NCT02255994

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

12 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2015

Completed
Last Updated

November 19, 2025

Status Verified

February 1, 2016

Enrollment Period

1.2 years

First QC Date

October 1, 2014

Last Update Submit

November 17, 2025

Conditions

Cystocele

Outcome Measures

Primary Outcomes (1)

  • 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.

    5 years

Secondary Outcomes (6)

  • Anatomical failure

    5-8 years

  • Post-operative complications

    5-8 years

  • The PGI-I questionnaire

    5-8 years

  • The PFDI questionnaire

    5-8 years

  • The PFIQ questionnaire

    5-8 years

  • +1 more secondary outcomes

Study Arms (2)

UGYTEX

EXPERIMENTAL

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

Device: UGYTEX

No MESH

ACTIVE COMPARATOR

Patients in this arm had subvesical plication without reinforcement.

Procedure: No mesh.

Interventions

UGYTEXDEVICE

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

UGYTEX
No mesh.PROCEDURE

Patients in this arm had subvesical plication without reinforcement.

No MESH

Eligibility Criteria

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Clinique Champeau

Béziers, 34500, France

Location

APHP - Hôpital Antoine Beclere

Clamart, 92141, France

Location

CHU de Clermont Ferrand - Hôpital Estaing

Clermont-Ferrand, 63003, France

Location

APHP - Hôpital Beaujon

Clichy, 92110, France

Location

CH d'Issoire - Centre Hospitalier Paul Ardier

Issoire, 63503, France

Location

CH de la Rochelle

La Rochelle, 17019, France

Location

CH de Chartres - Hôpital Louis Pasteur

Le Coudray, 28630, France

Location

APHP - Centre Hospitalier Universitaire de Bicêtre

Le Kremlin-Bicêtre, 94275, France

Location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

CH d'Orange - Hôpital Louis Giorgi

Orange, 84106, France

Location

Clinique Mutualiste La Sagesse

Rennes, 35000, France

Location

CHU de Rouen - Hôpital Charles Nicolle

Rouen, 76031, France

Location

Related Publications (1)

  • Allegre L, Callewaert G, Alonso S, Cornille A, Fernandez H, Eglin G, de Tayrac R. Long-term outcomes of a randomized controlled trial comparing trans-obturator vaginal mesh with native tissue repair in the treatment of anterior vaginal wall prolapse. Int Urogynecol J. 2020 Apr;31(4):745-753. doi: 10.1007/s00192-019-04073-x. Epub 2019 Sep 10.

    PMID: 31506808RESULT

MeSH Terms

Conditions

Cystocele

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPelvic Organ ProlapseProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Renaud de Tayrac, MD, PhD

    Centre Hospitalier Universitaire de Nîmes

    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

October 1, 2014

First Posted

October 3, 2014

Study Start

October 1, 2014

Primary Completion

December 7, 2015

Study Completion

December 7, 2015

Last Updated

November 19, 2025

Record last verified: 2016-02

Locations

FR(12)