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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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12 December 2020 |
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Main ID: |
NCT00153257 |
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Date of registration:
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08/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Comparative Study of Mesh Versus No Mesh in Prolapse Surgery
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Scientific title:
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Comparison of the Prosthesis Ugytex by the Trans-obturator Approach and Anterior Colporrhaphy for the Surgical Treatment of Anterior Vaginal Wall Prolapse |
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Date of first enrolment:
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April 2005 |
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Target sample size:
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162 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00153257 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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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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Hervé Fernandez, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hôpital Béclère, Clamart, France |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients older than 60 years-old
- Anterior vaginal wall prolapse of stage 2 or more (POP-Q system)
- Symptomatic prolapse
- Informed consent signature obtained
Exclusion Criteria:
- Patient not able to read French language
- Patient with a anterior prolapse of stage 1
- Urinary of vaginal infection
- Hepatopathy with ascitis
- Diabetes uncontrolled
- Treatment by corticosteroids
- Previous pelvic irradiation
- Intraoperative bladder injury
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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Vaginal Prolapse
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Intervention(s)
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Device: Ugytex
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Primary Outcome(s)
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number of anatomical recurrences of anterior vaginal wall prolapse of stage 2 or more (POP-Q system)
[Time Frame: 1 year]
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Secondary Outcome(s)
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Perioperative and postoperative morbidity
[Time Frame: 3 years]
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Rate of local complications of prosthesis (vaginal erosion, prosthesis shrinkage)
[Time Frame: 3 years]
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Post-operative sexuality
[Time Frame: 3 years]
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Functionnal results following intervention
[Time Frame: 3 years]
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Secondary ID(s)
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CRC04001
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P040306
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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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