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.
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 stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
Single incision sling
Standard mid-urethral sling
Valley Urogynecology Associates, Inc.
Phoenix, Arizona, United States
University of Arizona College of Medicine
Tucson, Arizona, United States
Success rate of negative standing cough stress test (CST)
Negative standing cough stress test (CST) with bladder pre-fill to subjective fullness with 200-300 mL, or with bladder fullness confirmed via ultrasound, evaluated at the 36-month post-implant follow-up visit. The success rate is defined as the proportion of subjects with a negative CST at the 36-month post-implant follow-up
Time frame: 36 months
Device and Procedure-related serious adverse events
* Device- and/or procedure-related adverse event rates at the post-implant follow-up visits * Revision/re-surgery rates at post-implant follow-up visits * Device and/or procedure-related serious adverse events
Time frame: 36 months
Composite outcome success rates
Defined by the primary effectiveness endpoint and subjective measure of Improvement in the Patient Global Impression of Improvement (PGI-I) index for incontinence post-implant
Time frame: 6 weeks, 6, 12, 18, 24, 36 months
Sexual Function Assessment
Use of PISQ-12: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire to assess subject changes in sexual function
Time frame: 6 weeks, 6, 12, 18, 24, 36 months
Improvement in Incontinence
Use of PGI-I: Patients Global Impression of Improvement index for incontinence to assess subject improvement post-implant
Time frame: 6 weeks, 6, 12, 18, 24, 36 months
Improvement in Urinary Symptoms
Use of IIQ-7: Incontinence Impact Questionnaire, Short Form and ICIQ-UI: International Consultation on Incontinence Questionnaire-Urinary Incontinence to assess improvement in urinary symptoms post-implant
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Urological Research Center Corp
Hialeah, Florida, United States
Women's Health Care Associates P.A. dba Rosemark Women Care Specialists
Idaho Falls, Idaho, United States
CMB Research, LLC
Newburgh, Indiana, United States
University of Louisville
Louisville, Kentucky, United States
Mt. Auburn Hospital Division of Urogynecology
Cambridge, Massachusetts, United States
Specialty Clinical Research of St. Louis, LLC
St Louis, Missouri, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States
University of New Mexico
Albuquerque, New Mexico, United States
...and 5 more locations
Time frame: 6 weeks, 6, 12, 18, 24, 36 months
Improvement in Urge and Stress Incontinence
Use of UDI-6 SF: Urinary Distress Inventory, Short Form to assess subject improvement in urge and stress incontinence post-implant
Time frame: 6 weeks, 6, 12, 18, 24, 36 months
Subject pain assessment
Use of Numeric Rating 10-point scale (NRS) to assess post-operative pain. Pain scale is 0= no pain to 10 = worst pain
Time frame: 6 weeks, 6, 12, 18, 24, 36 months
Time to void post-implant
Perform a standard post void residual test to confirm that the subject's residual urine volume is ≥150 mL
Time frame: 6 weeks, 6, 12, 18, 24, 36 months