Status:
RECRUITING
Desara ® One Single Incision Sling 522 Study
Lead Sponsor:
Caldera Medical, Inc.
Conditions:
Stress Urinary Incontinence
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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.
Detailed 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-rout...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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).
- Exclusion criteria:
- 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)
- Subject has had previous radiation therapy or brachytherapy to the pelvis.
- Subject is enrolled in a concurrent clinical trial of any treatment (drug or device) that could affect continence function, interfere with clinical outcomes, or impact analysis of this device.
- Subject has known reaction, sensitivity or allergy to polypropylene.
Exclusion
Key Trial Info
Start Date :
November 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04772131
Start Date
November 1 2021
End Date
November 1 2026
Last Update
September 19 2025
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
Valley Urogynecology Associates, Inc.
Phoenix, Arizona, United States, 85016
2
University of Arizona College of Medicine
Tucson, Arizona, United States, 85724
3
Urological Research Center Corp
Hialeah, Florida, United States, 33016
4
Women's Health Care Associates P.A. dba Rosemark Women Care Specialists
Idaho Falls, Idaho, United States, 83404