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Mid-urethral sling

RP vs. SIS Surgery for Stress Urinary Incontinence

N/A
Waitlist Available
Led By Catherine Matthews, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 21 years of age
POP ≥ stage II of any vaginal compartment, according to the pelvic organ prolapse quantification (POP-Q) system
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 month post-operatively
Awards & highlights

Study Summary

This trial is testing whether a new type of surgery for prolapse is as good as the current best surgery.

Who is the study for?
This trial is for English-speaking women at least 21 years old with pelvic organ prolapse (POP) stage II or higher and symptoms of stress urinary incontinence. They must be able to consent, return for follow-ups, complete questionnaires, and are considering native tissue vaginal repair. Excluded are those with poorly-controlled diabetes, prior pelvic radiation or surgery for incontinence, serious diseases affecting study compliance, pregnancy plans within a year post-surgery, incarceration status, certain bladder issues or unwillingness to have a synthetic sling.Check my eligibility
What is being tested?
The trial compares two surgical methods for treating stress urinary incontinence: the traditional retropubic (RP) sling placement versus the newer single-incision mid-urethral sling (SIS). It aims to determine if SIS can match RP's effectiveness while reducing complications like bladder injury and voiding dysfunction that may occur with RP slings.See study design
What are the potential side effects?
Potential side effects from both procedures include discomfort at the incision site, risk of bleeding and infection. The RP procedure might cause bladder injury or voiding problems. SIS seeks to minimize these risks but its own specific side effects will also be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am at least 21 years old.
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My pelvic organ prolapse is at least stage II.
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I am scheduled for surgery to repair pelvic organ prolapse using my own tissue.
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I am a woman being considered for a specific type of vaginal repair surgery.
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I feel a bulge in my vagina.
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I have a confirmed cough-related bladder leakage.
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I speak English and can give my consent.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 month post-operatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month post-operatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
De novo or worsening urge incontinence symptoms
Number of participants with subjectively bothersome stress incontinence
Requirement for bladder drainage
+2 more
Secondary outcome measures
Adverse events
Change in pain
Surgeon satisfaction

Trial Design

2Treatment groups
Experimental Treatment
Group I: SIS groupExperimental Treatment1 Intervention
Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure.
Group II: RP sling groupExperimental Treatment1 Intervention
Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SIS placement
2018
N/A
~280
RP sling placement
2018
N/A
~280

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,242 Previous Clinical Trials
1,003,975 Total Patients Enrolled
Foundation for Female Health AwarenessOTHER
2 Previous Clinical Trials
350 Total Patients Enrolled
Catherine Matthews, MDPrincipal InvestigatorWake Forest University Health Sciences
6 Previous Clinical Trials
393 Total Patients Enrolled

Media Library

Retropubic (RP) Sling (Mid-urethral sling) Clinical Trial Eligibility Overview. Trial Name: NCT03520114 — N/A
Stress Incontinence Research Study Groups: RP sling group, SIS group
Stress Incontinence Clinical Trial 2023: Retropubic (RP) Sling Highlights & Side Effects. Trial Name: NCT03520114 — N/A
Retropubic (RP) Sling (Mid-urethral sling) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03520114 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are the most that can enroll in this research project?

"That is correct. Presently, this clinical trial is recruiting patients. This study was posted on December 12th, 2018 and the most recent update occurred on October 26th, 2022. A total of 280 patients from 7 sites are being recruited for this trial."

Answered by AI

Are there any more places open for patients who want to participate in this clinical trial?

"Currently, this clinical trial is looking for participants. The date that the study was first posted on clinicaltrials.gov was December 12th, 2018 and it has undergone edits as recently as October 26th, 2022."

Answered by AI

Is this study taking place in more than one state?

"Currently, this clinical trial has recruited patients from Women's Center for Pelvic Health, Atrium in Charlotte, Women & Infants Hospital of Rhode island in Providence, and Cleveland Clinic in Cleveland. There are 7 other locations where recruiting is ongoing."

Answered by AI

Who else is applying?

What state do they live in?
Rhode Island
How old are they?
18 - 65
What site did they apply to?
Women & Infants Hospital of Rhode Island
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Retropubic vs. Single-Incision Mid-Urethral Sling for Stress Urinary Incontinence
2018. "Retropubic vs. Single-Incision Mid-Urethral Sling for Stress Urinary Incontinence". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03520114.
~44 spots leftby Apr 2025
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