Comparative Study of Mesh Versus No Mesh in Prolapse Surgery
Primary Purpose
Vaginal Prolapse, Cystocele
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ugytex
Sponsored by
About this trial
This is an interventional treatment trial for Vaginal Prolapse
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
Sites / Locations
- Hôpital Carémeau
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
Ugytex
No device
Arm Description
Anterior repair reinforced by a specially designed mesh: UgytexTM
standard anterior colporrhaphy
Outcomes
Primary Outcome Measures
number of anatomical recurrences of anterior vaginal wall prolapse of stage 2 or more (POP-Q system)
POP-Q score
Secondary Outcome Measures
Perioperative and postoperative morbidity
Number of Major and minor complication
Functionnal results following intervention
Symptoms and quality of life questionnaires
Rate of local complications of prosthesis (vaginal erosion, prosthesis shrinkage)
Post-operative sexuality
PISQ score
Full Information
NCT ID
NCT00153257
First Posted
September 8, 2005
Last Updated
November 20, 2019
Sponsor
Centre Hospitalier Universitaire de Nīmes
Collaborators
DRRC, Medtronic - MITG
1. Study Identification
Unique Protocol Identification Number
NCT00153257
Brief Title
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
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
Collaborators
DRRC, Medtronic - MITG
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Prolapse, Cystocele
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
162 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ugytex
Arm Type
Other
Arm Description
Anterior repair reinforced by a specially designed mesh: UgytexTM
Arm Title
No device
Arm Type
No Intervention
Arm Description
standard anterior colporrhaphy
Intervention Type
Device
Intervention Name(s)
Ugytex
Intervention Description
Anterior repair reinforced by a specially designed mesh: UgytexTM
Primary Outcome Measure Information:
Title
number of anatomical recurrences of anterior vaginal wall prolapse of stage 2 or more (POP-Q system)
Description
POP-Q score
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Perioperative and postoperative morbidity
Description
Number of Major and minor complication
Time Frame
3 years
Title
Functionnal results following intervention
Description
Symptoms and quality of life questionnaires
Time Frame
3 years
Title
Rate of local complications of prosthesis (vaginal erosion, prosthesis shrinkage)
Time Frame
3 years
Title
Post-operative sexuality
Description
PISQ score
Time Frame
3 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hervé Fernandez, MD
Organizational Affiliation
Hôpital Béclère, Clamart, France
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Carémeau
City
Nimes
ZIP/Postal Code
30000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Comparative Study of Mesh Versus No Mesh in Prolapse Surgery
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