Clinical Performance of the GYNECARE PROLIFT + M* Pelvic Floor Repair System as a Device for Pelvic Organ Prolapse

Ethicon

Status: Completed

Conditions: Enterocele; Cystocele; Rectocele

Treatments: Device: GYNECARE PROLIFT+M* Pelvic Floor Repair System

Study type: Observational

Funder types: Industry

Identifiers

NCT00833001

300-07-006

Details and patient eligibility

About

The purpose of this study is to evaluate the clinical performance of the PROLIFT system with a new lighter-weight mesh in repair of vaginal prolapse.

Full description

Vaginal prolapse (a feeling of bulge in the vagina) may cause some distressing symptoms such as loss of control of the bowel or bladder, and may also cause problems with women's sex life. There are a number of different surgical procedures which are used to repair prolapse. Sometimes a mesh is placed in the pelvis to support the weakened tissues. There is a lot of research going on to find the most suitable type of mesh to repair vaginal prolapse. The GYNECARE PROLIFT + M* Pelvic Floor Repair system is similar to a mesh already used for this procedure called ULTRAPRO*, but is lighter in weight. Currently, ULTRAPRO* is only approved for use in hernia repair and is not licensed for gynecological procedures. This study will be the first clinical investigation of this mesh in vaginal prolapse.

Enrollment: 126 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.
• Age > or = 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 for POP repair concurrent to the Gynecare Prolift+M procedure (e.g. paravaginal repair, sacrocolpopexy, colporrhaphy in a non-Gynecare Prolift+M treated compartment).
• 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 any pelvic radiation therapy.
• History of chemotherapy within 6 months of the planned procedure.
• 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

126 participants in 1 patient group

1

Description:

GYNECARE PROLIFT+M\* Pelvic Floor Repair System

Treatment:

Device: GYNECARE PROLIFT+M* Pelvic Floor Repair System