Comparative Study of Mesh Versus No Mesh in Prolapse Surgery

Cystocele Clinical Trial

Official title:

Comparison of the Prosthesis Ugytex by the Trans-obturator Approach and Anterior Colporrhaphy for the Surgical Treatment of Anterior Vaginal Wall Prolapse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00153257
• Other study ID #: P040306
• Secondary ID: CRC04001
• Status: Completed
• Phase: N/A
• Start date: April 2005
• Est. completion date: January 2013

Study information

• Verified date: October 2019
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: January 2013
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystocele
• Prolapse
• Uterine Prolapse
• Vaginal Prolapse

Intervention

Device:
• Ugytex
Anterior repair reinforced by a specially designed mesh: UgytexTM

Locations

Country	Name	City	State
France	Hôpital Carémeau	Nimes

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes	DRRC, Medtronic - MITG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of anatomical recurrences of anterior vaginal wall prolapse of stage 2 or more (POP-Q system)	POP-Q score	1 year
Secondary	Perioperative and postoperative morbidity	Number of Major and minor complication	3 years
Secondary	Functionnal results following intervention	Symptoms and quality of life questionnaires	3 years
Secondary	Rate of local complications of prosthesis (vaginal erosion, prosthesis shrinkage)		3 years
Secondary	Post-operative sexuality	PISQ score	3 years