GYNECARE PROSIMA* Pelvic Floor Repair System for Pelvic Organ Prolapse

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT00521066
First received: August 24, 2007
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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)


Condition Intervention
Pelvic Organ Prolapse
Device: GYNECARE PROSIMA* Pelvic Floor Repair System

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ethicon, Inc.:

Primary Outcome Measures:
  • Success based on overall POP-Q score at 12 months post-procedure. [ Time Frame: 12-months ] [ Designated as safety issue: No ]
    Success is determined by achievement of an overall POP-Q score of ICS Stage ≤1, without further re-intervention for POP.


Secondary Outcome Measures:
  • Success based on overall POP-Q score at 24 months post-procedure. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Success is determined by achievement of an overall POP-Q score of ICS Stage ≤1, without further re-intervention for POP

  • Success based on treated compartment ICS POP-Q stage [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Success will be determined by achievement of treated compartment POP-Q score of ICS Stage ≤1, without further re-intervention for POP.

  • Success based on treated compartment ICS POP-Q stage [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Success will be determined by achievement of treated compartment POP-Q score of ICS Stage ≤1, without further re-intervention for POP.

  • Success defined as the leading edge within the hymen [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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)

  • Success defined as the leading edge within the hymen [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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)

  • Mean PFDI-20 score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Mean PFDI-20 score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Mean change from baseline in PFDI-20 scores [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Mean change from baseline in PFDI-20 scores [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Mean POPDI score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    POPDI is a sub score of PFDI-20

  • Mean POPDI score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    POPDI is a sub score of PFDI-20

  • Mean change from baseline in POPDI score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    POPDI is a sub scores of PFDI-20

  • Mean change from baseline in POPDI score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    POPDI is a sub score of PFDI-20

  • Mean CRADI score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    CRADI is a sub score of PFDI-20

  • Mean CRADI score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    CRADI is a sub score of PFDI-20

  • Mean change from baseline in CRADI score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    CRADI is a sub score of PFDI-20

  • Mean change from baseline in CRADI score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    CRADI is a sub score of PFDI-20

  • Mean UDI score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    UDI is a sub score of PFDI-20

  • Mean UDI score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    UDI is a sub score of PFDI-20

  • Mean change from baseline in UDI score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    UDI is a sub score of PFDI-20

  • Mean change from baseline in UDI score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    UDI is a sub score of PFDI-20

  • EuroQol (EQ-5D health state) change from baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • EuroQol (EQ-5D health state) change from baseline [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Mean PFIQ-7 score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Mean PFIQ-7 score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Mean change from baseline in PFIQ-7 score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Mean change from baseline in PFIQ-7 score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Mean POPIQ score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    POPIQ is a sub-score of PFIQ-7

  • Mean POPIQ score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    POPIQ is a sub-score of PFIQ-7

  • Mean change from baseline in POPIQ score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    POPIQ is a sub-score of PFIQ-7

  • Mean change from baseline in POPIQ score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    POPIQ is a sub-score of PFIQ-7

  • Mean CRAIQ score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    CRAIQ is a sub-score of PFIQ-7

  • Mean CRAIQ score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    CRAIQ is a sub-score of PFIQ-7

  • Mean change from baseline in CRAIQ score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    CRAIQ is a sub-score of PFIQ-7

  • Mean change from baseline in CRAIQ score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    CRAIQ is a sub-score of PFIQ-7

  • Mean UIQ score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    UIQ is a sub-score of PFIQ-7

  • Mean UIQ score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    UIQ is a sub-score of PFIQ-7

  • Mean change from baseline in UIQ score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    UIQ is a sub-score of PFIQ-7

  • Mean change from baseline in UIQ score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    UIQ is a sub-score of PFIQ-7

  • Mean PISQ-12 score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    In subjects sexually active at baseline, assessment of sexual function

  • Mean PISQ-12 score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    In subjects sexually active at baseline, assessment of sexual function

  • Mean change from baseline in PISQ-12 score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    In subjects sexually active at baseline, assessment of sexual function

  • Mean change from baseline in PISQ-12 score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    In subjects sexually active at baseline, assessment of sexual function

  • Incidence of new onset dyspareunia, resolution or continuance of pre-existing dyspareunia [ Time Frame: ongoing ] [ Designated as safety issue: Yes ]
  • Length of procedure [ Time Frame: perioperative ] [ Designated as safety issue: Yes ]
    From time to first incision to time of last suture used to secure VSD

  • Pain score measured using Visual Analog Scale (VAS). [ Time Frame: 24 hours post surgery and at the 3-4 week visit ] [ Designated as safety issue: Yes ]
  • Discomfort of balloon removal, measured using VAS at time of removal. [ Time Frame: 24 hrs post-surgical ] [ Designated as safety issue: Yes ]
  • Subject perception of VSD: Awareness [ Time Frame: 3-4 week visit ] [ Designated as safety issue: No ]
    Measured by visual analogue scale

  • Subject perception of VSD: Discomfort [ Time Frame: 3-4 week visit ] [ Designated as safety issue: No ]
    Measured by visual analogue scale

  • Subject perception of VSD: Acceptability of discharge [ Time Frame: 3-4 week visit ] [ Designated as safety issue: No ]
    Measured by visual analogue scale

  • Subject global impression [ Time Frame: 12 month visit ] [ Designated as safety issue: No ]
    assessed on a 5 point Likert scale

  • Subject global impression [ Time Frame: 24 month visit ] [ Designated as safety issue: No ]
    assessed on a 5 point Likert scale


Enrollment: 150
Study Start Date: June 2007
Study Completion Date: June 2010
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Prosima Pelvic Floor Repair System
Device: GYNECARE PROSIMA* Pelvic Floor Repair System
procedure for pelvic organ prolapse
Other Name: mesh pelvic floor repari

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00521066

Locations
United States, Florida
Specialists in Urology
Naples, Florida, United States, 34102
United States, Michigan
Female Pelvic Medicine and Urogynecology Institute of Michigan
Dearborn, Michigan, United States, 48124
Female Pelvic Medicine & Urogynecology
Grand Rapids, Michigan, United States, 49506
United States, Pennsylvania
The Institute for Female Pelvic Medicine & Reconstructive Surgery
Allentown, Pennsylvania, United States, 18104
Magee Women's Hospital of the Universtiy of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Australia
Royal Women's Hospital
Melbourne, Australia, 3053
Germany
Bereich Urogynakologie
Halle, Germany, 06097
Universitatsklinik Tubingen
Tubingen, Germany, 72076
United Kingdom
Addenbrookes Hospital
Cambridge, United Kingdom, CB2 0QQ
North Hampshire Hospital
Hampshire, United Kingdom, RG24 9NA
St. Mary's Hospital
Manchester, United Kingdom, M13 0JH
Sponsors and Collaborators
Ethicon, Inc.
Investigators
Study Director: David Robinson, M.D. Ethicon, Inc.
  More Information

Publications:
Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT00521066     History of Changes
Other Study ID Numbers: 300-06-005
Study First Received: August 24, 2007
Last Updated: May 5, 2014
Health Authority: United States: Institutional Review Board
United Kingdom: Research Ethics Committee
Germany: Ethics Commission
Australia: Human Research Ethics Committee

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 16, 2014