Effects of Ketamine on Human Bladders and Its Possible Mechanisms

• Sponsor: Taipei Medical University WanFang Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00957333
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Duration (Months): 33
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cystitis	Other: ketamine

Study Design

• Study Type: Observational
• Actual Enrollment: 44 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: Effects of Ketamine on Human Bladders and Its Possible Mechanisms
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
case ketamine + Cystitis	Other: ketamine

Outcome Measures

Primary Outcome Measures

1. Substance Abuse Situation Record [1 day]

   Substance abuse situation record: ketamine

Secondary Outcome Measures

1. Urinary Bladder Capacity [1 day]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Taipei Medical University WanFang Hospital
• ClinicalTrials.gov Identifier: NCT00957333
• Other Study ID Numbers: DOH98-NNB-1049
• First Posted: Aug 12, 2009
• Last Update Posted: Jan 14, 2016
• Last Verified: Nov 1, 2010

• Keywords provided by Taipei Medical University WanFang Hospital: ketamine; bladder dysfunction; bladder mucosa; mechanisms
• Additional relevant MeSH terms: Cystitis; Ketamine

Study Results

Participant Flow

Arm/Group Title	Case
Arm/Group Description	ketamine + Cystitis ketamine
Period Title: Overall Study
STARTED	44
COMPLETED	44
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Case
Arm/Group Description	ketamine + Cystitis ketamine
Overall Participants	44
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	44 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	28 (6)
Sex: Female, Male (Count of Participants)
Female	17 38.6%
Male	27 61.4%
Region of Enrollment (participants) [Number]
Taiwan	44 100%

Outcome Measures

1. Primary Outcome

Title	Substance Abuse Situation Record
Description	Substance abuse situation record: ketamine
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Case
Arm/Group Description	ketamine + Cystitis ketamine
Measure Participants	44
Mean (Full Range) [years]	2

2. Secondary Outcome

Title	Urinary Bladder Capacity
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Case
Arm/Group Description	ketamine + Cystitis ketamine
All Cause Mortality
	Case
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Case
	Affected / at Risk (%)	# Events
Total	0/44 (0%)
Other (Not Including Serious) Adverse Events
	Case
	Affected / at Risk (%)	# Events
Total	0/44 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.