GYNECARE PROSIMA* Pelvic Floor Repair System for Pelvic Organ Prolapse

Completed

• Conditions: Pelvic Organ Prolapse

• Registration Number: NCT00521066
• Lead Sponsor: Ethicon, Inc.

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.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-08-24
• Study First Submitted QC: 2007-08-24
• Study First Posted: 2007-08-27
• Primary Completion: 2008-10
• Study Completion: 2010-06
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-05
• Last Update Posted: 2014-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Success based on overall POP-Q score at 12 months post-procedure.	12-months	Success is determined by achievement of an overall POP-Q score of ICS Stage ≤1, without further re-intervention for POP.

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline in PISQ-12 score	24 months	In subjects sexually active at baseline, assessment of sexual function
Success based on treated compartment ICS POP-Q stage	24 months	Success will be determined by achievement of treated compartment POP-Q score of ICS Stage ≤1, without further re-intervention for POP.
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	POPDI is a sub score of PFDI-20
Mean change from baseline in CRADI score	24 months	CRADI is a sub score of PFDI-20
Mean CRAIQ score	24 months	CRAIQ is a sub-score of PFIQ-7
Mean PISQ-12 score	24 months	In subjects sexually active at baseline, assessment of sexual function
Mean POPIQ score	24 months	POPIQ is a sub-score of PFIQ-7
Mean change from baseline in UIQ score	24 months	UIQ is a sub-score of PFIQ-7
Discomfort of balloon removal, measured using VAS at time of removal.	24 hrs post-surgical
Subject perception of VSD: Awareness	3-4 week visit	Measured by visual analogue scale
Success based on overall POP-Q score at 24 months post-procedure.	24 months	Success is determined by achievement of an overall POP-Q score of ICS Stage ≤1, without further re-intervention for POP
Success defined as the leading edge within the hymen	24 months	Success defined as the leading edge within the hymen (i.e. all POP-Q values to be less than 0, without further re-intervention for POP)
EuroQol (EQ-5D health state) change from baseline	24 months
Mean change from baseline in CRAIQ score	24 months	CRAIQ is a sub-score of PFIQ-7
Mean UIQ score	24 months	UIQ is a sub-score of PFIQ-7
Mean POPDI score	24 months	POPDI is a sub score of PFDI-20
Mean UDI score	24 months	UDI is a sub score of PFDI-20
Mean change from baseline in UDI score	24 months	UDI is a sub score of PFDI-20
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	Measured by visual analogue scale
Mean CRADI score	24 months	CRADI is a sub score of PFDI-20
Mean change from baseline in POPIQ score	24 months	POPIQ is a sub-score of PFIQ-7
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	From time to first incision to time of last suture used to secure VSD
Subject perception of VSD: Acceptability of discharge	3-4 week visit	Measured by visual analogue scale
Subject global impression	24 month visit	assessed on a 5 point Likert scale

Trial Locations

Locations (11)

Specialists in Urology; 🇺🇸 Naples, Florida, United States

Female Pelvic Medicine and Urogynecology Institute of Michigan; 🇺🇸 Dearborn, Michigan, United States

Female Pelvic Medicine & Urogynecology; 🇺🇸 Grand Rapids, Michigan, United States

The Institute for Female Pelvic Medicine & Reconstructive Surgery; 🇺🇸 Allentown, Pennsylvania, United States

Magee Women's Hospital of the Universtiy of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Royal Women's Hospital; 🇦🇺 Melbourne, Australia

Bereich Urogynakologie; 🇩🇪 Halle, Germany

Universitatsklinik Tubingen; 🇩🇪 Tubingen, Germany

Addenbrookes Hospital; 🇬🇧 Cambridge, United Kingdom

North Hampshire Hospital; 🇬🇧 Hampshire, United Kingdom

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