Pharmacology and Physiology of the Lower Urinary Tract
1 other identifier
observational
200
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2002
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2002
CompletedFirst Submitted
Initial submission to the registry
April 16, 2008
CompletedFirst Posted
Study publicly available on registry
April 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedJune 20, 2008
June 1, 2008
6.8 years
April 16, 2008
June 19, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Immunohistochemistry + PCR of bladder tissue
not specified (storage of biopsies)
Study Arms (2)
1
Patients with lower urinary tract dysfunction
2
Controls with normal lower urinary tract function
Eligibility Criteria
Patients with lower urinary tract dysfunction and controls with normal lower urinary tract function
You may qualify if:
- Patients with lower urinary tract dysfunction
- Controls with normal lower urinary tract function
You may not qualify if:
- Age \< 18 years old
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Uro-Neurology, The National Hospital for Neurology and Neurosurgery
London, WC1N 3BG, United Kingdom
Related Publications (1)
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.
PMID: 19054608DERIVED
Biospecimen
bladder biopsies from patients with lower urinary tract dysfunction and from healthy controls
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Clare J Fowler, FRCP
Department of Uro-Neurology, National Hospital for Neurology and Neurosurgery, University College London Hospitals, London, UK
- PRINCIPAL INVESTIGATOR
Suzy Elneil, PhD, MRCOG
Department of Uro-Neurology, National Hospital for Neurology and Neurosurgery, University College London Hospitals, London, UK
Central Study Contacts
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 16, 2008
First Posted
April 21, 2008
Study Start
February 1, 2002
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
June 20, 2008
Record last verified: 2008-06