NCT00153257

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

November 21, 2019

Status Verified

October 1, 2019

Enrollment Period

5.7 years

First QC Date

September 8, 2005

Last Update Submit

November 20, 2019

Conditions

Vaginal ProlapseCystocele

Outcome Measures

Primary Outcomes (1)

  • number of anatomical recurrences of anterior vaginal wall prolapse of stage 2 or more (POP-Q system)

    POP-Q score

    1 year

Secondary Outcomes (4)

  • Perioperative and postoperative morbidity

    3 years

  • Functionnal results following intervention

    3 years

  • Rate of local complications of prosthesis (vaginal erosion, prosthesis shrinkage)

    3 years

  • Post-operative sexuality

    3 years

Study Arms (2)

Ugytex

OTHER

Anterior repair reinforced by a specially designed mesh: UgytexTM

Device: Ugytex

No device

NO INTERVENTION

standard anterior colporrhaphy

Interventions

UgytexDEVICE

Anterior repair reinforced by a specially designed mesh: UgytexTM

Ugytex

Eligibility Criteria

Age60 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients older than 60 years-old
  • Anterior vaginal wall prolapse of stage 2 or more (POP-Q system)
  • Symptomatic prolapse
  • Informed consent signature obtained

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Carémeau

Nîmes, 30000, France

Location

MeSH Terms

Conditions

Uterine ProlapseCystocele

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPelvic Organ ProlapseProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Hervé Fernandez, MD

    Hôpital Béclère, Clamart, France

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

April 1, 2005

Primary Completion

December 1, 2010

Study Completion

January 1, 2013

Last Updated

November 21, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)