Evaluating SUI-100™, A Non-Invasive Device for the Treatment of Stress Urinary Incontinence
Running, not enrolling · Not applicable · Has a placebo group
Conditions studied: Stress Urinary Incontinence (SUI)
In brief
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.
Key facts
- Study ID
- NCT06862648
- Run by
- Acoustic Wave Cell Therapy, Inc.
- People needed
- 130
- Starts
- 2025-03-25
- Expected to finish
- 2026-11-09
- Last updated by the study team
- 2026-04-09
Who can join
Age: 22 and older, up to 77. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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:
Where it is running
- Arizona Gynecology Consultants — Phoenix, Arizona, United States
- Clinical Research of Central Florida — Lakeland, Florida, United States
- Advanced Specialty Research — Boise, Idaho, United States
- Advanced Specialty Research — Meridian, Idaho, United States
- Cypress Medical Research Center — Wichita, Kansas, United States
- Boeson Research GTF — Great Falls, Montana, United States
- Foundation for Female Health Awareness — Las Vegas, Nevada, United States
- Helios Clinical Research — Middleburg Heights, Ohio, United States
- Helios Clinical Research (TX) — Katy, Texas, United States
Full record on ClinicalTrials.gov
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