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Sling
Surgical Slings for Stress Urinary Incontinence
N/A
Recruiting
Research Sponsored by Caldera Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female ≥ 18 years of age
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)
Must not have
Subject reports baseline pelvic pain ≥ 2 on 10 point Numeric Rating Scale (NRS)
Subject has had previous radiation therapy or brachytherapy to the pelvis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks, 6, 12, 18, 24, 36 months
Awards & highlights
Summary
This trial will compare the safety and effectiveness of two types of surgical slings used to treat urinary incontinence in women.
Who is the study for?
This trial is for women over 18 with stress urinary incontinence who've tried non-surgical treatments without success. They must not be pregnant, have finished childbearing, and be able to attend follow-up visits. Exclusions include previous pelvic radiation therapy, polypropylene allergy, significant pelvic pain or neurological diseases affecting bladder control.
What is being tested?
The study compares the Desara® One Single Incision Sling (SIS) to an FDA-approved transobturator sling for treating urinary incontinence over three years. It aims to assess which method is safer and more effective.
What are the potential side effects?
Potential side effects may include discomfort at the surgery site, infection risk, possible reaction to materials used in slings like polypropylene (if not allergic), and complications related to urinary function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman aged 18 or older.
Select...
I am eligible for surgery to fix pelvic organ prolapse, with or without mesh.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I experience pelvic pain at a level of 2 or higher on a scale of 10.
Select...
I have had radiation treatment to my pelvic area before.
Select...
I have a neurological disease, which may or may not affect my bladder.
Select...
My bladder cannot hold more than 300 mL.
Select...
My diabetes is not under control, with high blood sugar or A1c levels.
Select...
I have an active infection or lesion in my genital area.
Select...
I have a blockage or defect in my urethra.
Select...
I am currently being treated for a urinary tract infection.
Select...
I have been on steroid pills for more than 3 months.
Select...
I have had previous surgeries for urinary incontinence or on my urethra, vaginal wall, or used pelvic floor mesh.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks, 6, 12, 18, 24, 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks, 6, 12, 18, 24, 36 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Device and Procedure-related serious adverse events
Coughing
Secondary study objectives
Composite outcome success rates
Improvement in Incontinence
Improvement in Urge and Stress Incontinence
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Desara® OneExperimental Treatment1 Intervention
Single Incision Sling
Group II: Desara® BlueActive Control1 Intervention
Transobturator Sling
Find a Location
Who is running the clinical trial?
Caldera Medical, Inc.Lead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Desara® One
- Group 2: Desara® Blue
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
Stress Incontinence Patient Testimony for trial: Trial Name: NCT04772131 — N/A
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