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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-03

Study Completion Date

2022-08-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Feasibility Device Study to Prevent Female Urinary Stress Incontinence

NCT03010800

Stress Incontinence, Female

COMPLETED NA

TVT-SECUR A Pilot Study for the Treatment of Stress Urinary Incontinence

NCT00463554

Stress Urinary Incontinence

COMPLETED

Weighted Vaginal Cones Versus Biofeedback in the Treatment of Urodynamic Stress Incontinence: a Randomized Trial.

NCT00247286

Urinary Incontinence, Stress

TERMINATED PHASE4

Comparison of Two Over the Counter Intravaginal Devices for the Treatment of Stress Urinary Incontinence

NCT06698627

Stress Urinary Incontinence in Women

ENROLLING_BY_INVITATION NA

The AttenueX IntraVesical System for the Treatment of Female Stress Urinary Incontinence

NCT00492596

Urinary Incontinence, Stress

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Urinary Incontinence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Test Device

Yōni.Fit Test Device

Group Type EXPERIMENTAL

Yōni.Fit Test Device

Intervention Type DEVICE

The Yōni.Fit Test Device is a silicone pessary.

Comparator Device

Yōni.Fit Comparator Device

Group Type ACTIVE_COMPARATOR

Yōni.Fit Comparator Device

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Yōni.Fit Test Device

The Yōni.Fit Test Device is a silicone pessary.

Intervention Type DEVICE

Yōni.Fit Comparator Device

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No