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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT00833001
First received: January 26, 2009
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Cystocele
Rectocele
Enterocele
Device: GYNECARE PROLIFT+M* Pelvic Floor Repair System
Phase 2
Phase 3

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Ethicon, Inc.:

Primary Outcome Measures:
  • Pelvic Organ Prolapse Quantification (POP-Q) score [ Time Frame: 12 months post-procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Summary of treated compartment ICS POP-Q stage [ Time Frame: 3, 12, 24 and 36 months ] [ Designated as safety issue: No ]
  • Proportion of subjects with the leading edge within the hymen and without further re-intervention for POP [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Mean scores and change from baseline in PFIQ-7, including sub-scores (POPIQ, CRAIQ and UIQ). [ Time Frame: 3, 12, 24 and 36 months ] [ Designated as safety issue: No ]
  • Days to return to normal activities (walking, driving, work, household activities and sexual intercourse) [ Time Frame: 1, 3, and 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Incidence of new onset dyspareunia, resolution or continuance of pre-existing dyspareunia [ Time Frame: Baseline to 36 months ] [ Designated as safety issue: Yes ]
  • Adverse Events [ Time Frame: Procedure to 36 months ] [ Designated as safety issue: Yes ]
  • Determination of any exposures/erosions including location [ Time Frame: Procedure to 36 months ] [ Designated as safety issue: Yes ]
  • Summary of International Continence Society (ICS) Stages [ Time Frame: 3, 24, and 36 months ] [ Designated as safety issue: No ]

Enrollment: 126
Study Start Date: April 2008
Study Completion Date: December 2011
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
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

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.

  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 III or IV, suitable for surgical repair.

Criteria

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.
  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: NCT00833001

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

Publications:
Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT00833001     History of Changes
Other Study ID Numbers: 300-07-006
Study First Received: January 26, 2009
Last Updated: May 5, 2014
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: German Institute of Medical Documentation and Information
Netherlands: Dutch Health Care Inspectorate

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:
Prolapse
Pelvic Organ Prolapse
Cystocele
Rectocele
Pathological Conditions, Anatomical
Urinary Bladder Diseases
Urologic Diseases
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 18, 2014