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

Study Overview
=================
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 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

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 Bladder Prolapse

Conditions
-----------------
Cystocele

Intervention / Treatment
-----------------
* Device: UGYTEX
* Procedure: No mesh.


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UGYTEX<br>Patients in this arm received the UGYTEX mesh in the pro-cure 1 study (see NCT00153257) | Device: UGYTEX<br>* Patients in this arm received the UGYTEX mesh in the pro-cure 1 study (see NCT00153257)<br>|
| Active Comparator: No MESH<br>Patients in this arm had subvesical plication without reinforcement. | Procedure: No mesh.<br>* Patients in this arm had subvesical plication without reinforcement.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anatomical failure | 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. | 5-8 years | 
| Post-operative complications | 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. | 5-8 years | 
| The PGI-I questionnaire |  | 5-8 years | 
| The PFDI questionnaire |  | 5-8 years | 
| The PFIQ questionnaire |  | 5-8 years | 
| The PISQ-12 questionnaire |  | 5-8 years |