Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2021-11-01
2026-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Desara® One
Single Incision Sling
Desara® One Single Incision Sling
Single incision sling
Desara® Blue
Transobturator Sling
Desara® Blue Transobturator Sling
Standard mid-urethral sling
Interventions
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Desara® One Single Incision Sling
Single incision sling
Desara® Blue Transobturator Sling
Standard mid-urethral sling
Eligibility Criteria
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Inclusion Criteria
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 test and has decided to cease childbearing. Childbearing capacity to be confirmed by documented history of:
1. A hysterectomy or
2. Tubal ligation or
3. Is otherwise incapable of pregnancy or has
4. Negative pregnancy test prior to study entry and has decided to cease childbearing
7. Subject has been offered and either failed or refused alternative non-invasive SUI treatment options and has elected to proceed with a surgical intervention.
8. 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
2. Subject has a known neurological disease (with or without signs/symptoms of neurogenic bladder).
3. Subject has known pre-existing pain syndrome and/or has been evaluated by an interventional pain management physician.
4. Subject has a history of chronic opioid, or narcotic use for:
1. pain or
2. any other specified reason
5. 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.
6. Subject is on chronic (\> 3 months) systemic steroid treatment (except for inhalational use as indicated for pulmonary conditions).
7. Subject has uncontrolled diabetes defined as A1c ≥ 7% or fasting serum glucose \> 130mg/dl at screening/baseline.
8. Subject has an active lesion or skin infection of the perineum, urethra, or vagina as noted per visual pelvic exam.
9. Subject has active UTI which requires treatment, as determined by the Investigator.
10. Subject has pattern of recurrent UTIs, defined as ≥ 3 culture-proven UTIs during the 6-month period prior to surgery.
11. Subject has a urethral obstruction or other anatomic defects of the urethra (inclusive of urethral diverticulum or stricture or bladder neck contracture).
12. The subject has had:
1. any prior surgical stress urinary incontinence treatment or
2. any prior surgery on their urethra or
3. any prior surgery to distal anterior vaginal wall, including fistula repair or prior cystocele repair
4. any previous pelvic floor mesh use or complication
13. Subject has any of the following confounding conditions:
1. bladder stones or tumors
2. pathology that in the opinion of the Investigator would compromise implant placement
3. pathology that would limit pelvic blood supply
4. pathology that would require chemotherapy and systemic use of immunosuppressants
14. Subject has abnormal bladder capacity \<300 mL.
15. 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)
16. Subject has had previous radiation therapy or brachytherapy to the pelvis.
17. 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.
18. Subject has known reaction, sensitivity or allergy to polypropylene.
18 Years
FEMALE
No
Sponsors
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Caldera Medical, Inc.
INDUSTRY
Responsible Party
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Locations
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Valley Urogynecology Associates, Inc.
Phoenix, Arizona, United States
University of Arizona College of Medicine
Tucson, Arizona, United States
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
Novant Health Urogynecology
Charlotte, North Carolina, United States
The Lindner Research Center at The Christ Hospital
Cincinnati, Ohio, United States
Center for Total Women's Health
Lansdale, Pennsylvania, United States
Center for Pelvic Health
Franklin, Tennessee, United States
University of Washington Medical Center
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Gena Sayat, LPN
Role: primary
Other Identifiers
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PS200005
Identifier Type: -
Identifier Source: org_study_id
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