Overview
The goal of this pivotal clinical trial is to evaluate the safety and effectiveness of the SUI-100 device for the treatment of mild-to-moderate stress urinary incontinence (SUI) in females aged 22-70 years.
The main questions this study aims to answer are:
- Does treatment with the SUI-100 device reduce SUI symptoms, as measured by urine leakage.
- Is the device safe and effective compared to the sham group?
Participants will:
- Be randomly assigned to an active or sham control group in a blinded, multicenter study.
- Attend treatment visits during the Treatment Phase, with SUI assessments conducted at specific intervals.
- Enter a 3-month, treatment-free follow-up phase, with SUI assessment.
- Proceed to three monthly maintenance treatments, followed by a final SUI assessment at study exit.
The total study duration will last approximately 18 months, with each individual's participation lasting approximately 6-8 months. This study aims to provide robust data on the effectiveness, safety, and durability of the SUI-100 device for treating female Stress Urinary Incontinence.
Description
Stress urinary incontinence, characterized by the involuntary loss of urine during activities that increase intra-abdominal pressure, affects approximately 50% of women with urinary incontinence and significantly impacts their quality of life. The SUI-100 device offers a novel, low-risk alternative to existing treatments, addressing a critical need for effective and conservative options.
Study Design:
The trial employs a randomized, blinded, sham-controlled, multi-center approach with an option for cross-over for participants randomized to sham.
Study Aim:
The study aims to determine the safety and efficacy of the study product in treating SUI. The study device is non-surgical and non-invasive.
Primary and Secondary Outcomes:
The study's primary objective is to determine whether treatment with the device reduces urine leakage by ≥50%, as measured by the 24-Hour Pad Weight Test, compared to the sham arm.
Safety Monitoring:
Safety assessments will be conducted throughout the study, with all adverse events (AEs) and adverse device effects (ADEs) documented and graded for severity.
Key Distinctions:
This trial is unique in its use of a non-invasive device that may offer a low-risk alternative to invasive treatments like urethral slings and radiofrequency therapy. The study's design, incorporating a sham-controlled, blinded methodology, ensures rigorous evaluation of the device's efficacy and safety.
Eligibility
Inclusion Criteria:
- Females aged 22-70 years
- MESA-UIQ SUI score must exceed MESA-UIQ UUI score
- Investigator diagnosis of SUI at Baseline Study Visit A
- µ-24-PWT >10 grams, and ≤74 grams
- Positive PST (observed urine loss during coughing or Valsalva maneuver)
- Able to independently read and willing to provide written informed consent and comply with all study visits and assessments required by study protocol
- Able to independently read and complete all questionnaires and diaries provided in English
- Negative urine test for urinary tract infection (UTI)
- Negative urine test for pregnancy
- Willing to use physician-approved contraception and avoid pregnancy for the duration of the study period if of child-bearing potential. An oral contraceptive may be started at study enrollment. Intrauterine device (IUD) is allowed if placed prior to study participation and not removed during the study.
- Agrees not to participate in any other clinical research study(s) during this study
- Willing to maintain same dose for any urge urinary incontinence (UUI) medications during study
- If taking any of the following medications (may not start during trial); oral or vaginal estrogen therapy or other medication known to affect incontinence, such as testosterone, growth hormones, alpha-blockers, sedative-hypnotics, antipsychotics, angiotensin-converting enzyme (ACE) inhibitors, loop diuretics, and calcium channel blockers, must be stable for 3 months prior, and willing to maintain same dose throughout trial
Exclusion Criteria:
- Body Mass Index (BMI) >35
- µ-24-PWT ≥ 75 grams
- Subject is non-ambulatory
- Inability to maintain the low lithotomy position in a relaxed manner for the duration of the treatment delivery during visit
- Subject has any electrical or electromagnetic implanted medical devices
- History of UUI or mixed incontinence with a predominant urge component
- History of incontinence of neurogenic etiology
- Subject is pregnant or <12-months post-partum
- Pelvic organ prolapse (POP) (e.g., greater than Stage 2 as defined by the International Continence Society (e.g., cystocele, rectocele)
- PVR urine test volume >150 mL
- Prior treatments for SUI:
- Any SUI surgery (e.g., slings)
- Bulking agent injection within 1 year
- Electrostimulation or magnetic stimulation within 3 months
- Pessary or urethral plug unless removed at least two weeks prior to start of study
- Physical therapy or pelvic floor exercises, such as Kegel exercises, to strengthen pelvic floor muscles and urinary sphincter within the past 60 days
- Diagnosis of pelvic pain
- History of radiation to the pelvis
- Any recent pelvic surgery (within 1 year)
- History of bladder stone
- History of interstitial cystitis
- History of dyspareunia or external vaginal pain syndromes such as vulvodynia
- Hematuria
- Neurological diseases known to affect the bladder
- Conditions posing additional risks:
- Bleeding disorder or currently taking anticoagulants
- Current urinary infection - positive urine culture, signs of urinary infection; may repeat inclusion criteria urinary analysis (UA) after the UTI has been successfully resolved with a full course of antibiotics and a report UA is negative
- History of cervical, uterine, bladder, urethral, or rectal cancer
- Genital warts, lesions, or sexually transmitted disease that are locally visible
- Currently undergoing any incontinence treatment
- Concurrent enrollment in another clinical trial
- Not suitable for the study or is at risk of study non-compliance in the judgement of the Principal Investigator (PI)