Satisfaction, and Ease of Use [ Time Frame: 21 Days ]
  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."
• Ease of use per the USE Questionnaire: Satisfaction [ Time Frame: 21 Days ]
  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."
• Ease of use per the USE Questionnaire:Ease of Use [ Time Frame: 21 Days ]
  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."

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study Evaluating the Efficacy and Safety of Yoni.Fit in Women With Stress Urinary Incontinence
• Official Title: Randomized, Comparator-controlled, Single Blinded, Multi-center Study Evaluating the Efficacy and Safety of Yoni.Fit in Women With Stress Urinary Incontinence
• Brief Summary: Study to evaluate the safety and effectiveness of Yoni.Fit for the temporary management of stress urinary incontinence (SUI) in women.
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Urinary Incontinence

Intervention

• Device: Yōni.Fit Test Device
  The Yōni.Fit Test Device is a silicone pressary.
• Device: Yōni.Fit Comparator Device
  The Yōni.Fit Comparator Device is a silicone pressary.

Study Arms

• Experimental: Test Device
  Yōni.Fit Test Device
  Intervention: Device: Yōni.Fit Test Device
• Active Comparator: Comparator Device
  Yōni.Fit Comparator Device
  Intervention: Device: Yōni.Fit Comparator Device

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 5, 2019): 48
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2021
• Estimated Primary Completion Date: June 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Participants must be female,
2. Must be 18 years of age or older at the time of signing the informed consent
3. With BMI < 35

4. Must meet the following 2 criteria for diagnosis of stress urinary incontinence (SUI) :

   1. SUI clinical diagnosis via the cough supine test, AND
   2. ≥ 3 month history of experiencing Stress Urinary Incontinence (SUI) symptoms per the patient

5. 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

   1. Systemic hormonal treatment including oral pills, patches and injections OR
   2. "Single-barrier" contraception (condom, diaphragm and spermicide are each considered a barrier) OR
   3. Essure® procedure done at least three month prior to screening
6. Willing to comply with study requirements, including capable of performing the activities required for the pad weight test and return for follow-up visits.
7. Must be able to speak, understand and read English and sign study specific Informed Consent Form

Exclusion Criteria:

1. Women having predominantly urge or mixed incontinence as defined by:

   1. QUID Urge score >6, OR
   2. 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.
2. Current pregnancy, lactation or planning for pregnancy in the next 6 months
3. Women at postpartum for 3 months or less prior to screening
4. 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
5. Women currently use, have used an intra-vaginal device as contraception method for the past 6 months
6. Women currently using a pessary or treated previously with any device for UI
7. 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)
8. Women who have been previously treated with any surgical or electrical interventions for UI
9. Women who have been previously treated with pelvic floor muscle training (PFMT) for UI within the past 4 months prior to screening
10. Women who have difficulty inserting or wearing an intra-vaginal device, including a tampon
11. Women who participated in a clinical trial within the 12 months prior to screening

12. Any of the following known conditions deemed prohibitory:

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 100 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Dominique Malacarne Pape, MD; 646-825-6300; Dominique.Malacarne@nyulangone.org

Contact: Christine Escobar, MD; 646-825-6300; Christina.Escobar@nyulangone.org

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03978741
• Other Study ID Numbers: 18-02041
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Watkins Conti Products. Inc.
• Study Sponsor: Watkins Conti Products. Inc.
• Collaborators: Not Provided

Investigators

• Principal Investigator: Dominique Malacarne Pape, MD; New York Langone Medical Center

• PRS Account: Watkins Conti Products. Inc.
• Verification Date: August 2020