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

Sponsor

Centre Hospitalier Universitaire de Nīmes (Other)

Overall Status

Completed

CT.gov ID

NCT02255994

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

6.3

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cystocele	Device: UGYTEX Procedure: No mesh.	N/A

Detailed Description

Secondary objectives include comparing the following elements between the two randomized groups at a long-term time point (5-8 years):

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 Design

Study Type:

Interventional

Actual Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Oct 1, 2014

Actual Primary Completion Date :

Oct 1, 2015

Actual Study Completion Date :

Oct 1, 2015

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: UGYTEX

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

Device: UGYTEX

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

Active Comparator: No MESH

Patients in this arm had subvesical plication without reinforcement.

Procedure: No mesh.

Patients in this arm had subvesical plication without reinforcement.

Outcome Measures

Primary Outcome Measures

Functional failure [5 years]
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.

Secondary Outcome Measures

Anatomical failure [5-8 years]
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.
Post-operative complications [5-8 years]
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.
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Clinique Champeau	Béziers	France	34500
2	APHP - Hôpital Antoine Beclere	Clamart Cedex	France	92141
3	CHU de Clermont Ferrand - Hôpital Estaing	Clermont Ferrand	France	63003
4	APHP - Hôpital Beaujon	Clichy	France	92110
5	CH d'Issoire - Centre Hospitalier Paul Ardier	Issoire	France	63503
6	CH de la Rochelle	La Rochelle Cedex	France	17019
7	CH de Chartres - Hôpital Louis Pasteur	Le Coudray	France	28630
8	APHP - Centre Hospitalier Universitaire de Bicêtre	Le Kremlin Bicêtre Cedex	France	94275
9	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09	France	30029
10	CH d'Orange - Hôpital Louis Giorgi	Orange	France	84106
11	Clinique Mutualiste La Sagesse	Rennes	France	35000
12	CHU de Rouen - Hôpital Charles Nicolle	Rouen	France	76031

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nīmes

Investigators

Study Director: Renaud de Tayrac, MD, PhD, Centre Hospitalier Universitaire de Nîmes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Nīmes

ClinicalTrials.gov Identifier:

NCT02255994

Other Study ID Numbers:

LOCAL/2013/RdeT-01
2013-A01705-40

First Posted:

Oct 3, 2014

Last Update Posted:

Feb 8, 2016

Last Verified:

Feb 1, 2016

Additional relevant MeSH terms:

Cystocele

Prolapse

Study Results

No Results Posted as of Feb 8, 2016