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Clinical Performance of the GYNECARE PROLIFT + M* Pelvic Floor Repair System as a Device for Pelvic Organ Prolapse

Cystocele Clinical Trial

Official title:
A Prospective, Multi-center Study to Evaluate the Clinical Performance of the GYNECARE PROLIFT + M* Pelvic Floor Repair System as a Device for Pelvic Organ Prolapse

Clinical Trial Summary

The purpose of this study is to evaluate the clinical performance of the PROLIFT system with a new lighter-weight mesh in repair of vaginal prolapse.

Clinical Trial Description

Vaginal prolapse (a feeling of bulge in the vagina) may cause some distressing symptoms such as loss of control of the bowel or bladder, and may also cause problems with women's sex life. There are a number of different surgical procedures which are used to repair prolapse. Sometimes a mesh is placed in the pelvis to support the weakened tissues. There is a lot of research going on to find the most suitable type of mesh to repair vaginal prolapse. The GYNECARE PROLIFT + M* Pelvic Floor Repair system is similar to a mesh already used for this procedure called ULTRAPRO*, but is lighter in weight. Currently, ULTRAPRO* is only approved for use in hernia repair and is not licensed for gynecological procedures. This study will be the first clinical investigation of this mesh in vaginal prolapse. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00833001
Study type Observational
Source Ethicon, Inc.
Contact
Status Completed
Phase Phase 2/Phase 3
Start date April 2008
Completion date December 2011
View Details
See also
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