Clinical Performance of the GYNECARE PROLIFT + M* Pelvic Floor Repair System as a Device for Pelvic Organ Prolapse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00833001
Recruitment Status : Completed
First Posted : January 30, 2009
Last Update Posted : May 6, 2014
Information provided by (Responsible Party):
Ethicon, Inc.

Brief Summary:
The purpose of this study is to evaluate the clinical performance of the PROLIFT system with a new lighter-weight mesh in repair of vaginal prolapse.

Condition or disease Intervention/treatment
Cystocele Rectocele Enterocele Device: GYNECARE PROLIFT+M* Pelvic Floor Repair System

Detailed Description:
Vaginal prolapse (a feeling of bulge in the vagina) may cause some distressing symptoms such as loss of control of the bowel or bladder, and may also cause problems with women's sex life. There are a number of different surgical procedures which are used to repair prolapse. Sometimes a mesh is placed in the pelvis to support the weakened tissues. There is a lot of research going on to find the most suitable type of mesh to repair vaginal prolapse. The GYNECARE PROLIFT + M* Pelvic Floor Repair system is similar to a mesh already used for this procedure called ULTRAPRO*, but is lighter in weight. Currently, ULTRAPRO* is only approved for use in hernia repair and is not licensed for gynecological procedures. This study will be the first clinical investigation of this mesh in vaginal prolapse.

Study Type : Observational
Actual Enrollment : 126 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Multi-center Study to Evaluate the Clinical Performance of the GYNECARE PROLIFT + M* Pelvic Floor Repair System as a Device for Pelvic Organ Prolapse
Study Start Date : April 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
GYNECARE PROLIFT+M* Pelvic Floor Repair System
Device: GYNECARE PROLIFT+M* Pelvic Floor Repair System
Pre-shaped mesh implants made of GYNECARE GYNEMESH M composite mesh, comprised of absorbable polyglecaprone 25 monofilament fiber and nonabsorbable polypropylene monofilament fiber
Other Name: ULTRAPRO* mesh

Primary Outcome Measures :
  1. Pelvic Organ Prolapse Quantification (POP-Q) score [ Time Frame: 12 months post-procedure ]

Secondary Outcome Measures :
  1. Summary of treated compartment ICS POP-Q stage [ Time Frame: 3, 12, 24 and 36 months ]
  2. Proportion of subjects with the leading edge within the hymen and without further re-intervention for POP [ Time Frame: 12, 24 and 36 months ]
  3. Incidence of de novo prolapse (a post-operative prolapse)only in the untreated compartment, provided there was no pre-operative defect in that compartment [ Time Frame: Procedure to 36 months ]
  4. Mean scores and change from baseline in PFDI-20 scores, including sub scores (POPDI, CRADI and UDI [ Time Frame: 3, 12, 24 and 36 months ]
  5. Mean scores and change from baseline in PFIQ-7, including sub-scores (POPIQ, CRAIQ and UIQ). [ Time Frame: 3, 12, 24 and 36 months ]
  6. Days to return to normal activities (walking, driving, work, household activities and sexual intercourse) [ Time Frame: 1, 3, and 12 months ]
  7. Assessment of sexual function using PISQ-12 (mean scores and change from baseline) in subjects sexually active at baseline [ Time Frame: 12, 24 and 36 months ]
  8. Incidence of new onset dyspareunia, resolution or continuance of pre-existing dyspareunia [ Time Frame: Baseline to 36 months ]
  9. Adverse Events [ Time Frame: Procedure to 36 months ]
  10. Determination of any exposures/erosions including location [ Time Frame: Procedure to 36 months ]
  11. Summary of International Continence Society (ICS) Stages [ Time Frame: 3, 24, and 36 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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 III or IV, suitable for surgical repair.

Inclusion Criteria:

  • Candidates with symptomatic pelvic organ prolapse of ICS POP-Q Stage III or IV, suitable for surgical repair. Perineal repair, vaginal hysterectomy and/or mid urethral sling procedures for incontinence may be performed concurrently.
  • Age > or = 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 for POP repair concurrent to the Gynecare Prolift+M procedure (e.g. paravaginal repair, sacrocolpopexy, colporrhaphy in a non-Gynecare Prolift+M treated compartment).
  • 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 any pelvic radiation therapy.
  • History of chemotherapy within 6 months of the planned procedure.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00833001

Sint Lodewijkstraat 78
Genk, Belgium
CHRU de Lille
Lille, France, 59037
DRT Krankenhaus
Chemnitz, Germany, 09034
Martin Luther University
Halle, Germany, 06097
Hameln, Germany, 31785
Universitatsklinik Tubingen
Tubingen, Germany, 72076
St. Marien-Hospital
Vechta, Germany, D-49377
Reinier de Graaf Gasthuis
Delft, Netherlands
Sponsors and Collaborators
Ethicon, Inc.
Study Director: David Robinson, MD Ethicon, Inc.

Publications of Results:
Responsible Party: Ethicon, Inc. Identifier: NCT00833001     History of Changes
Other Study ID Numbers: 300-07-006
First Posted: January 30, 2009    Key Record Dates
Last Update Posted: May 6, 2014
Last Verified: May 2014

Keywords provided by Ethicon, Inc.:
Anterior vaginal prolapse (medial, lateral,apical cystocele)
Posterior vaginal prolapse (rectocele and/or enterocele)
Vault prolapse (enterocele, uterine/vaginal vault prolapse)

Additional relevant MeSH terms:
Pelvic Organ Prolapse
Pathological Conditions, Anatomical
Urinary Bladder Diseases
Urologic Diseases
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases