Cystocele, Vaginal Prolapse
Conditions
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.
Interventions
DEVICEUgytex
Anterior repair reinforced by a specially designed mesh: UgytexTM
Sponsors
DRRC
Medtronic - MITG
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
60 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of anatomical recurrences of anterior vaginal wall prolapse of stage 2 or more (POP-Q system) | 1 year | POP-Q score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative and postoperative morbidity | 3 years | Number of Major and minor complication |
| Functionnal results following intervention | 3 years | Symptoms and quality of life questionnaires |
| Rate of local complications of prosthesis (vaginal erosion, prosthesis shrinkage) | 3 years | — |
| Post-operative sexuality | 3 years | PISQ score |
Countries
France
Outcome results
None listed