UGYTEX® Mesh Versus Subvesical Plication in the Surgical Treatment of Bladder Prolapse (PRO-CURE II)

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Cystocele

Treatments: Device: UGYTEX; Procedure: No mesh.

Study type: Interventional

Funder types: Other

Identifiers

NCT02255994

LOCAL/2013/RdeT-01

2013-A01705-40 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 75 patients

Sex: Female

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

UGYTEX

Experimental group

Description:

Patients in this arm received the UGYTEX mesh in the pro-cure 1 study (see NCT00153257)

Treatment:

Device: UGYTEX

No MESH

Active Comparator group

Description:

Patients in this arm had subvesical plication without reinforcement.

Treatment:

Procedure: No mesh.