Prospective, Post-market Study of the Desara® One Single Incision Sling vs. Desara® Blue Sling Implanted Via the Transobturator Route for the Treatment of Women With Stress Urinary Incontinence
Caldera Medical, Inc.
Summary
A post-market study to compare the safety and effectiveness of the Desara® One Single Incision Sling (SIS), when compared to that of an FDA cleared transobturator sling over a period of 36 months.
Description
This study is a prospective, non-randomized, parallel cohort, multi-center study of Desara® One single incision sling (SIS) compared to Desara® Blue sling systems implanted via the transobturator-route (TOR) for the treatment of women with stress urinary incontinence (SUI). The study will compare results from SIS patients (N=150) and TOR patients (N=150) at up to 40 sites for a total period of 36 months, with follow-up visits at 2 and 6 weeks, 6, 12, 18, 24 and 36 months. This study will enroll adult females who are clinically indicated for a mid-urethral implant for the treatment of female st…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Female ≥ 18 of age. 2. Subject agrees that she is willing and able to return for all study related procedures and evaluations. 3. Subject has provided signed informed consent. 4. Subject has stress urinary incontinence (SUI) confirmed by either supine or standing cough stress test (CST) with bladder pre-fill to subjective fullness with 200-300 mL, or with bladder fullness confirmed via ultrasound. 5. Subject has confirmed stress incontinence greater than urge incontinence per MESA questionnaire. 6. Subject no longer has childbearing capacity or has a negative pregnancy…
Interventions
- DeviceDesara® One Single Incision Sling
Single incision sling
- DeviceDesara® Blue Transobturator Sling
Standard mid-urethral sling
Locations (15)
- Valley Urogynecology Associates, Inc.Phoenix, Arizona
- University of Arizona College of MedicineTucson, Arizona
- Urological Research Center CorpHialeah, Florida
- Women's Health Care Associates P.A. dba Rosemark Women Care SpecialistsIdaho Falls, Idaho
- CMB Research, LLCNewburgh, Indiana
- University of LouisvilleLouisville, Kentucky