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Analysis of Expression of Nitric Oxide Syntheses and Their Functional Role in Human Urothelium

This study has been terminated.
Sponsor:
Collaborator:
Roskilde County Hospital
Information provided by:
Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier:
NCT00253006
First received: November 11, 2005
Last updated: October 6, 2006
Last verified: October 2006
History of Changes
  Purpose

Painful bladder syndrome (PBS)/interstitial cystitis (IC) may be due to the actions of nitric oxide (NO) in the bladder tissue. NO is a gaseous substance with a very short half-life, synthesized by a group of NO-synthase-enzymes in many tissues.

The goal of this study is to illuminate bladder tissue production of NO in individuals with PBS and healthy individuals, by quantification of NO and NO-enzyme expression by different molecular biological methods.


Condition Intervention
Interstitial Cystitis
Bladder Diseases
Urinary Incontinence
 Procedure: Tissue examination for protein- and mRNA-expression of NO

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Cross-Sectional
Time Perspective: Retrospective/Prospective
Official Title: A Quantitative Analysis of Protein- and mRNA-Expression of Nitric Oxide Syntheses and Their Functional Role in Human Urothelium

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Copenhagen University Hospital at Herlev:

Estimated Enrollment: 60
Study Start Date: January 2006
Estimated Study Completion Date: January 2008
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • PBS/IC according to International Continence Society (ICS)
  • Cystoscopy with bladder distension and deep biopsies within last 5 years
  • Cystometry within last 5 years
  • Normal urine culture within last month

Inclusion Criteria (for control group):

  • Benign non-invasive bladder disease
  • No PBS/IC
  • Normal urine culture
  • No functional bladder disease of known nature (ex. infravesical obstruction)

Exclusion Criteria:

  • Age under 18 years
  • Inability to understand instructions
  • Pregnancy and lactation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00253006

Locations
Denmark
Copenhagen University Hospital at Herlev
Herlev, Denmark, DK- 2730
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
Roskilde County Hospital
Investigators
Study Director: Pierre Bouchelouche, MD Roskilde County University Hospital at Koege, Dept. of Clinical Biochemistry
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00253006     History of Changes
Other Study ID Numbers: UA_H_Ka-05104-m
Study First Received: November 11, 2005
Last Updated: October 6, 2006
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Copenhagen University Hospital at Herlev:
NO
mRNA-expression
pathophysiology
painful bladder syndrome

Additional relevant MeSH terms:
Urinary Bladder Diseases
Cystitis
Urinary Incontinence
Cystitis, Interstitial
Urologic Diseases
Urination Disorders
Urological Manifestations
Signs and Symptoms
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents

ClinicalTrials.gov processed this record on May 23, 2013