Urologic DiseasesNCT00662064
Pharmacology and Physiology of the Lower Urinary Tract
An observational study of Urologic Diseases, run by University College London Hospitals at 1 site in United Kingdom.
Trial summary
The function of the lower urinary tract is simple - urine storage and voiding. However, despite this simplicity of function, the control of the lower urinary tract is a rather complex, multilevel process (urothelium, detrusor, peripheral nerves, spinal cord and higher cerebral centres) and the mechanisms involved… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urologic Diseases
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2002to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with lower urinary tract dysfunction and controls with normal lower urinary tract function
Who may be able to join
- Patients with lower urinary tract dysfunction
- Controls with normal lower urinary tract function
Who cannot join
- Age < 18 years old
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Department of Uro-Neurology, The National Hospital for Neurology and Neurosurgery
London, WC1N 3BG
Thomas M Kessler, MD, 44-207-829-8713 ext. 8713, tkessler@gmx.ch
Shahid Khan, MD, 44-207-829-8713 ext. 8713, drshahidkhan@gmail.com
About this study
The function of the lower urinary tract is simple - urine storage and voiding. However, despite this simplicity of function, the control of the lower urinary tract is a rather complex, multilevel process (urothelium, detrusor, peripheral nerves, spinal cord and higher cerebral centres) and the mechanisms involved remain poorly elucidated.
This study is designed to gain a more in depth understanding of the lower urinary tract function. Using bladder biopsies, tissue staining for characteristic markers present on nerves and other cells will be performed. We hypothesize that certain markers are altered in disease and turn back towards the control level of healthy people or patients with successful medical treatment.
- Conditions
- Urologic Diseases
- Keywords
- Lower urinary tract, Physiology, Pathology, Immunohistochemistry, Urinary bladder
- Medical subject headings
- Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with lower urinary tract dysfunction | |
| 2 | Controls with normal lower urinary tract function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunohistochemistry + PCR of bladder tissue
Measured: not specified (storage of biopsies)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startFeb 2002
- Primary completionDec 2008 (estimated)
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urologic DiseasesStudies 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
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College London Hospitals
- Sponsor type
- University, hospital or other
- Investigators
- Clare J Fowler, FRCP, Principal investigator, Department of Uro-Neurology, National Hospital for Neurology and Neurosurgery, University College London Hospitals, London, UKSuzy Elneil, PhD, MRCOG, Principal investigator, Department of Uro-Neurology, National Hospital for Neurology and Neurosurgery, University College London Hospitals, London, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00662064
- Sponsor's protocol ID
- 00/0039
- Status last verified
- Jun 2008
- First submitted
- 16 Apr 2008
- Last updated
- 20 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Roosen A, Datta SN, Chowdhury RA, Patel PM, Kalsi V, Elneil S, Dasgupta P, Kessler TM, Khan S, Panicker J, Fry CH, Brandner S, Fowler CJ, Apostolidis A. Suburothelial myofibroblasts in the human overactive bladder and the effect of botulinum neurotoxin type A treatment. Eur Urol. 2009 Jun;55(6):1440-8. doi: 10.1016/j.eururo.2008.11.009. Epub 2008 Nov 18.
PubMed 19054608
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacology and Physiology of the Lower Urinary Tract
- ClinicalTrials.gov ID
- NCT00662064
- Acronym / sponsor ID
- 00/0039
- Conditions
- Urologic Diseases
- Keywords
- Lower urinary tract, Physiology, Pathology, Immunohistochemistry, Urinary bladder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University College London HospitalsUniversity, hospital or other
- Study start
- Feb 2002
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Dec 2008 (estimated)
- First posted
- 21 Apr 2008 (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.
The function of the lower urinary tract is simple - urine storage and voiding. However, despite this simplicity of function, the control of the lower urinary tract is a rather complex, multilevel process (urothelium, detrusor, peripheral nerves, spinal cord and higher cerebral centres) and the mechanisms involved remain poorly elucidated.
This study is designed to gain a more in depth understanding of the lower urinary tract function. Using bladder biopsies, tissue staining for characteristic markers present on nerves and other cells will be performed. We hypothesize that certain markers are altered in disease and turn back towards the control level of healthy people or patients with successful medical treatment.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with lower urinary tract dysfunction |
| 2 | – | –Controls with normal lower urinary tract function |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with lower urinary tract dysfunction and controls with normal lower urinary tract function
Key inclusion criteria (2 listed)
- Patients with lower urinary tract dysfunction
- Controls with normal lower urinary tract function
Key exclusion criteria (2 listed)
- Age < 18 years old
- Pregnancy
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
Immunohistochemistry + PCR of bladder tissue
Time frame: not specified (storage of biopsies)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2008.
- Derived from this study: PubMed 19054608Roosen A, Datta SN, Chowdhury RA, Patel PM, Kalsi V, Elneil S, Dasgupta P, Kessler TM, Khan S, Panicker J, Fry CH, Brandner S, Fowler CJ, Apostolidis A. Suburothelial myofibroblasts in the human overactive bladder and the effect of botulinum neurotoxin type A treatment. Eur Urol. 2009 Jun;55(6):1440-8. doi: 10.1016/j.eururo.2008.11.009. Epub 2008 Nov 18.
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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. This study is not recruiting at the moment.
Clare J Fowler, FRCP principal investigator
Department of Uro-Neurology, National Hospital for Neurology and Neurosurgery, University College London Hospitals, London, UK
Suzy Elneil, PhD, MRCOG principal investigator
Department of Uro-Neurology, National Hospital for Neurology and Neurosurgery, University College London Hospitals, London, UK
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 Urologic Diseases, run by University College London Hospitals at 1 site in United Kingdom.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 20 Jun 2008. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas M Kessler, MD (44-207-829-8713 ext. 8713, tkessler@gmx.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunohistochemistry + PCR of bladder tissue (time frame: not specified (storage of biopsies)). 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 NCT00662064, which also lists 1 linked publication.
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 20 Jun 2008.