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

Eligibility 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
• 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)