Comparative Study of Mesh Versus No Mesh in Prolapse Surgery

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: NCT00153257
Recruitment Status : Unknown
Verified September 2005 by Centre Hospitalier Universitaire de Nīmes.
Recruitment status was:  Recruiting
First Posted : September 12, 2005
Last Update Posted : September 12, 2005
Sofradim Corporation
Information provided by:
Centre Hospitalier Universitaire de Nīmes

Brief Summary:

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 or disease Intervention/treatment Phase
Vaginal Prolapse Cystocele Device: Ugytex Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 194 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : June 2005
Study Completion Date : June 2011

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

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): NCT00153257

Contact: Renaud de Tayrac, MD 0033603263232

Hôpital Carémeau Recruiting
Nimes, France, 30000
Contact: Renaud de Tayrac, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Sofradim Corporation
Study Director: Hervé Fernandez, MD Hôpital Béclère, Clamart, France Identifier: NCT00153257     History of Changes
Other Study ID Numbers: P040306
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: September 12, 2005
Last Verified: September 2005

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