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.
• 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