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Single-Incision vs Retropubic Sling for Stress Urinary Incontinence (SASS Trial)

N/A
Recruiting
Led By Catherine A 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
Women being considered for minimally invasive sacrocolpopexy (with or without concomitant hysterectomy)
At least 21 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, surgery, post op: week 2, week 6, year 1, year 2, year 3, and year 5
Awards & highlights

SASS Trial Summary

This trial will compare the effectiveness of a single-incision sling versus a retropubic sling for treating stress urinary incontinence during minimally invasive sacrocolpopexy.

Who is the study for?
Women over 21 with vaginal bulge symptoms, pelvic organ prolapse stage II or higher, and stress urinary incontinence are eligible. They must be able to consent, complete questionnaires, and return for follow-ups. Exclusions include neurogenic bladder issues, high post-void residuals, pregnancy plans, serious interfering conditions, unwillingness to have a synthetic sling, unresolved UTI's or poorly-controlled diabetes.Check my eligibility
What is being tested?
The SASS trial is testing two surgical methods for treating stress urinary incontinence during minimally invasive sacrocolpopexy: the Single-incision Sling (SIS) versus the Retropubic Mid-Urethral Sling (RP Sling). It's a multicenter study where participants are randomly assigned to one of these treatments without knowing which one they receive.See study design
What are the potential side effects?
Potential side effects may include discomfort at the incision site, bleeding or bruising around the area of surgery; there could also be risks related to anesthesia. Specific side effects related to each procedure will vary and can be discussed with healthcare providers.

SASS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman being considered for a specific pelvic surgery.
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I am at least 21 years old.
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I feel a bulge in my vagina, as per the PFDI-SF20 survey.
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My pelvic organ prolapse is at least stage II with apical descent.

SASS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, surgery, post op: week 2, week 6, year 1, year 2, year 3, and year 5
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, surgery, post op: week 2, week 6, year 1, year 2, year 3, and year 5 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with subjectively bothersome stress incontinence
Secondary outcome measures
Assessment of post-void residual (PVR) volume
Number of Participants needing Retreatment
Number of Participants needing bladder drainage
+5 more

SASS 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

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,234 Previous Clinical Trials
1,001,877 Total Patients Enrolled
Boston Scientific CorporationIndustry Sponsor
716 Previous Clinical Trials
934,325 Total Patients Enrolled
Catherine A Matthews, MDPrincipal InvestigatorWake Forest University Health Sciences
3 Previous Clinical Trials
316 Total Patients Enrolled

Media Library

SIS Clinical Trial Eligibility Overview. Trial Name: NCT04586166 — N/A
Stress Incontinence Research Study Groups: SIS Group, RP Sling Group
Stress Incontinence Clinical Trial 2023: SIS Highlights & Side Effects. Trial Name: NCT04586166 — N/A
SIS 2023 Treatment Timeline for Medical Study. Trial Name: NCT04586166 — N/A

Frequently Asked Questions

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

What is the scope of this medical investigation, in terms of how many hospitals are taking part?

"Five medical centres are currently running this trial, such as Boston Urogynecology Associates in Cambridge, Augusta University in Augusta and Florida Robotic and Minimally Invasive Urogynecology in Coconut Creek. Other participating sites include..."

Answered by AI

Is this clinical trial currently seeking participants?

"Data hosted on clinicaltrials.gov affirms that this experiment is currently enrolling participants, having been first posted on December 23rd 2020 and last updated July 26th 2022."

Answered by AI

How many individuals have been recruited to participate in this clinical trial?

"The sponsor, Boston Scientific Corporation, requires 180 eligible patients to facilitate the medical research. In order to meet this quota, they will be running the trial out of selected locations such as Boston Urogynecology Associates in Cambridge and Augusta University in Georgia."

Answered by AI
~101 spots leftby Jun 2028