GYNECARE PROSIMA* Pelvic Floor Repair System for Pelvic Organ Prolapse

Completed

Conditions studied: Pelvic Organ Prolapse

In brief

The purpose of this study is to is to evaluate the success of the GYNECARE PROSIMA\* system in women with symptoms for pelvic organ prolapse (POP) requiring surgical correction of POP. (\*TRADEMARK)

Key facts

Study ID

NCT00521066

Run by

Ethicon, Inc.

People needed

150

Starts

2007-06-01

Expected to finish

2010-06-01

Last updated by the study team

2014-05-06

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Candidates with symptomatic pelvic organ prolapse of ICS POP-Q Stage II or III, suitable for surgical repair. Vaginal hysterectomy, perineal repair and/or mid urethral sling procedures for incontinence may be performed concurrently.
• Age ≥ 18 years.
• Agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires, and documents this agreement by signing the Ethics Committee / IRB approved informed consent.

You may not qualify if…

• Additional surgical intervention concurrent to the PROSIMA procedure (e.g. sacrocolpopexy, paravaginal repair, tubal sterilisation).
• Previous repair of pelvic organ prolapse involving insertion of mesh.
• Previous hysterectomy within 6 months of scheduled surgery.
• Experimental drug or experimental medical device within 3 months prior to the planned procedure.
• Active genital, urinary or systemic infection at the time of the surgical procedure. Surgery may be delayed in such subjects until the infection is cleared.
• Coagulation disorder or on therapeutic anticoagulant therapy at the time of surgery.
• History of chemotherapy or pelvic radiation therapy.
• Systemic disease known to affect bladder or bowel function (e.g. Parkinson's disease, multiple sclerosis, spina bifida, spinal cord injury or trauma).
• Current evaluation or treatment for chronic pelvic pain (e.g. interstitial cystitis, endometriosis, coccydynia, vulvodynia).
• Nursing or pregnant or intends future pregnancy.
• In the investigator's opinion, any medical condition or psychiatric illness that could potentially be life threatening or affect their ability to complete the study visits according to this protocol.

Where it is running

• Specialists in Urology — Naples, Florida, United States
• Female Pelvic Medicine and Urogynecology Institute of Michigan — Dearborn, Michigan, United States
• Female Pelvic Medicine & Urogynecology — Grand Rapids, Michigan, United States
• The Institute for Female Pelvic Medicine & Reconstructive Surgery — Allentown, Pennsylvania, United States
• Magee Women's Hospital of the Universtiy of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Royal Women's Hospital — Melbourne, Australia
• Bereich Urogynakologie — Halle, Germany
• Universitatsklinik Tubingen — Tübingen, Germany
• Addenbrookes Hospital — Cambridge, United Kingdom
• North Hampshire Hospital — Hampshire, United Kingdom
• St. Mary's Hospital — Manchester, United Kingdom

Full record on ClinicalTrials.gov

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