Effects of Ketamine on Human Bladders and Its Possible Mechanisms

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT00957333
First received: August 3, 2009
Last updated: December 8, 2015
Last verified: November 2010
  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:


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 ]
    Substance abuse situation record: ketamine


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

Enrollment: 44
Study Start Date: March 2009
Study Completion Date: December 2011
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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier: NCT00957333     History of Changes
Other Study ID Numbers: DOH98-NNB-1049 
Study First Received: August 3, 2009
Results First Received: December 8, 2015
Last Updated: December 8, 2015
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
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 25, 2016