Stress Urinary Incontinence (SUI)SaHARANCT06862648
Evaluating SUI-100™, A Non-Invasive Device for the Treatment of Stress Urinary Incontinence
A study testing Acoustic Stimulation Therapy Device in people with Stress Urinary Incontinence (SUI), run by Acoustic Wave Cell Therapy, Inc. at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 77 years, women only
- Conditions the study is for
- Stress Urinary Incontinence (SUI)
- What is being tested?
- Acoustic Stimulation Therapy Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 9 sitesUnited States
- Study dates
- 25 Mar 2025to 9 Nov 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 77 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
- 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
- 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)
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Advanced Specialty Research
Boise, Idaho, 83702
Boeson Research GTF
Great Falls, Montana, 59405
Helios Clinical Research (TX)
Katy, Texas, 77494
Clinical Research of Central Florida
Lakeland, Florida, 33805
Foundation for Female Health Awareness
Las Vegas, Nevada, 89148
Advanced Specialty Research
Meridian, Idaho, 83646
Helios Clinical Research
Middleburg Heights, Ohio, 44130
Arizona Gynecology Consultants
Phoenix, Arizona, 85016
Cypress Medical Research Center
Wichita, Kansas, 67226
About this study
Official title: 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:
Read more
- Does treatment with the SUI-100 device reduce SUI symptoms, as measured by urine leakage.
- Is the device safe and effective compared to the sham group?
Participants will:
- Be randomly assigned to an active or sham control group in a blinded, multicenter study.
- Attend treatment visits during the Treatment Phase, with SUI assessments conducted at specific intervals.
- Enter a 3-month, treatment-free follow-up phase, with SUI assessment.
- 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.
Read the detailed description
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.
- Conditions
- Stress Urinary Incontinence (SUI)
- Being tested
- Acoustic Stimulation Therapy Device, Sham Acoustic Stimulation Therapy Device
- Keywords
- Stress Urinary Incontinence, Female Urinary Incontinence, Mild-to-Moderate SUI, Urine Leakage, Acoustic Energy Therapy, Non-Invasive Treatment, SUI-100 Device, Pivotal Study, Randomized Controlled Trial (RCT), Sham-Controlled Trial, Blinded Study, Multicenter Study, 24-Hour Pad Weight Test, Reduction in Urine Leakage, Improved Quality of Life, Symptom Improvement, Incontinence Impact Questionnaire (IIQ-7), Adverse Event Monitoring, Device Safety Evaluation, IRB Oversight
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acoustic Stimulation Therapy DeviceDevice
Also called SUI-100™ 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 DeviceDevice
Also called Sham SUI-100™ Device
The sham intervention uses the same device setup with sham procedures.
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment Arm | Experimental | Participants receive active sessions using the SUI-100 Device. Receives: Device: Acoustic Stimulation Therapy Device |
| Sham Treatment Arm | Sham comparator | Participants receive sham sessions using the SUI-100 Device. Receives: Device: Sham Acoustic Stimulation Therapy Device |
| Crossover Active Treatment Arm | Experimental | Sham participants who opt to crossover after unblinding receive active sessions with the SUI-100 Device. Receives: Device: Acoustic Stimulation Therapy Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with a ≥50% reduction in urine leakage.
The proportion of participants achieving at least a 50% reduction in urine leakage as measured by the average of three 24-Hour Pad Weight Tests (µ-24-PWT).
Measured: Immediately following intervention.
Secondary outcomes (5)
Percentage of participants with a ≥80% reduction in urine leakage.
The proportion of participants achieving at least an 80% reduction in urine leakage as measured by the 24-Hour Pad Weight Test.
Measured: Immediately following intervention.
Percentage of participants with a ≥50% reduction in urine leakage after 10 treatments.
The proportion of participants achieving at least a 50% reduction in urine leakage as measured by the average of three 24-Hour Pad Weight Tests (µ-24-PWT).
Measured: After 10 intervention treatments.
Percentage of participants maintaining a ≥50% reduction in urine leakage after the maintenance phase.
The proportion of participants maintaining at least a 50% reduction in urine leakage after the maintenance phase.
Measured: Immediately after treatments are complete for the study.
Quality-of-life improvement using the Incontinence Impact Questionnaire-Short Form (IIQ-7). (Reduction in score means improvement min: 0, max 21)
Reduction (improvement) in IIQ-7 scores by at least 30% from baseline.
Measured: Immediately following intervention.
Durability of treatment effects after the follow-up phase.
The proportion of participants maintaining a ≥50% reduction in urine leakage as measured by the average of three 24-Hour Pad Weight Tests (µ-24-PWT).
Measured: 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start25 Mar 2025
- Primary completion8 Sep 2026 (estimated)
- Study completion9 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary Incontinence (SUI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized with option for crossover: Participants assigned to the sham arm will have the option to crossover and receive active treatments after the unblinding phase.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acoustic Wave Cell Therapy, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06862648
- Sponsor's protocol ID
- SaHARA/SUI-003
- Acronym
- SaHARA
- Status last verified
- Apr 2026
- First submitted
- 12 Feb 2025
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No