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Single-Incision vs Retropubic Sling for Stress Urinary Incontinence (SASS Trial)
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.
SASS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSASS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SASS Trial Design
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Who is running the clinical trial?
Media Library
- I have bladder issues not fixed by certain tests or devices.My diabetes is not well-managed with an HgbA1c over 9.You have been diagnosed with stress urinary incontinence based on a positive cough stress test or urodynamic study showing reduced prolapse.I have a current issue with abnormal connections in my urinary tract.I have had radiation therapy to my pelvic area before.I have had surgery for urinary leakage.I have inflammatory bowel disease.I am a woman being considered for a specific pelvic surgery.I am at least 21 years old.Currently in prison.I use self-catheterization due to bladder issues.I do not want a synthetic sling.I do not have any serious illness that could affect my participation in the study.I have a current urinary tract infection that hasn't been treated.I feel a bulge in my vagina, as per the PFDI-SF20 survey.I am scheduled for surgery related to bowel issues.My pelvic organ prolapse is at least stage II with apical descent.
- Group 1: SIS Group
- Group 2: RP Sling Group
- 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
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..."
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."
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."
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