CystitisNCT00957333

Effects of Ketamine on Human Bladders and Its Possible Mechanisms

An observational study of Cystitis, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Cystitis
What is being tested?: ketamine
How many people: 44 participants
Where: 1 siteTaiwan
Study dates: Mar 2009to Dec 2011
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: primary care clinic

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Taipei Medical University-Wan Fang Hospital
Taipei

Other trials in Taiwan

About this study

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

Conditions: Cystitis
Being tested: ketamine
Keywords: ketamine, bladder dysfunction, bladder mucosa, mechanisms
Medical subject headings: Cystitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ketamineOther

Study groups in NCT00957333
Study group	Role	What they receive
case		ketamine + Cystitis Receives: Other: ketamine

What is being measured

The primary outcome is the main question the study is designed to answer.

Substance Abuse Situation Record
Substance abuse situation record: ketamine
Measured: 1 day

Secondary outcomes (1)

Urinary Bladder Capacity
Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2009Dec 2011

First posted12 Aug 2009 (estimated)
Study startMar 2009
Primary completionDec 2009
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CystitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Cross-sectional
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00957333
Sponsor's protocol ID: DOH98-NNB-1049
Status last verified: Nov 2010
First submitted: 3 Aug 2009
Last updated: 14 Jan 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)
Bladder Cancer, Prostate Cancer
Enrolling by invitationObservational study
Migraine Medication Effects on Urinary Symptoms
Overactive Bladder, Bladder Pain Syndrome
Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Recruiting
Investigation of PEMF Therapy for Female Patients With IC/BPS
Interstitial Cystitis, Chronic Interstitial Cystitis
Recruiting
Aerobic Exercise and Connective Tissue Massage in Painful Bladder Syndrome
Bladder Pain Syndrome, Painful Bladder Syndrome

All Cystitis trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Ketamine on Human Bladders and Its Possible Mechanisms
ClinicalTrials.gov ID: NCT00957333
Acronym / sponsor ID: DOH98-NNB-1049
Conditions: Cystitis
Keywords: ketamine, bladder dysfunction, bladder mucosa, mechanisms
Study type: Observational
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Taipei Medical University WanFang HospitalUniversity, hospital or other
Study start: Mar 2009
Primary completion: Dec 2009 (actual)
Study completion: Dec 2011 (actual)
First posted: 12 Aug 2009 (estimated)
Results: Posted 14 Jan 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Case only
Time perspective: Cross-sectional
Number of arms: 1

Arm	Type	Receives
case	–	Other: ketamineketamine + Cystitis

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: primary care clinic

Key inclusion criteria (4 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ketamine	Other	case

Primary outcome

Substance Abuse Situation Record
Time frame: 1 day
Substance abuse situation record: ketamine

1 secondary outcome

Urinary Bladder Capacity
Time frame: 1 day

Results and safety

Results posted to the registry on 14 Jan 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Case	44	44

Primary outcome: Substance Abuse Situation Record

Time frame: 1 day. Mean (Full Range). Unit: years

Measure	Case n = 44
Value	2 (0.5 to 5)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Case	0 of 44 (0%)	0 of 44 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Cystitis

Active, not recruiting
Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)
Bladder Cancer, Prostate Cancer
Enrolling by invitationObservational study
Migraine Medication Effects on Urinary Symptoms
Overactive Bladder, Bladder Pain Syndrome
Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Recruiting
Investigation of PEMF Therapy for Female Patients With IC/BPS
Interstitial Cystitis, Chronic Interstitial Cystitis
Recruiting
Aerobic Exercise and Connective Tissue Massage in Painful Bladder Syndrome
Bladder Pain Syndrome, Painful Bladder Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ruei-Ming Chen, PhD principal investigator

Taipei Medical University-Wan Fang Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cystitis, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Substance Abuse Situation Record (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00957333.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2016.