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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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15 February 2016 |
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Main ID: |
NCT02255994 |
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Date of registration:
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01/10/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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UGYTEX® Mesh Versus Subvesical Plication in the Surgical Treatment of Bladder Prolapse
PRO-CURE II |
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Scientific title:
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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 |
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Date of first enrolment:
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October 2014 |
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Target sample size:
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75 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02255994 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Renaud de Tayrac, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre Hospitalier Universitaire de Nîmes |
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Key inclusion & exclusion criteria
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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
Age minimum:
60 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Cystocele
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Intervention(s)
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Device: UGYTEX
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Procedure: No mesh.
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Primary Outcome(s)
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Functional failure
[Time Frame: 5 years]
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Secondary Outcome(s)
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Post-operative complications
[Time Frame: 5-8 years]
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The PFDI questionnaire
[Time Frame: 5-8 years]
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Anatomical failure
[Time Frame: 5-8 years]
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The PISQ-12 questionnaire
[Time Frame: 5-8 years]
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The PFIQ questionnaire
[Time Frame: 5-8 years]
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The PGI-I questionnaire
[Time Frame: 5-8 years]
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Secondary ID(s)
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2013-A01705-40
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LOCAL/2013/RdeT-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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