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UGYTEX® Mesh Versus Subvesical Plication in the Surgical Treatment of Bladder Prolapse (PRO-CURE II)

Primary Purpose

Cystocele

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
UGYTEX
No mesh.
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystocele

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • The patient must have given her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • Patient included in, randomized and analysed in the PROCURE study (NCT00153257)

Exclusion Criteria:

  • The patient is under judicial protection, under tutorship or curatorship
  • The patient refuses to sign the consent
  • It is impossible to correctly inform the patient
  • Patient not included in the PROCURE study

Sites / Locations

  • Clinique Champeau
  • APHP - Hôpital Antoine Beclere
  • CHU de Clermont Ferrand - Hôpital Estaing
  • APHP - Hôpital Beaujon
  • CH d'Issoire - Centre Hospitalier Paul Ardier
  • CH de la Rochelle
  • CH de Chartres - Hôpital Louis Pasteur
  • APHP - Centre Hospitalier Universitaire de Bicêtre
  • CHRU de Nîmes - Hôpital Universitaire Carémeau
  • CH d'Orange - Hôpital Louis Giorgi
  • Clinique Mutualiste La Sagesse
  • CHU de Rouen - Hôpital Charles Nicolle

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

UGYTEX

No MESH

Arm Description

Patients in this arm received the UGYTEX mesh in the pro-cure 1 study (see NCT00153257)

Patients in this arm had subvesical plication without reinforcement.

Outcomes

Primary Outcome Measures

Functional failure
The primary efficacy endpoint of this study, is the functional failure at 5 years, defined using the functional response at 12 months in NCT00153257, the concept of surgery for prolapse and the answer to question No. 5 of the PFDI questionnaire submitted between 5 and 8 years postoperatively.

Secondary Outcome Measures

Anatomical failure
The anatomical failure is defined by a failure or recurrence at 12 months (data from NCT00153257), or surgery for prolapse or anatomic recurrence (recurrence of cystocele stage 2 or higher) upon examination at 5 to 8 years.
Post-operative complications
Major complications include surgery for prolapse repair, re-hospitalization or functional complications. Minor complications include all adverse events that are not major complications. Mesh-specific complications include vaginal pain, vaginal erosions, displacement and retraction of the mesh.
The PGI-I questionnaire
The PFDI questionnaire
The PFIQ questionnaire
The PISQ-12 questionnaire

Full Information

First Posted
October 1, 2014
Last Updated
February 5, 2016
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT02255994
Brief Title
UGYTEX® Mesh Versus Subvesical Plication in the Surgical Treatment of Bladder Prolapse
Acronym
PRO-CURE II
Official Title
Comparison of Long-term Results of UGYTEX® Sub-bladder Mesh Placed Via a Transvaginal Transobturator Approach Versus Subvesical Plication Without Reinforcement in the Surgical Treatment of Bladder Prolapse
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The main purpose of this study is to evaluate the long-term (5-8 years) functional prolapse recurrence rate of the 147 patients enrolled, randomized and analyzed in the study PRO-CURE I.
Detailed Description
Secondary objectives include comparing the following elements between the two randomized groups at a long-term time point (5-8 years): A. The anatomic failure rate of cystocele (POP-Q stage > or = 2) B. Late postoperative morbidity C. Residual post-operative pain (visual analog scale (VAS)) D. Patient satisfaction via the PGI-I questionnaire E. Quality of life via the PFDI and PFIQ questionnaires F. Sexual activity via the PISQ-12 questionnaire G. The rate of vaginal erosion H. Displacement and secondary shrinkage of meshs

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystocele

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
UGYTEX
Arm Type
Experimental
Arm Description
Patients in this arm received the UGYTEX mesh in the pro-cure 1 study (see NCT00153257)
Arm Title
No MESH
Arm Type
Active Comparator
Arm Description
Patients in this arm had subvesical plication without reinforcement.
Intervention Type
Device
Intervention Name(s)
UGYTEX
Intervention Description
Patients in this arm received the UGYTEX mesh in the pro-cure 1 study (see NCT00153257)
Intervention Type
Procedure
Intervention Name(s)
No mesh.
Intervention Description
Patients in this arm had subvesical plication without reinforcement.
Primary Outcome Measure Information:
Title
Functional failure
Description
The primary efficacy endpoint of this study, is the functional failure at 5 years, defined using the functional response at 12 months in NCT00153257, the concept of surgery for prolapse and the answer to question No. 5 of the PFDI questionnaire submitted between 5 and 8 years postoperatively.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Anatomical failure
Description
The anatomical failure is defined by a failure or recurrence at 12 months (data from NCT00153257), or surgery for prolapse or anatomic recurrence (recurrence of cystocele stage 2 or higher) upon examination at 5 to 8 years.
Time Frame
5-8 years
Title
Post-operative complications
Description
Major complications include surgery for prolapse repair, re-hospitalization or functional complications. Minor complications include all adverse events that are not major complications. Mesh-specific complications include vaginal pain, vaginal erosions, displacement and retraction of the mesh.
Time Frame
5-8 years
Title
The PGI-I questionnaire
Time Frame
5-8 years
Title
The PFDI questionnaire
Time Frame
5-8 years
Title
The PFIQ questionnaire
Time Frame
5-8 years
Title
The PISQ-12 questionnaire
Time Frame
5-8 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patient must have given her informed and signed consent The patient must be insured or beneficiary of a health insurance plan Patient included in, randomized and analysed in the PROCURE study (NCT00153257) Exclusion Criteria: The patient is under judicial protection, under tutorship or curatorship The patient refuses to sign the consent It is impossible to correctly inform the patient Patient not included in the PROCURE study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renaud de Tayrac, MD, PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Study Director
Facility Information:
Facility Name
Clinique Champeau
City
Béziers
ZIP/Postal Code
34500
Country
France
Facility Name
APHP - Hôpital Antoine Beclere
City
Clamart Cedex
ZIP/Postal Code
92141
Country
France
Facility Name
CHU de Clermont Ferrand - Hôpital Estaing
City
Clermont Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
APHP - Hôpital Beaujon
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
CH d'Issoire - Centre Hospitalier Paul Ardier
City
Issoire
ZIP/Postal Code
63503
Country
France
Facility Name
CH de la Rochelle
City
La Rochelle Cedex
ZIP/Postal Code
17019
Country
France
Facility Name
CH de Chartres - Hôpital Louis Pasteur
City
Le Coudray
ZIP/Postal Code
28630
Country
France
Facility Name
APHP - Centre Hospitalier Universitaire de Bicêtre
City
Le Kremlin Bicêtre Cedex
ZIP/Postal Code
94275
Country
France
Facility Name
CHRU de Nîmes - Hôpital Universitaire Carémeau
City
Nîmes Cedex 09
ZIP/Postal Code
30029
Country
France
Facility Name
CH d'Orange - Hôpital Louis Giorgi
City
Orange
ZIP/Postal Code
84106
Country
France
Facility Name
Clinique Mutualiste La Sagesse
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
CHU de Rouen - Hôpital Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France

12. IPD Sharing Statement

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UGYTEX® Mesh Versus Subvesical Plication in the Surgical Treatment of Bladder Prolapse

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