Comparative Study of Mesh Versus No Mesh in Prolapse Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Centre Hospitalier Universitaire de Nīmes.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
DRRC
Sofradim Corporation
Information provided by:
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT00153257
First received: September 8, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

Hypothesis / aims of study A RCT has shown that results of prolapse repair via vaginal approach could be improved when a polypropylene mesh is used as tissue support (1). However, non protected heavy-weight meshes were associated with a high rate of local complications such as vaginal erosions and dyspareunia (2). The aim of this multicentre study is to evaluate anatomical and functional results of an innovative low-weight polypropylene mesh protected by an absorbable hydrophilic film in the prolapse repair by vaginal route, in comparison by the standard anterior colporrhaphy.

Study design, materials and methods This study involves 15 centres in French Private or Public Hospital. Patients will be randomly allocated to be operated by a standard anterior colporrhaphy or by an anterior repair reinforced by a specially designed mesh: UgytexTM (Sofradim, France). Ugytex is a low-weight (38g/m²) and highly porous (average porosity: 89%, pores over 1.5mm) polypropylene monofilament mesh offering tissue ingrowth and connective differentiation for a stable and long-term support. The mesh is coated with a hydrophilic film composed of atelocollagen, polyethylene glycol and glycerol. The absorbable coating protects delicate pelvic viscera from the risk of acute inflammation during the healing’s inflammatory peak. Prolapse severity will be evaluated using the POP-Q system. In order to evaluate the patient’s quality of life, the validated PFDI and the PFIQ questionnaires will be used preoperatively and during follow-up (3), as well as a validated questionnaire on sexual problems. The difference on one-year cure rate should be 15% (80% for the anterior colporrhaphy and 95% for the mesh repair). Then the estimated number of patient is 97 in each arm.

  1. Julian TM: The efficacy or Marlex mesh in the repair of severe, recurrent vaginal prolapse of the anterior mid-vaginal wall. Am J Obstet Gynecol 1996;175:1472-5.
  2. Milani R, Salvatore S, Soligo M, Pifarotti P, Meschia M, Cortese M. Functional and anatomical outcome of anterior and posterior vaginal prolapse repair with prolene mesh. Br J Obstet Gynaecol 2004;111:1-5.
  3. Barber MD et al. Psychometric evaluation of 2 comprehensive condition-specific quality of life instruments for women with pelvic floor disorders. Am J Obstet Gynecol 2001;185:1388-95.

Condition Intervention Phase
Vaginal Prolapse
Cystocele
Device: Ugytex
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Official Title: Comparison of the Prosthesis Ugytex by the Trans-Obturator Approach and Anterior Colporrhaphy for the Surgical Treatment of Anterior Vaginal Wall Prolapse.

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Rate of anatomical recurrence of anterior vaginal wall prolapse of stage 2 or more (POP-Q system) , at one year.

Secondary Outcome Measures:
  • Perioperative morbidity
  • Symptoms and quality of life questionnaires
  • Post-operative sexuality
  • Rate of local complications of prosthesis (vaginal erosion, prosthesis shrinkage)

Estimated Enrollment: 194
Study Start Date: June 2005
Estimated Study Completion Date: June 2011
  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients older than 60 years-old
  • Anterior vaginal wall prolapse of stage 2 or more (POP-Q system)
  • Symptomatic prolapse
  • Informed consent signature obtained

Exclusion Criteria:

  • Patient not able to read French language
  • Patient with a anterior prolapse of stage 1
  • Urinary of vaginal infection
  • Hepatopathy with ascitis
  • Diabetes uncontrolled
  • Treatment by corticosteroids
  • Previous pelvic irradiation
  • Intraoperative bladder injury
  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: NCT00153257

Contacts
Contact: Renaud de Tayrac, MD 0033603263232 renaud.detayrac@chu-nimes.fr

Locations
France
Hôpital Carémeau Recruiting
Nimes, France, 30000
Contact: Renaud de Tayrac, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
DRRC
Sofradim Corporation
Investigators
Study Director: Hervé Fernandez, MD Hôpital Béclère, Clamart, France
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00153257     History of Changes
Other Study ID Numbers: P040306, CRC04001
Study First Received: September 8, 2005
Last Updated: September 8, 2005
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
Cystocele
Prolapse
Uterine Prolapse
Urinary Bladder Diseases
Urologic Diseases
Pelvic Organ Prolapse
Pathological Conditions, Anatomical
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 24, 2014