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

Cystocele Clinical Trial

— PRO-CURE II  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02255994
• Other study ID #: LOCAL/2013/RdeT-01
• Secondary ID: 2013-A01705-40
• Status: Completed
• Phase: N/A
• First received: October 1, 2014
• Last updated: February 5, 2016
• Start date: October 2014
• Est. completion date: October 2015

Study information

• Verified date: February 2016
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystocele

Intervention

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.

Locations

Country	Name	City	State
France	Clinique Champeau	Béziers
France	APHP - Hôpital Antoine Beclere	Clamart Cedex
France	CHU de Clermont Ferrand - Hôpital Estaing	Clermont Ferrand
France	APHP - Hôpital Beaujon	Clichy
France	CH d'Issoire - Centre Hospitalier Paul Ardier	Issoire
France	CH de la Rochelle	La Rochelle Cedex
France	CH de Chartres - Hôpital Louis Pasteur	Le Coudray
France	APHP - Centre Hospitalier Universitaire de Bicêtre	Le Kremlin Bicêtre Cedex
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09
France	CH d'Orange - Hôpital Louis Giorgi	Orange
France	Clinique Mutualiste La Sagesse	Rennes
France	CHU de Rouen - Hôpital Charles Nicolle	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	The PGI-I questionnaire		5-8 years	No
Secondary	The PFDI questionnaire		5-8 years	No
Secondary	The PFIQ questionnaire		5-8 years	No
Secondary	The PISQ-12 questionnaire		5-8 years	No