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

NCT06862648 | Active Not Recruiting FDA Device

• 1 other identifier: SaHARA/SUI-003
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 9

Brief 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. 1.Does treatment with the SUI-100 device reduce SUI symptoms, as measured by urine leakage.
2. 2.Is the device safe and effective compared to the sham group?
3. 3.Be randomly assigned to an active or sham control group in a blinded, multicenter study.
4. 4.Attend treatment visits during the Treatment Phase, with SUI assessments conducted at specific intervals.
5. 5.Enter a 3-month, treatment-free follow-up phase, with SUI assessment.
6. 6.Proceed to three monthly maintenance treatments, followed by a final SUI assessment at study exit.

Conditions

Stress Urinary Incontinence (SUI)

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; Female Participants; Ages 22-70; Non-Surgical Candidates; Conservative Treatment Options; Baseline Assessments; Treatment Phase; Follow-Up Phase; Maintenance Phase; Semi-Weekly Treatments; Crossover Option; Low-Risk Intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Percentage of participants with a ≥80% reduction in urine leakage.

  Immediately following intervention.

• Percentage of participants with a ≥50% reduction in urine leakage after 10 treatments.

  After 10 intervention treatments.

• Percentage of participants maintaining 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)

  Immediately following intervention.

• Durability of treatment effects after the follow-up phase.

  3 months after intervention

Other Outcomes (1)

• Safety of the SUI-100 Device as determined by adverse events (AEs) and adverse device effects (ADEs).

  Through study completion, an average of 9 months

Study Arms (3)

Active Treatment Arm

EXPERIMENTAL

Participants receive active sessions using the SUI-100 Device.

Device: Acoustic Stimulation Therapy Device

Sham Treatment Arm

SHAM COMPARATOR

Participants receive sham sessions using the SUI-100 Device.

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.

Device: Acoustic Stimulation Therapy Device

Interventions

Acoustic Stimulation Therapy Device DEVICE

The SUI-100 Device is a non-invasive device designed for the treatment of stress urinary incontinence (SUI) in females.

Also known as: SUI-100™ Device

Active Treatment Arm; Crossover Active Treatment Arm

Sham Acoustic Stimulation Therapy Device DEVICE

The sham intervention uses the same device setup with sham procedures.

Also known as: Sham SUI-100™ Device

Sham Treatment Arm

Eligibility Criteria

• Age: 22 Years - 77 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Acoustic Wave Cell Therapy, Inc.: lead

Study Sites (9)

Arizona Gynecology Consultants

Phoenix, Arizona, 85016, United States

Location

Clinical Research of Central Florida

Lakeland, Florida, 33805, United States

Location

Advanced Specialty Research

Boise, Idaho, 83702, United States

Location

Advanced Specialty Research

Meridian, Idaho, 83646, United States

Location

Cypress Medical Research Center

Wichita, Kansas, 67226, United States

Location

Boeson Research GTF

Great Falls, Montana, 59405, United States

Location

Foundation for Female Health Awareness

Las Vegas, Nevada, 89148, United States

Location

Helios Clinical Research

Middleburg Heights, Ohio, 44130, United States

Location

Helios Clinical Research (TX)

Katy, Texas, 77494, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The principal investigator will remain blinded until study unblinding occurs. Study staff will assemble the machine before each session so that the participant will only see the device in the assembly for which they are assigned (active or sham).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: March 6, 2025
• Study Start: March 25, 2025
• Primary Completion (Estimated): September 8, 2026
• Study Completion (Estimated): November 9, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)