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Procedure
Surgical Procedures for Uterovaginal Prolapse (SUPeR Trial)
N/A
Waitlist Available
Led By Sonia Thomas, DrPH
Research Sponsored by NICHD Pelvic Floor Disorders Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Prolapse beyond the hymen (defined as Ba, Bp, or C > 0 cm)
Women aged 21 or older who have completed child-bearing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6, 12, 18, 24, 30, and 36 months
Awards & highlights
SUPeR Trial Summary
This trial is comparing two different surgeries for uterovaginal prolapse. The primary aim is to determine whether treatment success in women who undergo the two strategies differ at time points through 3 years.
Who is the study for?
This trial is for women over 21 who've finished having children, are not pregnant, and can follow up for up to 5 years. They should have uterovaginal prolapse beyond the hymen with bothersome symptoms but no history of certain pelvic treatments or conditions that would exclude them from safe participation.Check my eligibility
What is being tested?
The study compares two surgical methods for fixing uterine prolapse: a mesh-augmented hysteropexy versus vaginal hysterectomy with uterosacral ligament suspension. It aims to see which method is more effective over three years.See study design
What are the potential side effects?
Potential side effects may include discomfort at the surgery site, bleeding, infection risk, possible problems related to mesh use like erosion or reaction, and general risks associated with anesthesia and surgeries.
SUPeR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My pelvic organ prolapse extends beyond the vaginal opening.
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I am a woman over 21 and have finished having children.
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My uterus has descended into the lower half of my vagina.
Select...
I feel like something is bulging or falling out of my body.
SUPeR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6, 12, 18, 24, 30, and 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6, 12, 18, 24, 30, and 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cumulative Trauma Disorders
Secondary outcome measures
At-visit Failure
Other outcome measures
Change From Baseline Body Image Scale
Pain
Change From Baseline CRADI Score
+19 moreSUPeR Trial Design
2Treatment groups
Active Control
Group I: Hysterectomy and USLSActive Control1 Intervention
Vaginal hysterectomy and uterosacral ligament suspension (USLS)
Group II: HysteropexyActive Control1 Intervention
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Who is running the clinical trial?
NICHD Pelvic Floor Disorders NetworkLead Sponsor
13 Previous Clinical Trials
4,112 Total Patients Enrolled
Boston Scientific CorporationIndustry Sponsor
718 Previous Clinical Trials
932,765 Total Patients Enrolled
Sonia Thomas, DrPHPrincipal InvestigatorRTI International
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received radiation therapy to my pelvis.My pelvic organ prolapse extends beyond the vaginal opening.My cervix is expected to be low in position after a specific pelvic surgery.I am at high risk for cervical issues and need screenings more often due to factors like HIV, immune suppression, DES exposure, or past treatments.I need my ovaries removed due to a mass, BRCA gene, or family cancer history.My uterus has descended into the lower half of my vagina.I feel like something is bulging or falling out of my body.I want surgery through the vagina for pelvic organ prolapse.I haven't had a cervical cancer screening in 3 years or more.I have a uterine condition that prevents safe prolapse surgery.I am not menstruating due to hormone treatments or a brain condition.I am a woman over 21 and have finished having children.I have ongoing pain in my lower abdomen or pelvis.I have had a surgery to support my uterus before.
Research Study Groups:
This trial has the following groups:- Group 1: Hysterectomy and USLS
- Group 2: Hysteropexy
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any new participants able to take part in this trial?
"The clinicaltrial.gov website reveals that this trial is no longer recruiting new participants, with the first post being on April 1st 2013 and the last update made August 10th 2022. Despite not actively seeking patients, there are 78 other studies enrolling at present."
Answered by AI
How many North American locations are currently undertaking this scientific experiment?
"The University of Alabama at Birmingham, Department of Obstetrics and Gynecology in Birmingham, Duke University's Division of Urogynecology and Reconstructive Pelvic Surgery in Durham, North carolina, Brown/Women and Infants Hospital of Rhode island Center for Women’s Pelvic Medicine and Reconstructive Surgery in Providence are among the 8 other medical centres involved in this clinical trial."
Answered by AI
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