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Pharmacology and Physiology of the Lower Urinary Tract

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2008 by University College London Hospitals.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00662064
First Posted: April 21, 2008
Last Update Posted: June 20, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University College London Hospitals
  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

Study Type: Observational
Study Design: Time Perspective: 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) ]

Biospecimen Retention:   Samples Without DNA
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof C J Fowler, Prof C H Fry, Dep Uro-Neurology, National Hospital for Neurology and Neurosurgery, London, UK
ClinicalTrials.gov Identifier: NCT00662064     History of Changes
Other Study ID Numbers: 00/0039
First Submitted: April 16, 2008
First Posted: April 21, 2008
Last Update Posted: June 20, 2008
Last Verified: June 2008

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

Additional relevant MeSH terms:
Urologic Diseases