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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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30 May 2016 |
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Main ID: |
NCT01660438 |
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Date of registration:
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06/08/2012 |
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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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Urethral Length Measurement in Women Undergoing Suburethral Sling Operative Procedure
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Scientific title:
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Prospective, Non-randomized, Observational Study of the Surgical Management of Suburethral Slings in Women With Stress Urinary Incontinence |
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Date of first enrolment:
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August 2010 |
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Target sample size:
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188 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01660438 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Germany
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Poland
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Switzerland
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Contacts
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Name:
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Volker Viereck, Prof. 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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Cantonal Hospital, Frauenfeld |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Patient has objective, demonstrable signs of stress urinary incontinence (SUI),
including patients with intrinsic sphincter deficiency (ISD). Objective testing
includes: standing stress test, urodynamics evaluation or pad test.
2. Patient is age 18 or older.
3. Patient agrees to participate in the study, including completion of all study-related
procedures and evaluations, and documents this agreement by signing the Institutional
Review Board/Ethics Committee-approved informed consent form.
4. Patient is able to fill in all questionnaires (based on judgment of investigator)
Exclusion Criteria:
1. Patient has an associated or suspected neurological disease.
2. Patient has an active lesion or present injury to perineum or urethra.
3. Patient has a urethral obstruction.
4. Patient has significant pelvic organ prolapse (Grade III/IV) requiring surgical
treatment.
5. Patient has current urinary tract infection.
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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Stress Urinary Incontinence
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Primary Outcome(s)
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Cure rate
[Time Frame: 3 months]
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Secondary Outcome(s)
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Pad test
[Time Frame: Pre-operation and 3 months]
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Pelvic floor sonography
[Time Frame: Pre-operation, day 1 and 3 months]
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Urethral length measurement
[Time Frame: Intra-operation]
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Residual urine
[Time Frame: Pre-operation, day 1 and 3 months]
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Secondary ID(s)
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TVT 112010
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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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