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

Pivotal Study of the SUI-100™ for the Treatment of Stress Urinary Incontinence (SUI): A Nonsignificant Risk (NSR) Device (SaHARA) Study

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:

1. Does treatment with the SUI-100 device reduce SUI symptoms, as measured by urine leakage.
2. Is the device safe and effective compared to the sham group?

Participants will:

1. Be randomly assigned to an active or sham control group in a blinded, multicenter study.
2. Attend treatment visits during the Treatment Phase, with SUI assessments conducted at specific intervals.
3. Enter a 3-month, treatment-free follow-up phase, with SUI assessment.
4. 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.

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:

1. Females aged 22-70 years
2. MESA-UIQ SUI score must exceed MESA-UIQ UUI score
3. Investigator diagnosis of SUI at Baseline Study Visit A
4. µ-24-PWT >10 grams, and ≤74 grams
5. Positive PST (observed urine loss during coughing or Valsalva maneuver)
6. Able to independently read and willing to provide written informed consent and comply with all study visits and assessments required by study protocol
7. Able to independently read and complete all questionnaires and diaries provided in English
8. Negative urine test for urinary tract infection (UTI)
9. Negative urine test for pregnancy
10. 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.
11. Agrees not to participate in any other clinical research study(s) during this study
12. Willing to maintain same dose for any urge urinary incontinence (UUI) medications during study
13. 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:

1. Body Mass Index (BMI) >35

2. µ-24-PWT ≥ 75 grams

3. Subject is non-ambulatory

4. Inability to maintain the low lithotomy position in a relaxed manner for the duration of the treatment delivery during visit

5. Subject has any electrical or electromagnetic implanted medical devices

6. History of UUI or mixed incontinence with a predominant urge component

7. History of incontinence of neurogenic etiology

8. Subject is pregnant or <12-months post-partum

9. Pelvic organ prolapse (POP) (e.g., greater than Stage 2 as defined by the International Continence Society (e.g., cystocele, rectocele)

10. PVR urine test volume >150 mL

11. Prior treatments for SUI:

    1. Any SUI surgery (e.g., slings)
    2. Bulking agent injection within 1 year
    3. Electrostimulation or magnetic stimulation within 3 months
    4. Pessary or urethral plug unless removed at least two weeks prior to start of study
    5. Physical therapy or pelvic floor exercises, such as Kegel exercises, to strengthen pelvic floor muscles and urinary sphincter within the past 60 days

12. Diagnosis of pelvic pain

13. History of radiation to the pelvis

14. Any recent pelvic surgery (within 1 year)

15. History of bladder stone

16. History of interstitial cystitis

17. History of dyspareunia or external vaginal pain syndromes such as vulvodynia

18. Hematuria

19. Neurological diseases known to affect the bladder

20. Conditions posing additional risks:

    1. Bleeding disorder or currently taking anticoagulants
    2. 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
    3. History of cervical, uterine, bladder, urethral, or rectal cancer
    4. Genital warts, lesions, or sexually transmitted disease that are locally visible

21. Currently undergoing any incontinence treatment

22. Concurrent enrollment in another clinical trial

23. Not suitable for the study or is at risk of study non-compliance in the judgement of the Principal Investigator (PI)