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 IV

Further Study Details: 

Primary Outcomes: Rate of anatomical recurrence of anterior vaginal wall prolapse of stage 2 or more (POP-Q system) , at one year.
Secondary Outcomes: Perioperative morbidity; Symptoms and quality of life questionnaires; Post-operative sexuality; Rate of local complications of prosthesis (vaginal erosion, prosthesis shrinkage)
Expected Total Enrollment:  194

Ages Eligible for Study:  60 Years and above,  Genders Eligible for Study:  Female

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00153257

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

France
      Hôpital Carémeau, Nimes,  30000,  France; Recruiting

Study chairs or principal investigators

Hervé Fernandez, MD,  Study Director,  Hôpital Béclère, Clamart, France   

Study ID Numbers:  P040306; CRC04001
Last Updated:  September 9, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00153257
Health Authority: France: Ministry of Health
ClinicalTrials.gov processed this record on 2005-09-13