UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013015 |
|---|---|
| Receipt number | R000015193 |
| Scientific Title | The long-term effects of discontinuing alpha 1-blockers after improvement of lower urinary tract symptoms in males with BPH |
| Date of disclosure of the study information | 2014/02/01 |
| Last modified on | 2014/01/30 14:25:18 |
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Basic information
Public title
The long-term effects of discontinuing alpha 1-blockers after improvement of lower urinary tract symptoms in males with BPH
Acronym
LEDAB
Scientific Title
The long-term effects of discontinuing alpha 1-blockers after improvement of lower urinary tract symptoms in males with BPH
Scientific Title:Acronym
LEDAB
Region
| Japan |
Condition
Condition
Benign Prostatic Hyperplasia
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It has been widely accepted that alpha 1-adrenergic blockers (ABs) are useful in the treatment of lower urinary tract symptoms (LUTS) with benign prostatic hyperplasia (BPH). Previously published reports have advocated continued use of ABs for their effect to be maintained. Several reports suggested that complete cessation of ABs led to relapse of symptoms within 3 months. On the other hand, a few reports have shown that approximately half of patients could keep good condition at 6 months after discontinuation of ABs. Short-term discontinuation of AB medication is possible for the select patients with symptomatic improvement. ABs are now often used as a first line medical treatment for men affected by LUTS/BPH, however it is not elucidated how long medication should be continued.
No data have previously been published regarding the long-term effect of discontinuing ABs in LUTS patients who responded well to medication. The study objective was to show long-term effects of discontinuation of the ABs on LUTS in men with BPH treated effectively with ABs.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
International prostatic symptom score, QOL score, Prostatic volume, PSA value, Uroflowmetry, Residual urine
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
| Other |
Interventions/Control_1
discontinuatuin of medication
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male
Key inclusion criteria
Men with LUTS (IPSS:10 or more / QOL:4 or more) who had improvement after treatment (IPSS<10 / QOL<4) with daily alpha blockers in more than 40 years old.
Key exclusion criteria
prostate cancer, neuropathic bladder, urethral stricture, urinary retention, urinary tract infection
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiji Ogura |
Organization
Japanese Red Cross Otsu Hospital
Division name
Department of Urology
Zip code
Address
1-1-35, Nagara, Otsu, Japan
TEL
077-522-4131
k-ogura@otsu.jrc.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiji Ogura |
Organization
Japanese Red Cross Otsu Hospital
Division name
Department of Urology
Zip code
Address
1-1-35, Nagara, Otsu, Japan
TEL
077-522-4131
Homepage URL
k-ogura@otsu.jrc.or.jp
Sponsor or person
Institute
Japanese Red Cross Otsu Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
大津赤十字病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2003 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2003 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 30 | Day |
Last modified on
| 2014 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015193
