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

• Sponsor: Copenhagen University Hospital at Herlev (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00253006
• Collaborator: Zealand University Hospital (Other)
• Enrollment: 60
• Location: 1
• Duration (Months): 24
• Patients Per Site Per Month: 2.5

Study Details

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

Study Design

• Study Type: Observational
• Observational Model: Defined Population
• Time Perspective: Other
• Official Title: A Quantitative Analysis of Protein- and mRNA-Expression of Nitric Oxide Syntheses and Their Functional Role in Human Urothelium
• Study Start Date: Jan 1, 2006
• Study Completion Date: Jan 1, 2008

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

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

• ClinicalTrials.gov Identifier: NCT00253006
• Other Study ID Numbers: UA_H_Ka-05104-m
• First Posted: Nov 15, 2005
• Last Update Posted: Oct 9, 2006
• Last Verified: Oct 1, 2006

• Keywords provided by , ,: NO; mRNA-expression; pathophysiology; painful bladder syndrome
• Additional relevant MeSH terms: Urinary Incontinence; Cystitis; Cystitis, Interstitial; Urinary Bladder Diseases

Study Results

No Results Posted as of Oct 9, 2006