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Pharmacology and Physiology of the Lower Urinary Tract
This study is currently recruiting participants.
Verified by University College London Hospitals, June 2008
First Received: April 16, 2008   Last Updated: June 19, 2008   History of Changes
Sponsored by: University College London Hospitals
Information provided by: University College London Hospitals
ClinicalTrials.gov Identifier: NCT00662064
  Purpose

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.


Condition
Urologic Diseases

U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: Pharmacology and Physiology of the Lower Urinary Tract

Further study details as provided by University College London Hospitals:

Primary Outcome Measures:
  • Immunohistochemistry + PCR of bladder tissue [ Time Frame: not specified (storage of biopsies) ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

bladder biopsies from patients with lower urinary tract dysfunction and from healthy controls


Estimated Enrollment: 200
Study Start Date: February 2002
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients with lower urinary tract dysfunction
2
Controls with normal lower urinary tract function

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with lower urinary tract dysfunction and controls with normal lower urinary tract function

Criteria

Inclusion Criteria:

  • Patients with lower urinary tract dysfunction
  • Controls with normal lower urinary tract function

Exclusion Criteria:

  • Age < 18 years old
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00662064

Contacts
Contact: Thomas M Kessler, MD 44-207-829-8713 ext 8713 tkessler@gmx.ch
Contact: Shahid Khan, MD 44-207-829-8713 ext 8713 drshahidkhan@gmail.com

Locations
United Kingdom
Department of Uro-Neurology, The National Hospital for Neurology and Neurosurgery Recruiting
London, United Kingdom, WC1N 3BG
Contact: Thomas M Kessler, MD     44-207-829-8713 ext 8713     tkessler@gmx.ch    
Contact: Shahid Khan, MD     44-207-829-8713 ext 8713     drshahidkhan@gmail.com    
Principal Investigator: Clare J Fowler, FRCP            
Sponsors and Collaborators
University College London Hospitals
Investigators
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
  More Information

No publications provided

Responsible Party: Dep Uro-Neurology, National Hospital for Neurology and Neurosurgery, London, UK ( Prof C J Fowler, Prof C H Fry )
Study ID Numbers: 00/0039
Study First Received: April 16, 2008
Last Updated: June 19, 2008
ClinicalTrials.gov Identifier: NCT00662064     History of Changes
Health Authority: United Kingdom: National Health Service

Keywords provided by University College London Hospitals:
Lower urinary tract
Physiology
Pathology
Immunohistochemistry
Urinary bladder

Study placed in the following topic categories:
Urologic Diseases

Additional relevant MeSH terms:
Urologic Diseases

ClinicalTrials.gov processed this record on May 07, 2009