NL-OMON31625
Completed
Not Applicable
A Prospective, Multi-centre Study to Evaluate the Clinical Performance of the GYNECARE PROLIFT +M* Pelvic Floor Repair System as a Device for Pelvic Organ Prolapse - The GYNECARE PROLIFT
Ethicon_Johnson & Johnson Medical Ltd0 sites20 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prolapse
- Sponsor
- Ethicon_Johnson & Johnson Medical Ltd
- Enrollment
- 20
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. 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.
- •2\. Age \>\<\= 18 years.
- •3\. 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 Criteria
- •1\. Additional surgical intervention for POP repair concurrent to the Gynecare Prolift \+M procedure (e.g. paravaginal repair, sacrocolpopexy, colporrophy in a non\-Gynecare Prolift\+M treated compartment).
- •2\. Previous repair of pelvic organ prolapse involving insertion of mesh.
- •3\. Previous hysterectomy within 6 months of scheduled surgery.
- •4\. Experimental drug or experimental medical device within 3 months prior to the planned procedure.
- •5\. 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.
- •6\. Coagulation disorder or on therapeutic anticoagulant therapy at the time of surgery.
- •7\. History of chemotherapy or pelvic radiation therapy.
- •8\. Systemic disease known to affect bladder or bowel function (e.g. Parkinson\*s disease, multiple sclerosis, spina bifida, spinal cord injury or trauma).
- •9\. Current evaluation or treatment for chronic pelvic pain (e.g. interstitial cystitis, endometriosis, coccydynia, vulvadynia).
- •10\. Nursing or pregnant or intends future pregnancy.
Outcomes
Primary Outcomes
Not specified
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