Actively Recruiting
Prospective, Post-market Study of the Desara4 One Single Incision Sling vs. Desara4 Blue Sling Implanted Via the Transobturator Route for the Treatment of Women With Stress Urinary Incontinence
Led by Caldera Medical, Inc. · Updated on 2025-09-19
300
Participants Needed
15
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the Desara4 One Single Incision Sling (SIS) compared to the Desara4 Blue sling system implanted through the transobturator-route (TOR) to treat women with stress urinary incontinence (SUI). This study involves adult females experiencing SUI due to urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The study is prospective, non-randomized, and conducted at multiple centers over 36 months. The study compares two devices: the Desara4 One Single Incision Sling and the Desara4 Blue Transobturator Sling. Each device will be implanted in separate groups of 150 participants. Follow-up visits are scheduled at 2 and 6 weeks, then at 6, 12, 18, 24, and 36 months after implantation. Participants may also undergo concomitant laparoscopic, robotic, or vaginal prolapse repair surgeries if needed. Participants will attend regular visits for evaluations including cough stress tests, sexual function assessments, pain assessments, and urinary symptom improvements. Researchers will monitor serious adverse events related to the devices and procedures, as well as measure success rates of negative cough stress tests at 36 months. The total study participation spans three years with multiple assessments to track outcomes and safety.
CONDITIONS
Brief 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 procedures and evaluations
- Provided signed informed consent
- Stress urinary incontinence confirmed by cough stress test with bladder pre-fill or ultrasound
- Stress incontinence greater than urge incontinence per MESA questionnaire
- No childbearing capacity or negative pregnancy test and decided to cease childbearing, confirmed by hysterectomy, tubal ligation, inability to become pregnant, or negative pregnancy test
- Offered and failed or refused non-invasive SUI treatments and elected surgical intervention
- Eligible for laparoscopic/robotic or vaginal prolapse repair procedures if needed
You will not qualify if you...
- Baseline pelvic pain of 2 or greater on a 10-point scale
- Known neurological disease or neurogenic bladder symptoms
- Known pre-existing pain syndrome or evaluated by pain management physician
- History of chronic opioid or narcotic use
- On anticoagulation therapy that cannot be stopped or adjusted before surgery
- On chronic systemic steroid treatment longer than 3 months (except inhalational use)
- Uncontrolled diabetes with A1c 7% or higher or fasting glucose over 130 mg/dl
- Active skin infection or lesion in the perineum, urethra, or vagina
- Active urinary tract infection requiring treatment
- Recurrent UTIs (3 or more in the past 6 months)
- Urethral obstruction or anatomic defects of the urethra
- Prior surgical treatment for stress urinary incontinence or prior pelvic floor mesh use or complications
- Conditions compromising implant placement or pelvic blood supply
- Bladder stones or tumors
- Abnormal bladder capacity less than 300 mL
- Post void residual volume 150 mL or greater on two measurements
- Previous pelvic radiation or brachytherapy
- Enrolled in another clinical trial affecting continence or outcomes
- Known allergy or sensitivity to polypropylene
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo implantation of either the Desara® One Single Incision Sling or the Desara® Blue Transobturator Sling to treat stress urinary incontinence.
1 visit (in-person)
Duration - 36 months
Participants are monitored with follow-up visits to assess treatment outcomes and safety after sling implantation.
Follow-up visits at 2 and 6 weeks, 6, 12, 18, 24, and 36 months
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
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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