Evaluating SUI-100™, A Non-Invasive Device for the Treatment of Stress Urinary Incontinence (SaHARA)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stress Urinary Incontinence (SUI)
• Intervention / Treatment: Device: Acoustic Stimulation Therapy Device; Device: Sham Acoustic Stimulation Therapy Device

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.

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Arizona Gynecology Consultants
  • Florida
    • Lakeland, Florida, United States, 33805
      • Clinical Research of Central Florida
  • Idaho
    • Boise, Idaho, United States, 83702
      • Advanced Specialty Research
    • Meridian, Idaho, United States, 83646
      • Advanced Specialty Research
  • Kansas
    • Wichita, Kansas, United States, 67226
      • Cypress Medical Research Center
  • Montana
    • Great Falls, Montana, United States, 59405
      • Boeson Research GTF
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • Foundation for Female Health Awareness
  • Ohio
    • Middleburg Heights, Ohio, United States, 44130
      • Helios Clinical Research
  • Texas
    • Katy, Texas, United States, 77494
      • Helios Clinical Research (TX)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Females aged 22-70 years
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

Exclusion Criteria:

1. Body Mass Index (BMI) >35
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
    2. 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
    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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Treatment Arm; Participants receive active sessions using the SUI-100 Device.	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.; Other Names: SUI-100™ Device
Sham Comparator: Sham Treatment Arm; Participants receive sham sessions using the SUI-100 Device.	Device: Sham Acoustic Stimulation Therapy Device; The sham intervention uses the same device setup with sham procedures.; Other Names: Sham SUI-100™ Device
Experimental: Crossover Active Treatment Arm; Sham participants who opt to crossover after unblinding receive active sessions with the SUI-100 Device.	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.; Other Names: SUI-100™ Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Immediately following intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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.	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.	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).	3 months after intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of the SUI-100 Device as determined by adverse events (AEs) and adverse device effects (ADEs).	All AEs and ADEs will be monitored, documented, and graded for severity and relationship to the study device.	Through study completion, an average of 9 months

Collaborators and Investigators

• Sponsor: Acoustic Wave Cell Therapy, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2025
• Primary Completion (Estimated): September 8, 2026
• Study Completion (Estimated): November 9, 2026

Study Registration Dates

• First Submitted: February 12, 2025
• First Submitted That Met QC Criteria: March 4, 2025
• First Posted (Actual): March 6, 2025

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Stress Urinary Incontinence; Symptom Improvement; Randomized Controlled Trial (RCT); Multicenter Study; Urine Leakage; Adverse Event Monitoring; Baseline Assessments; Pivotal Study; Female Urinary Incontinence; Mild-to-Moderate SUI; Acoustic Energy Therapy; Non-Invasive Treatment; SUI-100 Device; Sham-Controlled Trial; Blinded Study; 24-Hour Pad Weight Test; Reduction in Urine Leakage; Improved Quality of Life; Incontinence Impact Questionnaire (IIQ-7); Device Safety Evaluation; IRB Oversight; Female Participants; Ages 22-70; Non-Surgical Candidates; Conservative Treatment Options; Treatment Phase; Follow-Up Phase; Maintenance Phase; Semi-Weekly Treatments; Crossover Option; Low-Risk Intervention
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Incontinence; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence, Stress
• Other Study ID Numbers: SaHARA/SUI-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No