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

Watkins-Conti Products

Status: Completed

Conditions: Urinary Incontinence

Treatments: Device: Yōni.Fit Comparator Device; Device: Yōni.Fit Test Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT03978741

18-02041

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Test Device

Experimental group

Description:

Yōni.Fit Test Device

Treatment:

Device: Yōni.Fit Test Device

Comparator Device

Active Comparator group

Description:

Yōni.Fit Comparator Device

Treatment:

Device: Yōni.Fit Comparator Device