Analysis of Expression of Nitric Oxide Syntheses and Thei... | NCT00253006

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

NCT00253006

Sponsor

Copenhagen University Hospital at Herlev

Status

Terminated

Last Update Posted

Oct 9, 2006Estimated

Enrollment

Phase

Not provided

Conditions

Interstitial Cystitis
Bladder Diseases
Urinary Incontinence

Interventions

Tissue examination for protein- and mRNA-expression of NO

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2006

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Not provided

Completion Date

Jan 2008

First Submitted Date

Nov 11, 2005

First Submission Date that Met QC Criteria

Nov 11, 2005

First Posted Date

Nov 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 6, 2006

Last Update Posted Date

Oct 9, 2006Estimated

Name	Class
Zealand University Hospital	OTHER

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Tissue examination for protein- and mRNA-expression of NO	Procedure

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pierre Bouchelouche, MD	Roskilde County University Hospital at Koege, Dept. of Clinical Biochemistry	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Copenhagen University Hospital at Herlev		Herlev		DK- 2730	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15643277	Background	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. doi: 10.1097/01.ju.0000145900.22849.1d.
12811295	Background

ID	Term
D018856	Cystitis, Interstitial
D001745	Urinary Bladder Diseases
D014549	Urinary Incontinence

ID	Term
D003556	Cystitis
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications