Clinical trial NCT02255994: UGYTEX® Mesh Versus Subvesical Plication in the Surgical Treatment of Bladder Prolapse
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystocele
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2014-10-03
Enrollment: 75
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Functional failure
timeFrame: 5 years
Secondary outcomes:
measure: Anatomical failure
timeFrame: 5-8 years
measure: Post-operative complications
timeFrame: 5-8 years
measure: The PGI-I questionnaire
timeFrame: 5-8 years
measure: The PFDI questionnaire
timeFrame: 5-8 years
measure: The PFIQ questionnaire
timeFrame: 5-8 years
measure: The PISQ-12 questionnaire
timeFrame: 5-8 years
Other outcomes:
Locations:
city: Béziers
country: France
facility: Clinique Champeau
city: Clamart Cedex
country: France
facility: APHP - Hôpital Antoine Beclere
city: Clermont Ferrand
country: France
facility: CHU de Clermont Ferrand - Hôpital Estaing
city: Clichy
country: France
facility: APHP - Hôpital Beaujon
city: Issoire
country: France
facility: CH d'Issoire - Centre Hospitalier Paul Ardier
city: La Rochelle Cedex
country: France
facility: CH de la Rochelle
city: Le Coudray
country: France
facility: CH de Chartres - Hôpital Louis Pasteur
city: Le Kremlin Bicêtre Cedex
country: France
facility: APHP - Centre Hospitalier Universitaire de Bicêtre
city: Nîmes Cedex 09
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
city: Orange
country: France
facility: CH d'Orange - Hôpital Louis Giorgi
city: Rennes
country: France
facility: Clinique Mutualiste La Sagesse
city: Rouen
country: France
facility: CHU de Rouen - Hôpital Charles Nicolle
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Renaud de Tayrac, MD, PhD
role: STUDY_DIRECTOR
References: