Evaluating SUI-100™, A Non-Invasive Device for the Treatment of Stress Urinary Incontinence

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.

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)