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Mesh

Surgical Treatments for Prolapse (ASPIRe Trial)

N/A

Waitlist Available

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

Women age 21 or older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6, 12, 24, 36, 48, and 60 months

Awards & highlights

ASPIRe Trial Summary

This trial will compare three different surgical treatments for women with a prolapsed uterus. The primary outcome is measured over time using a survival analysis approach, and the investigators hypothesize that mesh repairs will be superior to native tissue apical suspension.

Who is the study for?

This trial is for women over 21 with symptomatic vaginal prolapse after a hysterectomy, who feel a bulge or something falling out and want surgery. They must be able to follow up for up to 5 years. Those without a cervix but with significant vaginal cuff descent are eligible.Check my eligibility

What is being tested?

The study compares three surgical treatments for post-hysterectomy apical prolapse: transvaginal native tissue repair, sacral colpopexy using mesh (open, robotic, or laparoscopic), and Apical Transvaginal Mesh. It aims to see if there's a difference in treatment failure between the methods over time.See study design

What are the potential side effects?

Potential side effects may include discomfort at the surgery site, infection risk, bleeding complications, pain during intercourse, urinary problems or mesh erosion which could require additional interventions.

ASPIRe Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a woman aged 21 or older.

ASPIRe Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6, 12, 24, 36, 48, and 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6, 12, 24, 36, 48, and 60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6, 12, 24, 36, 48, and 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Surgical Treatment Success

Secondary outcome measures

Bowel function measured as the Colorectal-anal Distress Inventory (CRADI-8) scores (sub-scale of PFDI-20) in each treatment group

Cost of surgical procedures as measured by mean direct and indirect costs for participants in each treatment group.

Effect of treatment on how a woman feels (her perceptions and attitudes) about her body (Body Image) as measured by the mean score for each treatment group on the body image scale.

+25 more

ASPIRe Trial Design

3Treatment groups

Active Control

Group I: Transvaginal Native Tissue RepairActive Control1 Intervention

Transvaginal Native Tissue Repair: Sacrospinous Ligament Suspension (SSLS) and Uterosacral Ligament Suspension (USLS)

Group II: Sacral ColpopexyActive Control1 Intervention

Sacral Colpopexy performed via open, robotic, or laparoscopic procedure.

Group III: Apical Transvaginal Mesh RepairActive Control1 Intervention

Uphold™ LITE

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterOTHER

1,047 Previous Clinical Trials

1,053,436 Total Patients Enrolled

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

1,963 Previous Clinical Trials

2,674,378 Total Patients Enrolled

University of PittsburghOTHER

1,719 Previous Clinical Trials

16,341,978 Total Patients Enrolled

Media Library

Apical Transvaginal Mesh (Mesh) Clinical Trial Eligibility Overview. Trial Name: NCT02676973 — N/A

Visceral Prolapse Research Study Groups: Transvaginal Native Tissue Repair, Sacral Colpopexy, Apical Transvaginal Mesh Repair

Visceral Prolapse Clinical Trial 2023: Apical Transvaginal Mesh Highlights & Side Effects. Trial Name: NCT02676973 — N/A

Apical Transvaginal Mesh (Mesh) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02676973 — N/A

Visceral Prolapse Patient Testimony for trial: Trial Name: NCT02676973 — N/A

Frequently Asked Questions

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

Are there currently opportunities to join this research experiment?

"Clinicaltrials.gov states that this medical study has ceased to recruit patients, with its initial post on March 1st 2016 and the final edit on August 10th 2022. Nevertheless, 78 other trials are currently enrolling volunteers."

Answered by AI

In what locations is this experiment being supervised?

"Currently, 10 different locations are accepting participants for this trial - Durham, Birmingham and Albuquerque among them. It is recommended that one select the closest clinic to reduce transportation needs if they decide to join in."

Answered by AI