Clinical trial NCT00153257: Comparative Study of Mesh Versus No Mesh in Prolapse Surgery
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginal Prolapse
Cystocele
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
Collaborators: name: DRRC
name: Medtronic - MITG
First posted: 2005-09-12
Enrollment: 162
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: number of anatomical recurrences of anterior vaginal wall prolapse of stage 2 or more (POP-Q system)
timeFrame: 1 year
Secondary outcomes:
measure: Perioperative and postoperative morbidity
timeFrame: 3 years
measure: Functionnal results following intervention
timeFrame: 3 years
measure: Rate of local complications of prosthesis (vaginal erosion, prosthesis shrinkage)
timeFrame: 3 years
measure: Post-operative sexuality
timeFrame: 3 years
Other outcomes:
Locations:
city: Nimes
country: France
facility: Hôpital Carémeau
Study officials:
affiliation: Hôpital Béclère, Clamart, France
name: Hervé Fernandez, MD
role: STUDY_DIRECTOR
References: