GYNECARE PROSIMA* Pelvic Floor Repair System for Pelvic Organ Prolapse

A Prospective, Multi-centre Study to Evaluate the Clinical Performance of the GYNECARE PROSIMA* Pelvic Floor Repair System as a Procedure for Pelvic Organ Prolapse

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)

The GYNECARE PROSIMA* system provides a simplified mesh repair, avoiding the need for dissection outside the pelvic cavity.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.