NCT00662064

Brief Summary

The function of the lower urinary tract is simple - urine storage and voiding. However, despite this simplicity of function, the control of the lower urinary tract is a rather complex, multilevel process (urothelium, detrusor, peripheral nerves, spinal cord and higher cerebral centres) and the mechanisms involved remain poorly elucidated. This study is designed to gain a more in depth understanding of the lower urinary tract function. Using bladder biopsies, tissue staining for characteristic markers present on nerves and other cells will be performed. We hypothesize that certain markers are altered in disease and turn back towards the control level of healthy people or patients with successful medical treatment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

February 1, 2002

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

June 20, 2008

Status Verified

June 1, 2008

Enrollment Period

6.8 years

First QC Date

April 16, 2008

Last Update Submit

June 19, 2008

Conditions

Keywords

Lower urinary tractPhysiologyPathologyImmunohistochemistryUrinary bladder

Outcome Measures

Primary Outcomes (1)

  • Immunohistochemistry + PCR of bladder tissue

    not specified (storage of biopsies)

Study Arms (2)

1

Patients with lower urinary tract dysfunction

2

Controls with normal lower urinary tract function

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with lower urinary tract dysfunction and controls with normal lower urinary tract function

You may qualify if:

  • Patients with lower urinary tract dysfunction
  • Controls with normal lower urinary tract function

You may not qualify if:

  • Age \< 18 years old
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Uro-Neurology, The National Hospital for Neurology and Neurosurgery

London, WC1N 3BG, United Kingdom

RECRUITING

Related Publications (1)

  • Roosen A, Datta SN, Chowdhury RA, Patel PM, Kalsi V, Elneil S, Dasgupta P, Kessler TM, Khan S, Panicker J, Fry CH, Brandner S, Fowler CJ, Apostolidis A. Suburothelial myofibroblasts in the human overactive bladder and the effect of botulinum neurotoxin type A treatment. Eur Urol. 2009 Jun;55(6):1440-8. doi: 10.1016/j.eururo.2008.11.009. Epub 2008 Nov 18.

Biospecimen

Retention: SAMPLES WITHOUT DNA

bladder biopsies from patients with lower urinary tract dysfunction and from healthy controls

MeSH Terms

Conditions

Urologic Diseases

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Clare J Fowler, FRCP

    Department of Uro-Neurology, National Hospital for Neurology and Neurosurgery, University College London Hospitals, London, UK

    PRINCIPAL INVESTIGATOR
  • Suzy Elneil, PhD, MRCOG

    Department of Uro-Neurology, National Hospital for Neurology and Neurosurgery, University College London Hospitals, London, UK

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas M Kessler, MD

CONTACT

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 16, 2008

First Posted

April 21, 2008

Study Start

February 1, 2002

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

June 20, 2008

Record last verified: 2008-06

Locations