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

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ClinicalTrials.gov Identifier: NCT00253006
Recruitment Status : Terminated
First Posted : November 15, 2005
Last Update Posted : October 9, 2006
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:

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 or disease Intervention/treatment
Interstitial Cystitis Bladder Diseases Urinary Incontinence Procedure: Tissue examination for protein- and mRNA-expression of NO

Study Design

Study Type : Observational
Estimated Enrollment : 60 participants
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
Study Start Date : January 2006
Estimated Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

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:   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

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): NCT00253006


Locations
Denmark
Copenhagen University Hospital at Herlev
Herlev, Denmark, DK- 2730
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
Zealand University 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
First Posted: November 15, 2005    Key Record Dates
Last Update Posted: October 9, 2006
Last Verified: October 2006

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

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