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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
No Placebo-Only Group

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 below
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I am a woman aged 18 or older.
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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:
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I experience pelvic pain at a level of 2 or higher on a scale of 10.
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I have had radiation treatment to my pelvic area before.
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I have a neurological disease, which may or may not affect my bladder.
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My bladder cannot hold more than 300 mL.
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My diabetes is not under control, with high blood sugar or A1c levels.
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I have an active infection or lesion in my genital area.
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I have a blockage or defect in my urethra.
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I am currently being treated for a urinary tract infection.
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I have been on steroid pills for more than 3 months.
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I have had previous surgeries for urinary incontinence or on my urethra, vaginal wall, or used pelvic floor mesh.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks, 6, 12, 18, 24, 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks, 6, 12, 18, 24, 36 months for reporting.

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 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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

Desara® Blue Transobturator Sling (Sling) Clinical Trial Eligibility Overview. Trial Name: NCT04772131 — N/A
Stress Incontinence Research Study Groups: Desara® One, Desara® Blue
Stress Incontinence Clinical Trial 2023: Desara® Blue Transobturator Sling Highlights & Side Effects. Trial Name: NCT04772131 — N/A
Desara® Blue Transobturator Sling (Sling) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04772131 — N/A
Stress Incontinence Patient Testimony for trial: Trial Name: NCT04772131 — N/A
~115 spots leftby Nov 2026
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