NCT00833001

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 126 (actual)
• Sponsor: Ethicon, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Cystocele
• Rectocele
• Enterocele

Interventions

Type	Name	Description
DEVICE	GYNECARE PROLIFT+M* Pelvic Floor Repair System	Pre-shaped mesh implants made of GYNECARE GYNEMESH M composite mesh, comprised of absorbable polyglecaprone 25 monofilament fiber and nonabsorbable polypropylene monofilament fiber

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-11-01
• Completion: 2011-12-01
• First posted: 2009-01-30
• Last updated: 2014-05-06

Locations

8 sites across 4 countries: Belgium, France, Germany, Netherlands