Skip to main content
OpenTrials
Completed

NCT Number: NCT02255994

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cystocele Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Age range

60 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Champeau, Béziers, France

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ugytex

Device

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

No mesh.

Procedure

Patients in this arm had subvesical plication without reinforcement.

Primary outcomes

  1. Functional failure

    Time frame: 5 years

    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 outcomes

  1. Anatomical failure

    Time frame: 5-8 years

    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.

  2. Post-operative complications

    Time frame: 5-8 years

    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.

  3. The PGI-I questionnaire

    Time frame: 5-8 years

  4. The PFDI questionnaire

    Time frame: 5-8 years

  5. The PFIQ questionnaire

    Time frame: 5-8 years

  6. The PISQ-12 questionnaire

    Time frame: 5-8 years

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study 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

Acronym: PRO-CURE II

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 3, 2014
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.