Clinical Assessment of the Total Vaginal Mesh Technique for Treatment of Genital 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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2005-11-30

Brief Summary

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Pelvic floor prolapse is a general term used to describe various clinical conditions that are associated with pelvic floor (muscles that support the vagina) relaxation in female patients.Pelvic floor prolapse is thought to result from a stretching, weakening or tearing of the soft tissue structures that support the pelvic organs. These tissues become compromised because of a weakened or damaged.The purpose of the study will be to demonstrate the usability of Polypropylene Mesh for prolapse repair, using the TVM technique.

Detailed Description

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Conditions

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Vaginal Prolapse

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Polypropylene Mesh

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Female candidate for surgical pelvic floor repair (at least ICS stage II symptomatic prolapse).
* Patient who is at leat 21 years of age.
* Patient whose family is complete.
* Patient may not have uncontrolled diabetes.

Exclusion Criteria

* Patients may not have coagulation disorders.

Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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Martin Weisberg, MD

Role: STUDY_DIRECTOR

Ethicon, Inc.

Countries

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United States

Other Identifiers

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2003-016

Identifier Type: -

Identifier Source: org_study_id