Desara ® One Single Incision Sling 522 Study

Recruiting now · Not applicable

Conditions studied: Stress Urinary Incontinence

In brief

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.

Key facts

Study ID

NCT04772131

Run by

Caldera Medical, Inc.

People needed

300

Starts

2021-11-01

Expected to finish

2026-11-01

Last updated by the study team

2025-09-19

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female ≥ 18 of age.
• Subject agrees that she is willing and able to return for all study related procedures and evaluations.
• Subject has provided signed informed consent.
• 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.
• Subject has confirmed stress incontinence greater than urge incontinence per MESA questionnaire.
• Subject no longer has childbearing capacity or has a negative pregnancy test and has decided to cease childbearing. Childbearing capacity to be confirmed by documented history of:
• A hysterectomy or
• Tubal ligation or
• Is otherwise incapable of pregnancy or has
• Negative pregnancy test prior to study entry and has decided to cease childbearing
• Subject has been offered and either failed or refused alternative non-invasive SUI treatment options and has elected to proceed with a surgical intervention.
• Subject is eligible to undergo laparoscopic/robotic (with or without mesh) or vaginal (with or without mesh) apical, anterior or posterior prolapse concomitant surgical repair procedures (non-mesh).

You may not qualify if…

• Subject reports baseline pelvic pain ≥ 2 on 10 point Numeric Rating Scale (NRS).
• Subject has a known neurological disease (with or without signs/symptoms of neurogenic bladder).
• Subject has known pre-existing pain syndrome and/or has been evaluated by an interventional pain management physician.
• Subject has a history of chronic opioid, or narcotic use for:
• pain or
• any other specified reason
• Subject is on anti-coagulation therapy that cannot be suspended or adjusted for a minimum of 24-48 hours prior to planned sling implantation surgery.
• Subject is on chronic (> 3 months) systemic steroid treatment (except for inhalational use as indicated for pulmonary conditions).
• Subject has uncontrolled diabetes defined as A1c ≥ 7% or fasting serum glucose > 130mg/dl at screening/baseline.
• Subject has an active lesion or skin infection of the perineum, urethra, or vagina as noted per visual pelvic exam.
• Subject has active UTI which requires treatment, as determined by the Investigator.
• Subject has pattern of recurrent UTIs, defined as ≥ 3 culture-proven UTIs during the 6-month period prior to surgery.
• Subject has a urethral obstruction or other anatomic defects of the urethra (inclusive of urethral diverticulum or stricture or bladder neck contracture).
• The subject has had:
• any prior surgical stress urinary incontinence treatment or
• any prior surgery on their urethra or
• any prior surgery to distal anterior vaginal wall, including fistula repair or prior cystocele repair
• any previous pelvic floor mesh use or complication
• Subject has any of the following confounding conditions:
• bladder stones or tumors
• pathology that in the opinion of the Investigator would compromise implant placement
• pathology that would limit pelvic blood supply
• pathology that would require chemotherapy and systemic use of immunosuppressants
• Subject has abnormal bladder capacity <300 mL.
• Subject has a post void residual volume ≥ 150 mL on two different measurements. (Prolapse reduction during PVR measurement is only allowed if a prolapse repair will be performed concomitantly with the sling implantation)

Where it is running

• University of Washington Medical Center — Seattle, Washington, United States (enrolling)
• Valley Urogynecology Associates, Inc. — Phoenix, Arizona, United States (enrolling)
• Urological Research Center Corp — Hialeah, Florida, United States (enrolling)
• Women's Health Care Associates P.A. dba Rosemark Women Care Specialists — Idaho Falls, Idaho, United States (enrolling)
• CMB Research, LLC — Newburgh, Indiana, United States (enrolling)
• University of Louisville — Louisville, Kentucky, United States (enrolling)
• Mt. Auburn Hospital Division of Urogynecology — Cambridge, Massachusetts, United States (enrolling)
• Specialty Clinical Research of St. Louis, LLC — St Louis, Missouri, United States (enrolling)
• Women's Cancer Center of Nevada — Las Vegas, Nevada, United States (enrolling)
• University of New Mexico — Albuquerque, New Mexico, United States (enrolling)
• Novant Health Urogynecology — Charlotte, North Carolina, United States (enrolling)
• The Lindner Research Center at The Christ Hospital — Cincinnati, Ohio, United States (enrolling)
• Center for Total Women's Health — Lansdale, Pennsylvania, United States (enrolling)
• Center for Pelvic Health — Franklin, Tennessee, United States (enrolling)
• University of Arizona College of Medicine — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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