GYNECARE PROSIMA* Pelvic Floor Repair System for Pelvic Organ Prolapse

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

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)

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Device: GYNECARE PROSIMA* Pelvic Floor Repair System

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Australia
  • Melbourne, Australia, 3053
    • Royal Women's Hospital
• Germany
  • Halle, Germany, 06097
    • Bereich Urogynakologie
  • Tubingen, Germany, 72076
    • Universitätsklinik Tübingen
• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Addenbrookes Hospital
  • Hampshire, United Kingdom, RG24 9NA
    • North Hampshire Hospital
  • Manchester, United Kingdom, M13 0JH
    • St. Mary's Hospital
• United States
  • Florida
    • Naples, Florida, United States, 34102
      • Specialists in Urology
  • Michigan
    • Dearborn, Michigan, United States, 48124
      • Female Pelvic Medicine and Urogynecology Institute of Michigan
    • Grand Rapids, Michigan, United States, 49506
      • Female Pelvic Medicine & Urogynecology
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • The Institute for Female Pelvic Medicine & Reconstructive Surgery
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee Women's Hospital of the Universtiy of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women over 18 with symptomatic pelvic organ prolapse of ICS POP-Q Stage II or III, suitable for surgical repair

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; Prosima Pelvic Floor Repair System	Device: GYNECARE PROSIMA* Pelvic Floor Repair System; procedure for pelvic organ prolapse; Other Names: mesh pelvic floor repari

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score measured using Visual Analog Scale (VAS).		24 hours post surgery and at the 3-4 week visit
Success based on overall POP-Q score at 24 months post-procedure.	Success is determined by achievement of an overall POP-Q score of ICS Stage ≤1, without further re-intervention for POP	24 months
Success based on treated compartment ICS POP-Q stage	Success will be determined by achievement of treated compartment POP-Q score of ICS Stage ≤1, without further re-intervention for POP.	12 months
Success based on treated compartment ICS POP-Q stage	Success will be determined by achievement of treated compartment POP-Q score of ICS Stage ≤1, without further re-intervention for POP.	24 months
Success defined as the leading edge within the hymen	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)	12 months
Success defined as the leading edge within the hymen	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)	24 months
Mean PFDI-20 score		12 months
Mean PFDI-20 score		24 months
Mean change from baseline in PFDI-20 scores		24 months
Mean change from baseline in PFDI-20 scores		12 months
Mean POPDI score	POPDI is a sub score of PFDI-20	12 months
Mean POPDI score	POPDI is a sub score of PFDI-20	24 months
Mean change from baseline in POPDI score	POPDI is a sub scores of PFDI-20	12 months
Mean change from baseline in POPDI score	POPDI is a sub score of PFDI-20	24 months
Mean CRADI score	CRADI is a sub score of PFDI-20	12 months
Mean CRADI score	CRADI is a sub score of PFDI-20	24 months
Mean change from baseline in CRADI score	CRADI is a sub score of PFDI-20	12 months
Mean change from baseline in CRADI score	CRADI is a sub score of PFDI-20	24 months
Mean UDI score	UDI is a sub score of PFDI-20	12 months
Mean UDI score	UDI is a sub score of PFDI-20	24 months
Mean change from baseline in UDI score	UDI is a sub score of PFDI-20	12 months
Mean change from baseline in UDI score	UDI is a sub score of PFDI-20	24 months
EuroQol (EQ-5D health state) change from baseline		12 months
EuroQol (EQ-5D health state) change from baseline		24 months
Mean PFIQ-7 score		12 months
Mean PFIQ-7 score		24 months
Mean change from baseline in PFIQ-7 score		12 months
Mean change from baseline in PFIQ-7 score		24 months
Mean POPIQ score	POPIQ is a sub-score of PFIQ-7	12 months
Mean POPIQ score	POPIQ is a sub-score of PFIQ-7	24 months
Mean change from baseline in POPIQ score	POPIQ is a sub-score of PFIQ-7	12 months
Mean change from baseline in POPIQ score	POPIQ is a sub-score of PFIQ-7	24 months
Mean CRAIQ score	CRAIQ is a sub-score of PFIQ-7	12 months
Mean CRAIQ score	CRAIQ is a sub-score of PFIQ-7	24 months
Mean change from baseline in CRAIQ score	CRAIQ is a sub-score of PFIQ-7	12 months
Mean change from baseline in CRAIQ score	CRAIQ is a sub-score of PFIQ-7	24 months
Mean UIQ score	UIQ is a sub-score of PFIQ-7	12 months
Mean UIQ score	UIQ is a sub-score of PFIQ-7	24 months
Mean change from baseline in UIQ score	UIQ is a sub-score of PFIQ-7	12 months
Mean change from baseline in UIQ score	UIQ is a sub-score of PFIQ-7	24 months
Mean PISQ-12 score	In subjects sexually active at baseline, assessment of sexual function	12 months
Mean PISQ-12 score	In subjects sexually active at baseline, assessment of sexual function	24 months
Mean change from baseline in PISQ-12 score	In subjects sexually active at baseline, assessment of sexual function	12 months
Mean change from baseline in PISQ-12 score	In subjects sexually active at baseline, assessment of sexual function	24 months
Incidence of new onset dyspareunia, resolution or continuance of pre-existing dyspareunia		ongoing
Length of procedure	From time to first incision to time of last suture used to secure VSD	perioperative
Discomfort of balloon removal, measured using VAS at time of removal.		24 hrs post-surgical
Subject perception of VSD: Awareness	Measured by visual analogue scale	3-4 week visit
Subject perception of VSD: Discomfort	Measured by visual analogue scale	3-4 week visit
Subject perception of VSD: Acceptability of discharge	Measured by visual analogue scale	3-4 week visit
Subject global impression	assessed on a 5 point Likert scale	12 month visit
Subject global impression	assessed on a 5 point Likert scale	24 month visit

Collaborators and Investigators

• Sponsor: Ethicon, Inc.

Publications and helpful links

General Publications

• Zyczynski HM, Carey MP, Smith AR, Gauld JM, Robinson D, Sikirica V, Reisenauer C, Slack M; Prosima Study Investigators. One-year clinical outcomes after prolapse surgery with nonanchored mesh and vaginal support device. Am J Obstet Gynecol. 2010 Dec;203(6):587.e1-8. doi: 10.1016/j.ajog.2010.08.001.
• Sayer T, Lim J, Gauld JM, Hinoul P, Jones P, Franco N, Van Drie D, Slack M; Prosima Study Investigators. Medium-term clinical outcomes following surgical repair for vaginal prolapse with tension-free mesh and vaginal support device. Int Urogynecol J. 2012 Apr;23(4):487-93. doi: 10.1007/s00192-011-1600-3. Epub 2011 Dec 6.

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: August 24, 2007
• First Submitted That Met QC Criteria: August 24, 2007
• First Posted (Estimate): August 27, 2007

Study Record Updates

• Last Update Posted (Estimate): May 6, 2014
• Last Update Submitted That Met QC Criteria: May 5, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: 300-06-005