GYNECARE PROSIMA* Pelvic Floor Repair System for Pelvic Organ Prolapse

Ethicon

Status: Completed

Conditions: Pelvic Organ Prolapse

Treatments: Device: GYNECARE PROSIMA* Pelvic Floor Repair System

Study type: Observational

Funder types: Industry

Identifiers

NCT00521066

300-06-005

Details and patient eligibility

About

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)

Full description

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

Enrollment: 150 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

150 participants in 1 patient group

1

Description:

Prosima Pelvic Floor Repair System

Treatment:

Device: GYNECARE PROSIMA* Pelvic Floor Repair System