Comparative Study of Mesh Versus No Mesh in Prolapse Surgery

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Cystocele; Vaginal Prolapse

Treatments: Device: Ugytex

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00153257

CRC04001

P040306

Details and patient eligibility

About

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.

Enrollment: 162 patients

Sex: Female

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

162 participants in 2 patient groups

Ugytex

Other group

Description:

Anterior repair reinforced by a specially designed mesh: UgytexTM

Treatment:

Device: Ugytex

No device

No Intervention group

Description:

standard anterior colporrhaphy