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

Urinary Incontinence Clinical Trial

Official title:

A Quantitative Analysis of Protein- and mRNA-Expression of Nitric Oxide Syntheses and Their Functional Role in Human Urothelium

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00253006
• Other study ID #: UA_H_Ka-05104-m
• Status: Terminated
• Phase: N/A
• First received: November 11, 2005
• Last updated: October 6, 2006
• Start date: January 2006
• Est. completion date: January 2008

Study information

• Verified date: October 2006
• Source: Copenhagen University Hospital at Herlev
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Defined Population, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Bladder Diseases
• Cystitis, Interstitial
• Interstitial Cystitis
• Urinary Bladder Diseases
• Urinary Incontinence

Intervention

Procedure:
• Tissue examination for protein- and mRNA-expression of NO

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital at Herlev	Herlev

Sponsors (2)

Lead Sponsor	Collaborator
Copenhagen University Hospital at Herlev	Roskilde County Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

Birder LA, Wolf-Johnston A, Buffington CA, Roppolo JR, de Groat WC, Kanai AJ. Altered inducible nitric oxide synthase expression and nitric oxide production in the bladder of cats with feline interstitial cystitis. J Urol. 2005 Feb;173(2):625-9. — View Citation

Bouchelouche K, Nordling J. Recent developments in the management of interstitial cystitis. Curr Opin Urol. 2003 Jul;13(4):309-13. Review. — View Citation

Logadottir YR, Ehren I, Fall M, Wiklund NP, Peeker R, Hanno PM. Intravesical nitric oxide production discriminates between classic and nonulcer interstitial cystitis. J Urol. 2004 Mar;171(3):1148-50; discussion 50-1. — View Citation