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Effects of Ketamine on Human Bladders and Its Possible Mechanisms

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT00957333
First received: August 3, 2009
Last updated: November 18, 2010
Last verified: November 2010
History of Changes
  Purpose

This study is aimed to evaluate the relationship between ketamine abused and bladder dysfunction and its possible mechanisms.


Condition Intervention
Cystitis
 Other: ketamine

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Effects of Ketamine on Human Bladders and Its Possible Mechanisms

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Taipei Medical University WanFang Hospital:

Primary Outcome Measures:
  • Substance abuse situation record [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • urinary bladder capacity [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

1.Urine 2.Blood 3.Biopsy


Estimated Enrollment: 20
Study Start Date: March 2009
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
case
ketamine + Cystitis
 Other: ketamine
N.A.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

primary care clinic

Criteria

Inclusion Criteria:

  • Adult male or female
  • Cystitis (the clinicians ruled out the causes of bacterial infection)
  • Frequent micturition
  • The clinicians are willing to sign the ICF

Exclusion Criteria:

  • Suffers from the urinary system disease, is not suitable to carry on the urinary bladder biopsy sampling
  • Suffers from other diseases, doctor recognized that is not suitable to carry on the sampling
  • The clinicians are not willing to sign the ICF
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00957333

Locations
Taiwan
Taipei Medical University-Wan Fang Hospital
Taipei, Taiwan
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
Principal Investigator: Ruei-Ming Chen, PhD Taipei Medical University-Wan Fang Hospital
  More Information

No publications provided

Responsible Party: Ruei-Ming Chen, Professor, Taipei Medical University Graduate Institute of Medical Sciences
ClinicalTrials.gov Identifier: NCT00957333     History of Changes
Other Study ID Numbers: DOH98-NNB-1049
Study First Received: August 3, 2009
Last Updated: November 18, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Medical University WanFang Hospital:
ketamine
bladder dysfunction
bladder mucosa
mechanisms

Additional relevant MeSH terms:
Cystitis
Urinary Bladder Diseases
Urologic Diseases
Ketamine
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013