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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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6 May 2024 |
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Main ID: |
NCT02272309 |
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Date of registration:
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20/10/2014 |
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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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Neurophysiological Assessment of Healthy and Impaired Human Lower Urinary Tract Function
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Scientific title:
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Date of first enrolment:
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May 2014 |
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Target sample size:
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124 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02272309 |
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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: Single Group Assignment. Primary purpose: Basic Science. 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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Switzerland
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Key inclusion & exclusion criteria
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Inclusion Criteria:
healthy volunteers:
- Written informed consent,
- good mental and physical health,
- age >18y,
Patients with LUTS and Patients with LUTS and treatment:
- Written informed consent,
- age >18y,
- prior urodynamic investigation,
- LUTS since >6months with or without detrusor overactivity
Exclusion Criteria:
healthy volunteers:
- any neurological or urological pathology,
- current pregnancy or lactation,
- urinary tract infection,
- hematuria,
- any previous pelvic or spine or craniocerebral surgery,
- any anatomical anomaly of the LUT or genitalia,
- any metabolic disease,
- any LUT malignancy,
- bladder capacity <150mL,
- SDV at 60mL;
Patients with LUTS and Patients with LUTS and treatment:
- current pregnancy or lactation,
- urinary tract infection,
- gross hematuria
Age minimum:
18 Years
Age maximum:
99 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Lower Urinary Tract Symptoms
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Intervention(s)
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Procedure: EEG and EP measurement
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Primary Outcome(s)
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N1latency of LUT SEPs
[Time Frame: 2-3 measurements within 4-16 weeks from first exam]
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Secondary ID(s)
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KEK-ZH_2013-0518/PB_2016-00498
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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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