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Surgical Slings for Stress Urinary Incontinence
Study Summary
This trial will compare the safety and effectiveness of two types of surgical slings used to treat urinary incontinence in women.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have been diagnosed with stress urinary incontinence.You have had a bad reaction or allergy to polypropylene.I experience pelvic pain at a level of 2 or higher on a scale of 10.I have had radiation treatment to my pelvic area before.I have tried or decided against non-surgical treatments for SUI and chosen surgery.You have more trouble with leaking urine when you cough or sneeze than with a sudden, strong urge to go to the bathroom.I have a neurological disease, which may or may not affect my bladder.I am on blood thinners that can't be stopped for 1-2 days before sling surgery.I have a bladder that doesn't empty well, leaving 150 mL or more after I pee.I do not have bladder stones, tumors, or other conditions that could affect surgery or blood supply in my pelvis.You have more trouble with leaking urine when you cough or sneeze than with sudden, strong urges to urinate.My bladder cannot hold more than 300 mL.You have a known chronic pain condition and have been seen by a doctor who specializes in treating pain.You have a history of using strong pain medications for a long time.My diabetes is not under control, with high blood sugar or A1c levels.I have an active infection or lesion in my genital area.I have a blockage or defect in my urethra.I am a woman aged 18 or older.I am eligible for surgery to fix pelvic organ prolapse, with or without mesh.I am currently being treated for a urinary tract infection.I have had 3 or more UTIs proven by tests in the last 6 months.I have been on steroid pills for more than 3 months.I have had previous surgeries for urinary incontinence or on my urethra, vaginal wall, or used pelvic floor mesh.
- Group 1: Desara® One
- Group 2: Desara® Blue
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How pervasive is this research project in the city?
"Right now, 16 clinical trial sites are enrolling for this study. Along with Idaho Falls, Las Vegas and Franklin there are 13 other cities hosting recruitment centres. To reduce the burden of travel, it is recommended to select a location nearby when signing up for this clinical trial."
Are there vacancies in this research endeavor for participants?
"As outlined on clinicaltrials.gov, this trial is still accepting participants as of August 10th 2022. The initial posting for the study was November 1st 2021."
What are the desired outcomes of this research endeavor?
"This multi-year clinical trial will primarily evaluate the occurrence of adverse events associated with a particular medical device or procedure. Secondary assessments include composite success rates, patient impressions related to incontinence post-implant, time taken for voiding after implantation, and overall improvements in incontinence through use of the Patient Global Impression of Improvement index."
How many participants are actively taking part in this research study?
"To fulfill the requirements set out by this clinical trial, 300 patients with specific qualifications must be found. Women's Health Care Associates P.A. dba Rosemark Women Care Specialists in Idaho Falls and Women's Cancer Center of Nevada in Las Vegas are two potential sites for patient participation."
Who else is applying?
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What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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