Stress Urinary Incontinence (SUI)
Conditions
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
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. 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.
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.
Interventions
DEVICESham Acoustic Stimulation Therapy Device
The sham intervention uses the same device setup with sham procedures.
DEVICEAcoustic Stimulation Therapy Device
The SUI-100 Device is a non-invasive device designed for the treatment of stress urinary incontinence (SUI) in females.
Sponsors
Acoustic Wave Cell Therapy, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
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).
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
22 Years to 77 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with a ≥50% reduction in urine leakage. | Immediately following intervention. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with a ≥80% reduction in urine leakage. | Immediately following intervention. | The proportion of participants achieving at least an 80% reduction in urine leakage as measured by the 24-Hour Pad Weight Test. |
| Percentage of participants with a ≥50% reduction in urine leakage after 10 treatments. | After 10 intervention 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). |
| Percentage of participants maintaining a ≥50% reduction in urine leakage after the maintenance phase. | Immediately after treatments are complete for the study. | The proportion of participants maintaining at least a 50% reduction in urine leakage after the maintenance phase. |
| 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. | Reduction (improvement) in IIQ-7 scores by at least 30% from baseline. |
| Durability of treatment effects after the follow-up phase. | 3 months after intervention | 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). |
Countries
United States
Outcome results
None listed