NCT02255994

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: Female
• Age: 60 Years
• Healthy volunteers: Not accepted

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

Conditions

• Cystocele

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-12-07
• Completion: 2015-12-07
• First posted: 2014-10-03
• Last updated: 2025-11-19

Locations

12 sites across 1 country: France