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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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29 June 2015 |
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Main ID: |
NCT02469584 |
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Date of registration:
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05/06/2015 |
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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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Small Stitch Study
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Scientific title:
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Continuous Small Stitch Technique for Anterior Colporrhaphy: a Pilot Study |
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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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10 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02469584 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group 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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Austria
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Contacts
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Name:
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Ksenia Halpern, Dr |
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Address:
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Telephone:
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004314040029150 |
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Email:
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Affiliation:
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Name:
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Engelbert Hanzal, Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical University of Vienna |
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Name:
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Ksenia Halpern, Dr |
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Address:
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Telephone:
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00431404040029150 |
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Email:
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ksenia.halpern@meduniwien.ac.at |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- women older than 18 years of age
- Able to read, understand and sign informed consent
- symptomatic cystocele described as Points Aa or Ba >= 0 according to the
International Continence Society pelvic organ prolapse quantification system (POP-Q)
Exclusion Criteria:
- previous urogynecological operation
- gynecologic malignancy
- planned concomitant incontinence operation
- other contraindications for surgery
- pregnancy
- systemic glucocorticoid treatment
- contraindication for the surgery
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Anterior Vaginal Wall Prolapse
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Intervention(s)
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Procedure: small stitch anterior colporrhaphy
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Primary Outcome(s)
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the most distal point of the anterior vaginal wall- postoperative anterior vaginal support described as Point Ba (POP-Q score)
[Time Frame: 4-6 weeks, 3 months]
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Secondary ID(s)
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1236/2014
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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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