Prospective Analysis of Restorelle in the Treatment of Uterine Prolapse

August 12, 2019 updated by: Salil Khandwala, Michigan Institution of Women's Health PC
The purpose of this study is to determine the long term performance of Restorelle system for the treatment of uterine prolapse.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Michigan
      • Dearborn, Michigan, United States, 48125
        • Advanced Urogynecology of Michigan, P.C.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Restorelle Smartmesh
Surgical procedure for treatment of uterine prolapse will use the device, Restorelle Smartmesh.
Patients will have surgery using the device, Restorelle Smartmesh, for treatment of uterine prolapse.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients who present with recurrence of uterine prolapse following surgery as assessed by failing to meet success criteria
Time Frame: Within first two years after surgical procedure
Success criteria will be defined through the examination of patient's Prolapse Quantification System Assessment (POPQ) score of C -1 or less and patient's report of bothersome bulge they can see or feel per Pelvic Floor Distress Inventory Short Form 20 (PFDI-20) question 3, response of 0 or 1 (i.e. response of "not at all"). Failure to meet this criteria will be considered recurrence of uterine prolapse.
Within first two years after surgical procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Salil Khandwala, Advanced Urogynecology of Michigan, P.C.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

August 1, 2020

Study Completion (Anticipated)

August 1, 2020

Study Registration Dates

First Submitted

September 23, 2016

First Submitted That Met QC Criteria

September 29, 2016

First Posted (Estimate)

October 3, 2016

Study Record Updates

Last Update Posted (Actual)

August 14, 2019

Last Update Submitted That Met QC Criteria

August 12, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • IISP 16-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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