Non-invasive treatment for stress urinary incontinence using SUI-100 device
Pivotal Study of the SUI-100™ for the Treatment of Stress Urinary Incontinence (SUI): A Nonsignificant Risk (NSR) Device (SaHARA) Study
This study is testing a new non-invasive device to see if it can help women aged 22-70 with mild-to-moderate stress urinary incontinence reduce urine leakage.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 22 Years to 77 Years |
| Sex | Female |
| Sponsor | Acoustic Wave Cell Therapy, Inc. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 7 sites (Phoenix, Arizona and 6 other locations) |
| Trial ID | NCT06862648 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of the SUI-100 device, a non-invasive treatment for mild-to-moderate stress urinary incontinence (SUI) in women aged 22-70. Participants will be randomly assigned to receive either the active treatment or a sham device in a blinded, multicenter design. The study aims to measure the reduction in urine leakage and assess the device's safety compared to the sham group. Following the treatment phase, participants will enter a 3-month follow-up period to monitor outcomes.
Who should consider this trial
Good fit: Ideal candidates are females aged 22-70 with diagnosed mild-to-moderate stress urinary incontinence.
Not a fit: Patients with severe urinary incontinence or those who have undergone previous invasive treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a low-risk, effective alternative for women suffering from stress urinary incontinence.
How similar studies have performed: While this approach is novel, similar studies using non-invasive devices have shown promise in treating urinary incontinence.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Phoenix, Arizona and 6 other locations
- Arizona Gynecology Consultants — Phoenix, Arizona, United States (Recruiting)
- Clinical Research of Central Florida — Winter Haven, Florida, United States (Recruiting)
- Advanced Specialty Research — Boise, Idaho, United States (Recruiting)
- Cypress Medical Research Center — Wichita, Kansas, United States (Recruiting)
- Boeson Research GTF — Great Falls, Montana, United States (Recruiting)
- Foundation for Female Health Awareness — Las Vegas, Nevada, United States (Recruiting)
- Helios Clinical Research — Middleburg Heights, Ohio, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.