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 andcomply with all study visits and assessments required by study protocol

7. Able to independently read and complete all questionnaires and diaries provided inEnglish

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 durationof the study period if of child-bearing potential. An oral contraceptive may bestarted at study enrollment. Intrauterine device (IUD) is allowed if placed prior tostudy 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) medicationsduring study

13. If taking any of the following medications (may not start during trial); oral orvaginal estrogen therapy or other medication known to affect incontinence, such astestosterone, growth hormones, alpha-blockers, sedative-hypnotics, antipsychotics,angiotensin-converting enzyme (ACE) inhibitors, loop diuretics, and calcium channelblockers, must be stable for 3 months prior, and willing to maintain same dosethroughout 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 theduration 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 theInternational Continence Society (e.g., cystocele, rectocele)

10. PVR urine test volume >150 mL

11. Prior treatments for SUI:

12. Any SUI surgery (e.g., slings)

13. Bulking agent injection within 1 year

14. Electrostimulation or magnetic stimulation within 3 months

15. Pessary or urethral plug unless removed at least two weeks prior to start ofstudy

16. Physical therapy or pelvic floor exercises, such as Kegel exercises, tostrengthen pelvic floor muscles and urinary sphincter within the past 60 days

17. Diagnosis of pelvic pain

18. History of radiation to the pelvis

19. Any recent pelvic surgery (within 1 year)

20. History of bladder stone

21. History of interstitial cystitis

22. History of dyspareunia or external vaginal pain syndromes such as vulvodynia

23. Hematuria

24. Neurological diseases known to affect the bladder

25. Conditions posing additional risks:

26. Bleeding disorder or currently taking anticoagulants

27. Current urinary infection - positive urine culture, signs of urinary infection;may repeat inclusion criteria urinary analysis (UA) after the UTI has beensuccessfully resolved with a full course of antibiotics and a report UA isnegative

28. History of cervical, uterine, bladder, urethral, or rectal cancer

29. Genital warts, lesions, or sexually transmitted disease that are locallyvisible

30. Currently undergoing any incontinence treatment

31. Concurrent enrollment in another clinical trial

32. Not suitable for the study or is at risk of study non-compliance in the judgement ofthe Principal Investigator (PI)