Evaluating SUI-100™, A Non-Invasive Device for the Treatment of Stress Urinary Incontinence
NCT ID: NCT06862648
Last Updated: 2025-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
130 participants
INTERVENTIONAL
2025-03-25
2026-11-09
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active Treatment Arm
Participants receive active sessions using the SUI-100 Device.
Acoustic Stimulation Therapy Device
The SUI-100 Device is a non-invasive device designed for the treatment of stress urinary incontinence (SUI) in females.
Sham Treatment Arm
Participants receive sham sessions using the SUI-100 Device.
Sham Acoustic Stimulation Therapy Device
The sham intervention uses the same device setup with sham procedures.
Crossover Active Treatment Arm
Sham participants who opt to crossover after unblinding receive active sessions with the SUI-100 Device.
Acoustic Stimulation Therapy Device
The SUI-100 Device is a non-invasive device designed for the treatment of stress urinary incontinence (SUI) in females.
Interventions
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Acoustic Stimulation Therapy Device
The SUI-100 Device is a non-invasive device designed for the treatment of stress urinary incontinence (SUI) in females.
Sham Acoustic Stimulation Therapy Device
The sham intervention uses the same device setup with sham procedures.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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)
Exclusion Criteria
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
22 Years
77 Years
FEMALE
No
Sponsors
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Acoustic Wave Cell Therapy, Inc.
INDUSTRY
Responsible Party
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Locations
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Arizona Gynecology Consultants
Phoenix, Arizona, United States
Clinical Research of Central Florida
Winter Haven, Florida, United States
Advanced Specialty Research
Boise, 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
Countries
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Facility Contacts
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Other Identifiers
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SaHARA/SUI-003
Identifier Type: -
Identifier Source: org_study_id
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