- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01293110
Lower Urinary Tract Dysfunction Database
June 19, 2019 updated by: Thomas Kessler, University of Zurich
Database of Patients With Lower Urinary Tract Dysfunction Treated at the University of Zürich
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.
Study Overview
Status
Recruiting
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.
Study Type
Observational
Enrollment (Anticipated)
7000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Thomas M Kessler, MD
- Phone Number: +41 44 386 39 07
- Email: thomas.kessler@balgrist.ch
Study Contact Backup
- Name: Jure Tornic
- Phone Number: +41 44 386 39 07
- Email: jure.tornic@balgrist.ch
Study Locations
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-
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Zürich, Switzerland, 8008
- Recruiting
- Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital
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Contact:
- Thomas M Kessler, MD
- Phone Number: +41 44 386 39 07
- Email: thomas.kessler@balgrist.ch
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Ages Eligibility: minimum 18 years Genders Eligibility: female and male
Description
Inclusion Criteria:
- patient of Balgrist University Hospital
- patient of University Hospital Zürich
- urodynamic examination
- written informed consent
Exclusion Criteria:
- no written informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Survival of the patients
Time Frame: first visit to death
|
first visit to death
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thomas M Kessler, Universitätsklinik Balgrist
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Walter M, Knupfer SC, Cragg JJ, Leitner L, Schneider MP, Mehnert U, Krassioukov AV, Schubert M, Curt A, Kessler TM. Prediction of autonomic dysreflexia during urodynamics: a prospective cohort study. BMC Med. 2018 Apr 13;16(1):53. doi: 10.1186/s12916-018-1040-8.
- Leitner L, Guggenbuhl-Roy S, Knupfer SC, Walter M, Schneider MP, Tornic J, Sammer U, Mehnert U, Kessler TM. More Than 15 Years of Experience with Intradetrusor OnabotulinumtoxinA Injections for Treating Refractory Neurogenic Detrusor Overactivity: Lessons to Be Learned. Eur Urol. 2016 Sep;70(3):522-8. doi: 10.1016/j.eururo.2016.03.052. Epub 2016 Apr 19.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Anticipated)
January 1, 2030
Study Completion (Anticipated)
January 1, 2030
Study Registration Dates
First Submitted
February 9, 2011
First Submitted That Met QC Criteria
February 9, 2011
First Posted (Estimate)
February 10, 2011
Study Record Updates
Last Update Posted (Actual)
June 21, 2019
Last Update Submitted That Met QC Criteria
June 19, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KEK-2010-0207/0/PB_2016-0189
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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