Prospective Analysis of Restorelle in the Treatment of Uterine Prolapse

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2020-08-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Uterine Prolapse

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Restorelle Smartmesh

Surgical procedure for treatment of uterine prolapse will use the device, Restorelle Smartmesh.

Group Type OTHER

Restorelle Smartmesh

Intervention Type DEVICE

Patients will have surgery using the device, Restorelle Smartmesh, for treatment of uterine prolapse.

Interventions

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Restorelle Smartmesh

Patients will have surgery using the device, Restorelle Smartmesh, for treatment of uterine prolapse.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No