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

NCT02255994 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-11-19

No results posted yet for this study

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.

Conditions

  • Cystocele

Interventions

DEVICE

UGYTEX

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

PROCEDURE

No mesh.

Patients in this arm had subvesical plication without reinforcement.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nīmes

    lead OTHER

Principal Investigators

  • Renaud de Tayrac, MD, PhD · Centre Hospitalier Universitaire de Nîmes

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-12-07
Completion
2015-12-07

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02255994 on ClinicalTrials.gov