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 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)