RECRUITING

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

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Conditions

Stress Urinary Incontinence (SUI)Stress Urinary IncontinenceFemale Urinary IncontinenceMild-to-Moderate SUIUrine LeakageAcoustic Energy TherapyNon-Invasive TreatmentSUI-100 DevicePivotal StudyRandomized Controlled Trial (RCT)Sham-Controlled TrialBlinded StudyMulticenter Study24-Hour Pad Weight TestReduction in Urine LeakageImproved Quality of LifeSymptom ImprovementIncontinence Impact Questionnaire (IIQ-7)Adverse Event MonitoringDevice Safety EvaluationIRB OversightFemale ParticipantsAges 22-70Non-Surgical CandidatesConservative Treatment OptionsBaseline AssessmentsTreatment PhaseFollow-Up PhaseMaintenance PhaseSemi-Weekly TreatmentsCrossover OptionLow-Risk Intervention

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pivotal Study of the SUI-100™ for the Treatment of Stress Urinary Incontinence (SUI): A Nonsignificant Risk (NSR) Device (SaHARA) Study

Quick Facts

Study Start:2025-03-25
Study Completion:2026-11-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06862648

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 77 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Females aged 22-70 years
  2. 2. MESA-UIQ SUI score must exceed MESA-UIQ UUI score
  3. 3. Investigator diagnosis of SUI at Baseline Study Visit A
  4. 4. µ-24-PWT \>10 grams, and ≤74 grams
  5. 5. Positive PST (observed urine loss during coughing or Valsalva maneuver)
  6. 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. 7. Able to independently read and complete all questionnaires and diaries provided in English
  8. 8. Negative urine test for urinary tract infection (UTI)
  9. 9. Negative urine test for pregnancy
  10. 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. 11. Agrees not to participate in any other clinical research study(s) during this study
  12. 12. Willing to maintain same dose for any urge urinary incontinence (UUI) medications during study
  13. 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
  1. 1. Body Mass Index (BMI) \>35
  2. 2. µ-24-PWT ≥ 75 grams
  3. 3. Subject is non-ambulatory
  4. 4. Inability to maintain the low lithotomy position in a relaxed manner for the duration of the treatment delivery during visit
  5. 5. Subject has any electrical or electromagnetic implanted medical devices
  6. 6. History of UUI or mixed incontinence with a predominant urge component
  7. 7. History of incontinence of neurogenic etiology
  8. 8. Subject is pregnant or \<12-months post-partum
  9. 9. Pelvic organ prolapse (POP) (e.g., greater than Stage 2 as defined by the International Continence Society (e.g., cystocele, rectocele)
  10. 10. PVR urine test volume \>150 mL
  11. 11. Prior treatments for SUI:
  12. 1. Any SUI surgery (e.g., slings)
  13. 2. Bulking agent injection within 1 year
  14. 3. Electrostimulation or magnetic stimulation within 3 months
  15. 4. Pessary or urethral plug unless removed at least two weeks prior to start of study
  16. 5. Physical therapy or pelvic floor exercises, such as Kegel exercises, to strengthen pelvic floor muscles and urinary sphincter within the past 60 days
  17. 12. Diagnosis of pelvic pain
  18. 13. History of radiation to the pelvis
  19. 14. Any recent pelvic surgery (within 1 year)
  20. 15. History of bladder stone
  21. 16. History of interstitial cystitis
  22. 17. History of dyspareunia or external vaginal pain syndromes such as vulvodynia
  23. 18. Hematuria
  24. 19. Neurological diseases known to affect the bladder
  25. 20. Conditions posing additional risks:
  26. 1. Bleeding disorder or currently taking anticoagulants
  27. 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
  28. 3. History of cervical, uterine, bladder, urethral, or rectal cancer
  29. 4. Genital warts, lesions, or sexually transmitted disease that are locally visible
  30. 21. Currently undergoing any incontinence treatment
  31. 22. Concurrent enrollment in another clinical trial
  32. 23. Not suitable for the study or is at risk of study non-compliance in the judgement of the Principal Investigator (PI)

Contacts and Locations

Study Locations (Sites)

Arizona Gynecology Consultants
Phoenix, Arizona, 85016
United States
Clinical Research of Central Florida
Winter Haven, Florida, 33880
United States
Advanced Specialty Research
Boise, Idaho, 83702
United States
Cypress Medical Research Center
Wichita, Kansas, 67226
United States
Boeson Research GTF
Great Falls, Montana, 59405
United States
Foundation for Female Health Awareness
Las Vegas, Nevada, 89148
United States
Helios Clinical Research
Middleburg Heights, Ohio, 44130
United States

Collaborators and Investigators

Sponsor: Acoustic Wave Cell Therapy, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-25
Study Completion Date2026-11-09

Study Record Updates

Study Start Date2025-03-25
Study Completion Date2026-11-09

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

  • Stress Urinary Incontinence (SUI)