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

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
• •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)