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

Ethicon, Inc.11 sites in 4 countries150 target enrollmentJune 2007

ConditionsPelvic Organ Prolapse

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pelvic Organ Prolapse
Sponsor: Ethicon, Inc.
Enrollment: 150
Locations: 11
Primary Endpoint: Success based on overall POP-Q score at 12 months post-procedure.
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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)

Detailed Description

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

Registry

clinicaltrials.gov

Start Date

June 2007

End Date

June 2010

Last Updated

11 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Ethicon, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Success based on overall POP-Q score at 12 months post-procedure.

Time Frame: 12-months

Success is determined by achievement of an overall POP-Q score of ICS Stage ≤1, without further re-intervention for POP.

Secondary Outcomes

Mean change from baseline in UIQ score(24 months)
EuroQol (EQ-5D health state) change from baseline(24 months)
Mean change from baseline in PISQ-12 score(24 months)
Success based on treated compartment ICS POP-Q stage(24 months)
Mean PFDI-20 score(24 months)
Mean change from baseline in PFDI-20 scores(12 months)
Mean change from baseline in POPDI score(24 months)
Mean change from baseline in CRADI score(24 months)
Mean CRAIQ score(24 months)
Mean PISQ-12 score(24 months)
Mean POPIQ score(24 months)
Discomfort of balloon removal, measured using VAS at time of removal.(24 hrs post-surgical)
Subject perception of VSD: Awareness(3-4 week visit)
Success based on overall POP-Q score at 24 months post-procedure.(24 months)
Success defined as the leading edge within the hymen(24 months)
Mean change from baseline in CRAIQ score(24 months)
Mean UIQ score(24 months)
Mean POPDI score(24 months)
Mean UDI score(24 months)
Mean change from baseline in UDI score(24 months)
Mean PFIQ-7 score(24 months)
Mean change from baseline in PFIQ-7 score(24 months)
Subject perception of VSD: Discomfort(3-4 week visit)
Mean CRADI score(24 months)
Mean change from baseline in POPIQ score(24 months)
Pain score measured using Visual Analog Scale (VAS).(24 hours post surgery and at the 3-4 week visit)
Incidence of new onset dyspareunia, resolution or continuance of pre-existing dyspareunia(ongoing)
Length of procedure(perioperative)
Subject perception of VSD: Acceptability of discharge(3-4 week visit)
Subject global impression(24 month visit)