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 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年5月13日

适应症

试验速览

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•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.

发起方

Ethicon_Johnson & Johnson Medical Ltd