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GYNECARE PROSIMA* Pelvic Floor Repair System for Pelvic Organ Prolapse
This study is currently recruiting participants.
Verified by Ethicon, Inc., August 2007
Sponsored by: Ethicon, Inc.
Information provided by: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT00521066
  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

MedlinePlus related topics: Pelvic Support Problems
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Ethicon, Inc.:

Primary Outcome Measures:
  • POP-Q score at 12 months post-procedure. [ Time Frame: 12-months ]

Secondary Outcome Measures:
  • Summary of ICS Stages at 6 month visit.
  • Summary of treated compartment ICS POP-Q stage at 6 and 12 months.
  • Success at 12 months, defined as the leading edge within the hymen
  • Mean scores and change from baseline in PFDI-20 scores at 6 and 12 month visits including sub scores (POPDI, CRADI and UDI).
  • Date of return to normal activities
  • EuroQol (EQ-5D health state) change from baseline at 6 and 12 months visit.
  • Mean scores and change from baseline in PFIQ-7 at 6 and 12 months visit including sub scores (POPIQ, CRAIQ and UIQ).
  • In subjects sexually active at baseline, assessment of sexual function using PISQ-12 assessed at 6 and 12 month visits (mean scores and change from baseline).
  • Incidence of new onset dyspareunia, resolution or continuance of pre-existing dyspareunia
  • Total time in the operating room.
  • Length of procedure
  • Nights in hospital
  • Pain score 24 hours post surgery and at the 3-4 week visit, measured using Visual Analog Scale (VAS).
  • Discomfort of balloon removal, measured using VAS at time of removal.
  • Subject perception of VSD by VAS at 3-4 week visit, assessing incidence of VSD displacement.
  • Balloon performance as measured by inflation volume at time of removal versus original volume used for balloon inflation.
  • Subject global impression assessed on a 5 point Likert scale at 6 and 12 month visit.
  • Comparison of POP-Q success rates in DRI versus non-DRI subjects.
  • Assessment of vaginal mesh placement using 3-D ultrasound scanning

Estimated Enrollment: 160
Study Start Date: June 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
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, vulvadynia).
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00521066

Contacts
Contact: Judith Gauld, BSc (Hons) +44 150 659 4679 jgauld@ethgb.jnj.com

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

Study ID Numbers: 300-06-005
Study First Received: August 24, 2007
Last Updated: April 11, 2008
ClinicalTrials.gov Identifier: NCT00521066  
Health Authority: United States: Institutional Review Board;   United Kingdom: Research Ethics Committee;   Germany: Ethics Commission;   Australia: Human Research Ethics Committee

Study placed in the following topic categories:
Pathological Conditions, Anatomical
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Prolapse
Rectal Prolapse

ClinicalTrials.gov processed this record on January 16, 2009