Lower Urinary Tract Dysfunction Database
| Tracking Information | |||||||||
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| First Received Date ICMJE | February 9, 2011 | ||||||||
| Last Updated Date | January 8, 2013 | ||||||||
| Start Date ICMJE | January 2010 | ||||||||
| Estimated Primary Completion Date | January 2016 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT01293110 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Lower Urinary Tract Dysfunction Database | ||||||||
| Official Title ICMJE | Database of Patients With Lower Urinary Tract Dysfunction Treated at the University of Zürich | ||||||||
| Brief Summary | Patients with neurological disease/injury often suffer from lower urinary tract symptoms, which frequently have a negative impact on the patients' health related quality of life. The prevalence of lower urinary tract dysfunction is high and the treatment is a challenge because available treatments may fail. In this study data of patients with lower urinary tract dysfunction treated at the University of Zürich, are prospectively and systematically collected in a database. |
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| Detailed Description | Lower urinary tract dysfunction is characterized by detrusor overactivity, detrusor sphincter dyssynergia, voiding dysfunction, stress incontinence, or a combination of these and frequently has a negative impact on the patients' health related quality of life. In addition, the treatment of lower urinary tract dysfunction is a challenge because conventional therapies may fail. Adequate treatment and long-term follow-up of lower urinary tract dysfunction is important to achieve/maintain continence and preserve renal function. Thus, we aim to prospectively collect clinical, video-urodynamic and radiological data of patients with neurogenic lower urinary tract dysfunction treated at the University of Zürich in a database. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Ages Eligibility: minimum 18 years Genders Eligibility: female and male |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 3000 | ||||||||
| Estimated Completion Date | January 2016 | ||||||||
| Estimated Primary Completion Date | January 2016 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 90 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Switzerland | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01293110 | ||||||||
| Other Study ID Numbers ICMJE | EK 2010-0207/0 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Thomas M Kessler, Balgrist University Hospital | ||||||||
| Study Sponsor ICMJE | Balgrist University Hospital | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | Balgrist University Hospital | ||||||||
| Verification Date | January 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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