Clinical trial NCT03978741: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: Watkins Conti Products. Inc.
Sponsor class: INDUSTRY
First posted: 2019-06-07
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Responder rate at Day 21
timeFrame: 21 Days
Secondary outcomes:
measure: Percent Change in mean pad weight
timeFrame: 7 Days, 14 Days
measure: Percent change in the frequency of SUI events per the patient diary
timeFrame: 7 Days, 14 Days
measure: Responder rate for frequency of SUI events per the patient diary at Day 21,
timeFrame: 21 Days
measure: Percent change in Incontinence Impact Questionnaire (IIQ-7) score
timeFrame: 21 Days
measure: Percent change in Patient Global Impression of Change (PGIC) score
timeFrame: 21 Days
measure: Percent change in Incontinence-Quality of Life (I-QOL) Assessment Questionnaire
timeFrame: 21 Days
measure: Ease of use per the USE Questionnaire: Usefulness, Satisfaction, and Ease of Use
timeFrame: 21 Days
measure: Ease of use per the USE Questionnaire: Satisfaction
timeFrame: 21 Days
measure: Ease of use per the USE Questionnaire:Ease of Use
timeFrame: 21 Days
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
affiliation: Watkins Conti Products. Inc.
name: Allsion Watkins-Conti
role: STUDY_DIRECTOR
References: