Clinical Performance of GYNECARE PROSIMA* Pelvic Floor Repair System for Symptomatic Pelvic Organ Prolapse

Peking Union Medical College Hospital150 enrolled

Overview

The purpose of this study is to evaluate the safety and effectiveness of the GYNECARE PROSIMA\* Pelvic Floor Repair System as a Device in Women with Symptomatic Pelvic Organ Prolapse.

The GYNECARE PROSIMA\* system is a new technique and now available in China. It provides a simplified unanchored mesh repair, making surgery much simpler to perform and reduces the risk of the specific complications that may occur when tunneling devices beyond the pelvic cavity. In clinical practice, many women have symptomatic prolapse, which requires surgical correction. They are relatively young, and therefore care more about the long-term outcomes and quality of life after procedure. The purpose of this multicenter and prospective study is to evaluate the effectiveness and safety of the GYNECARE PROSIMA\* system in the treatment of symptomatic POP-Q Stage II-III pelvic organ prolapse.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Pelvic Organ Prolapse Stage II-III

Interventions

Procedure: GYNECARE PROSIMA* Pelvic Floor Repair SystemPROCEDURE

Perform surgery with GYNECARE PROSIMA\* Pelvic Floor Repair System. Vaginal hysterectomy or mid-urethral sling procedure for incontinence could be performed concurrently.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Candidates with symptomatic pelvic organ prolapse of ICS POP-Q Stage II or III, suitable for surgical repair. Vaginal hysterectomy and 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 approved informed consent. Exclusion Criteria: * Additional surgical intervention concurrent to the 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, 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. * Chronic cough not well-controlled. * BMI≥30. * 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.