Status:
COMPLETED
Clinical Performance of the GYNECARE PROLIFT + M* Pelvic Floor Repair System as a Device for Pelvic Organ Prolapse
Lead Sponsor:
Ethicon, Inc.
Conditions:
Cystocele
Rectocele
Eligibility:
FEMALE
18+ years
Brief 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 ...
Eligibility Criteria
Inclusion
- Candidates with symptomatic pelvic organ prolapse of ICS POP-Q Stage III or IV, suitable for surgical repair. Perineal repair, vaginal hysterectomy and/or mid urethral sling procedures for incontinence may be performed concurrently.
- Age \> or = 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.
Exclusion
- Additional surgical intervention for POP repair concurrent to the Gynecare Prolift+M procedure (e.g. paravaginal repair, sacrocolpopexy, colporrhaphy in a non-Gynecare Prolift+M treated compartment).
- 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 any pelvic radiation therapy.
- History of chemotherapy within 6 months of the planned procedure.
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT00833001
Start Date
April 1 2008
End Date
December 1 2011
Last Update
May 6 2014
Active Locations (8)
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1
Sint Lodewijkstraat 78
Genk, Belgium
2
CHRU de Lille
Lille, France, 59037
3
DRT Krankenhaus
Chemnitz, Germany, 09034
4
Martin Luther University
Halle, Germany, 06097