Actively Recruiting
Desara ® One Single Incision Sling 522 Study
Led by Caldera Medical, Inc. · Updated on 2025-09-19
300
Participants Needed
15
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Desara ® One Single Incision Sling 522 Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 years or older
- Willing and able to return for all study-related procedures and evaluations
- Provided signed informed consent
- Confirmed stress urinary incontinence by supine or standing cough stress test with bladder pre-fill or confirmed bladder fullness via ultrasound
- Stress incontinence greater than urge incontinence as per MESA questionnaire
- No childbearing capacity or negative pregnancy test and decision to cease childbearing, confirmed by hysterectomy, tubal ligation, incapacity for pregnancy, or negative pregnancy test
- Offered and either failed or refused non-invasive SUI treatments and elected surgical intervention
- Eligible for concomitant laparoscopic/robotic or vaginal prolapse repair procedures (non-mesh)
You will not qualify if you...
- Baseline pelvic pain of 2 or higher on 10-point Numeric Rating Scale
- Known neurological disease with or without neurogenic bladder symptoms
- Known pre-existing pain syndrome or evaluation by interventional pain management physician
- History of chronic opioid or narcotic use for any reason
- On anticoagulation therapy that cannot be paused or adjusted before surgery
- On chronic systemic steroid treatment for over 3 months (except inhalational use)
- Uncontrolled diabetes (A1c 7% or fasting glucose >130 mg/dl)
- Active lesion or skin infection of perineum, urethra, or vagina
- Active urinary tract infection requiring treatment
- Recurrent urinary tract infections (3 or more in past 6 months)
- Urethral obstruction or anatomic defects such as diverticulum, stricture, or bladder neck contracture
- Prior surgical treatment for stress urinary incontinence, urethra surgery, distal anterior vaginal wall surgery, or prior pelvic floor mesh use or complications
- Bladder stones, tumors, or other pathologies compromising implant placement or pelvic blood supply or requiring chemotherapy or immunosuppressants
- Abnormal bladder capacity less than 300 mL
- Post void residual volume 150 mL or more on two measurements
- Prior pelvic radiation or brachytherapy
- Enrolled in conflicting clinical trial affecting continence
- Known allergy or sensitivity to polypropylene
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Valley Urogynecology Associates, Inc.
Phoenix, Arizona, United States, 85016
Actively Recruiting
2
University of Arizona College of Medicine
Tucson, Arizona, United States, 85724
Not Yet Recruiting
3
Urological Research Center Corp
Hialeah, Florida, United States, 33016
Actively Recruiting
4
Women's Health Care Associates P.A. dba Rosemark Women Care Specialists
Idaho Falls, Idaho, United States, 83404
Actively Recruiting
5
CMB Research, LLC
Newburgh, Indiana, United States, 47630
Actively Recruiting
6
University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
7
Mt. Auburn Hospital Division of Urogynecology
Cambridge, Massachusetts, United States, 02138
Actively Recruiting
8
Specialty Clinical Research of St. Louis, LLC
St Louis, Missouri, United States, 631471
Actively Recruiting
9
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States, 89169
Actively Recruiting
10
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Actively Recruiting
11
Novant Health Urogynecology
Charlotte, North Carolina, United States, 28210
Actively Recruiting
12
The Lindner Research Center at The Christ Hospital
Cincinnati, Ohio, United States, 45219
Actively Recruiting
13
Center for Total Women's Health
Lansdale, Pennsylvania, United States, 19446
Actively Recruiting
14
Center for Pelvic Health
Franklin, Tennessee, United States, 37067
Actively Recruiting
15
University of Washington Medical Center
Seattle, Washington, United States, 98195
Actively Recruiting
Research Team
V
Vicki Gail
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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