UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001089
Receipt number R000001320
Scientific Title Effect of tiotropium on urinary retention in chronic obstructive pulmonary disease with micturition disorder
Date of disclosure of the study information 2008/03/19
Last modified on 2008/12/08 22:14:49

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Basic information

Public title

Effect of tiotropium on urinary retention in chronic obstructive pulmonary disease with micturition disorder

Acronym

Effect of tiotropium on urinary retention in COPD with micturition disorder

Scientific Title

Effect of tiotropium on urinary retention in chronic obstructive pulmonary disease with micturition disorder

Scientific Title:Acronym

Effect of tiotropium on urinary retention in COPD with micturition disorder

Region

Japan


Condition

Condition

COPD

Classification by specialty

Pneumology Urology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify whether or not inhaled tiotropium increases the urinary retention in COPD patients with micturition disorder

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

IPSS (International Prostate Symptom Score)
QOL index
Uroflowmetry

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

At the initial visit before the treatment and the visit after 4-week tiotropium administration, lower urinary symptoms and QOL were assessed.

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

50 years-old <=

Age-upper limit


Not applicable

Gender

Male

Key inclusion criteria

COPD patients who had been clinically diagnosed with benign prostatic hyperplasia at our institution were enrolled.

Key exclusion criteria

Patients with glaucoma, previous bladder or prostate surgery, bladder or prostate cancer, a history of urinary tract infections and serum prostate-specific antigen over 4 ng/ml were excluded.

Target sample size

25


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kingo Chida

Organization

Hamamatsu university school of medicine

Division name

Second Division, Department of Internal Medicine

Zip code


Address

1-20-1, Handayama, Higashiku, Hamamatsu, Shizuoka 431-3192, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Hamamatsu university school of medicine

Division name

Second Division, Department of Internal Medicine

Zip code


Address


TEL

053-435-2263

Homepage URL


Email



Sponsor or person

Institute

Second Division, Department of Internal Medicine, Hamamatsu university school of medicine

Institute

Department

Personal name



Funding Source

Organization

Second Division, Department of Internal Medicine, Hamamatsu university school of medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2008 Year 03 Month 19 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2007 Year 01 Month 01 Day

Date of IRB


Anticipated trial start date

2007 Year 01 Month 01 Day

Last follow-up date

2008 Year 12 Month 01 Day

Date of closure to data entry

2008 Year 12 Month 01 Day

Date trial data considered complete

2008 Year 12 Month 01 Day

Date analysis concluded

2008 Year 12 Month 01 Day


Other

Other related information



Management information

Registered date

2008 Year 03 Month 19 Day

Last modified on

2008 Year 12 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001320


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name