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

Centre Hospitalier Universitaire de Nīmes75 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cystocele

Interventions

UGYTEXDEVICE

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.

Eligibility

Sex: FEMALEMin age: 60 Years

Medical Language ↔ Plain English

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

Locations (12)

Clinique Champeau

Béziers, France

APHP - Hôpital Antoine Beclere

Clamart, France

CHU de Clermont Ferrand - Hôpital Estaing

Clermont-Ferrand, France

Outcomes

Primary Outcomes

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.

Time frame: 5 years

Secondary Outcomes

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.

Time frame: 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.

Time frame: 5-8 years

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

Data from ClinicalTrials.gov

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