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Prospective Analysis of Restorelle in the Treatment of Uterine Prolapse

NCT02921451•Michigan Institution of Women's Health PC

Summary

The purpose of this study is to determine the long term performance of Restorelle system for the treatment of uterine prolapse.

Detailed Description

This study is being done to evaluate the performance of the Restorelle system, which uses Smartmesh - an ultra-lightweight mesh for uterine prolapse management. Most patients undergo a hysterectomy i.e. removal of the uterus when they have a prolapse. However, this has often been found to be an unnecessary operation. The investigators are studying the use of the Restorelle mesh system to preserve the uterus when there is a uterine prolapse.

Eligibility

Age

18 - 90 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Subject is female.
•2. Subject is at least 18 years of age.
•3. Subjects who have already made the decision to proceed with uterine prolapse surgery using Restorelle Mesh.
•4. Subject has uterine prolapse defined by Prolapse Quantification System Assessment (POPQ) score of C -2 or greater.
•5. Subject reports a bothersome bulge they can see or feel per Pelvic Floor Distress Inventory Short Form 20 (PFDI-20) question 3, response of 2 or higher (i.e. response of "somewhat", "moderately" or "quite a bit").
•6. Subject is willing to provide written informed consent.
•7. Subject is willing and able to comply with follow-up regimen.

Exclusion Criteria

•1. Subject is pregnant or intends to become pregnant in the future.
•2. Subject has a history of pelvic organ cancer (e.g. uterine, ovarian, bladder or cervical).
•3. Subject has undergone any previous repair for pelvic organ prolapse.
•4. Subject has undergone a hysterectomy.
•5. Subject lacks competency of the English language.

Locations (1)

Advanced Urogynecology of Michigan, P.C.

Dearborn, Michigan, United States

Key Dates

Start Date

August 1, 2016

Primary Completion Date

August 1, 2020

Completion Date

August 1, 2020

Last Updated

August 14, 2019

Enrollment

ESTIMATED participants

Conditions

Uterine Prolapse

Interventions

Restorelle Smartmesh

DEVICE

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ENROLLING_BY_INVITATION

Laparoscopic Pectopexy and Laparoscopic Colporrhaphies in Pelvic Organ Prolapse Treatment

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 14, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Prospective Analysis of Restorelle in the Treatment of Uterine Prolapse

Inclusion Criteria

Exclusion Criteria

Performance of SYMMCORA® vs. V-Loc® Suture Material in Patients Undergoing Laparoscopic Total Hysterectomy

Laparoscopic Pectopexy and Laparoscopic Colporrhaphies in Pelvic Organ Prolapse Treatment

Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen

Lessons on Urethral Lidocaine in Urodynamics

Does a High BMI Affect Supervised Pelvic Floor Muscle Training for Improving Symptoms in Women With Various Stages of Pelvic Organ Prolapse?

Does Spinal Anesthesia for Prolapse Surgery With Lead to Urinary Retention?