NCT00253006

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 15, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

October 9, 2006

Status Verified

October 1, 2006

First QC Date

November 11, 2005

Last Update Submit

October 6, 2006

Conditions

Keywords

NOmRNA-expressionpathophysiologypainful bladder syndrome

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Age under 18 years
  • Inability to understand instructions
  • Pregnancy and lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen University Hospital at Herlev

Herlev, DK- 2730, Denmark

Location

Related 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. doi: 10.1097/01.ju.0000145900.22849.1d.

    PMID: 15643277BACKGROUND
  • Bouchelouche K, Nordling J. Recent developments in the management of interstitial cystitis. Curr Opin Urol. 2003 Jul;13(4):309-13. doi: 10.1097/00042307-200307000-00007.

    PMID: 12811295BACKGROUND
  • 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. doi: 10.1097/01.ju.0000110501.96416.40.

    PMID: 14767289BACKGROUND

MeSH Terms

Conditions

Cystitis, InterstitialUrinary Bladder DiseasesUrinary Incontinence

Interventions

Proteins

Condition Hierarchy (Ancestors)

CystitisUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrination DisordersLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

  • Pierre Bouchelouche, MD

    Roskilde County University Hospital at Koege, Dept. of Clinical Biochemistry

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 11, 2005

First Posted

November 15, 2005

Study Start

January 1, 2006

Study Completion

January 1, 2008

Last Updated

October 9, 2006

Record last verified: 2006-10

Locations