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
- Conditions
- Prolapse1004682810029903
- Registration Number
- NL-OMON31625
- Lead Sponsor
- Ethicon_Johnson & Johnson Medical Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
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.
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.
11. 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>There will be one primary effectiveness end-point:<br /><br>* POP-Q score at 12 months post-procedure. Success will be determined by<br /><br>achievement of a POP-Q score of ICS Stage *1, without further surgical<br /><br>re-intervention for POP. </p><br>
- Secondary Outcome Measures
Name Time Method