Neurogenic BladderNCT01293110
Lower Urinary Tract Dysfunction Database
An observational study of Neurogenic Bladder and Diseases of the Lower Urinary Tract: General Conditions, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurogenic Bladder, Diseases of the Lower Urinary Tract: General Conditions
- How many people
- 7,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2010to Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Ages Eligibility: minimum 18 years Genders Eligibility: female and male
Who may be able to join
- patient of Balgrist University Hospital
- patient of University Hospital Zürich
- urodynamic examination
- written informed consent
Who cannot join
- no written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital
Zurich, Canton of Zurich, 8008
Thomas M Kessler, MD, +41 44 386 39 07, thomas.kessler@balgrist.ch
About this study
Official title: 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.
Read the 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.
- Keywords
- urodynamics, neurogenic lower urinary tract dysfunction, neurological disease/injury
- Medical subject headings
- Urinary Bladder, Neurogenic, Nervous System Diseases, Wounds and Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival of the patients
Measured: first visit to death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2011 (estimated)
- Study startJan 2010
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neurogenic BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 7,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Kessler, Balgrist University Hospital
- Investigators
- Thomas M Kessler, Principal investigator, Universitätsklinik Balgrist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01293110
- Sponsor's protocol ID
- KEK-2010-0207/0/PB_2016-0189
- Status last verified
- Nov 2024
- First submitted
- 9 Feb 2011
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 29650001Leitner 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.
PubMed 27106070
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Database of Patients With Lower Urinary Tract Dysfunction Treated at the University of Zürich
- ClinicalTrials.gov ID
- NCT01293110
- Acronym / sponsor ID
- KEK-2010-0207/0/PB_2016-0189
- Keywords
- urodynamics, neurogenic lower urinary tract dysfunction, neurological disease/injury
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 10 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Ages Eligibility: minimum 18 years Genders Eligibility: female and male
Key inclusion criteria (4 listed)
- patient of Balgrist University Hospital
- patient of University Hospital Zürich
- urodynamic examination
- written informed consent
Key exclusion criteria (1 listed)
- no written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival of the patients
Time frame: first visit to death
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Derived from this study: PubMed 29650001Walter 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.
- Derived from this study: PubMed 27106070Leitner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas M Kessler principal investigator
Universitätsklinik Balgrist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurogenic Bladder and Diseases of the Lower Urinary Tract: General Conditions, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas M Kessler, MD (+41 44 386 39 07, thomas.kessler@balgrist.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival of the patients (time frame: first visit to death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01293110, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.