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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Bladde

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 Summary:

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


Sponsor: Centre Hospitalier Universitaire de Nīmes

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • 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.
  • The PGI-I questionnaire [ Time Frame: 5-8 years ]
  • The PFDI questionnaire [ Time Frame: 5-8 years ]
  • The PFIQ questionnaire [ Time Frame: 5-8 years ]
  • The PISQ-12 questionnaire [ Time Frame: 5-8 years ]


Original Secondary Outcome: Same as current

Information By: Centre Hospitalier Universitaire de Nīmes

Dates:
Date Received: October 1, 2014
Date Started: October 2014
Date Completion:
Last Updated: February 5, 2016
Last Verified: February 2016