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
Acoustic Wave Cell Therapy, Inc.
130 participants
Mar 25, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria18
- 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
- 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)
Exclusion Criteria26
- 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
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Interventions
The SUI-100 Device is a non-invasive device designed for the treatment of stress urinary incontinence (SUI) in females.
The sham intervention uses the same device setup with sham procedures.
Locations(7)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06862648