UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024578
Receipt number R000028285
Scientific Title Comparison of reduction effect on storage symptom between tadalafil and silodosin in men with benign prostate hyperplasia: A prospective randomized crossover study
Date of disclosure of the study information 2016/12/20
Last modified on 2022/11/02 10:35:59

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Basic information

Public title

Comparison of reduction effect on storage symptom between tadalafil and silodosin in men with benign prostate hyperplasia: A prospective randomized crossover study

Acronym

The RESTORE study

Scientific Title

Comparison of reduction effect on storage symptom between tadalafil and silodosin in men with benign prostate hyperplasia: A prospective randomized crossover study

Scientific Title:Acronym

The RESTORE study

Region

Japan


Condition

Condition

Benign prostate hyperplasia

Classification by specialty

Urology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the reduction effect on storage symptom between tadalafil and silodosin in men with benign prostate hyperplasia

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Variations of overacrive bladder symptom score (OABSS) at 8-week after the administration of each drug

Key secondary outcomes

Variations of the items below at 4-week and 8-week after the administraion of each drug
- International prostate symptom score (IPSS): Total score, Storage subscore, and Voiding subscore
- International Index of Erectile Function (IIEF)
- Maximum urinary flow rate
- Post-void residual urine
- Mean voided volume
- Blood pressure on visits


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking


Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

We will administer tadalafil 5mg/day for 8 weeks first and silodosin 8mg/day for 8 weeks second.

Interventions/Control_2

We will administer silodosin 8mg/day for 8 weeks first and tadalafil 5mg/day for 8 weeks second.

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

- Prostate volume is 20 mL and over.
- OABSS is 6 and over.

Key exclusion criteria

- Prostate cancer
- Neurogenic bladder
- Under treatment with alpha1 blockers and/or OAB drugs
- Contraindication of tadalafil

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Kazumasa
Middle name
Last name Torimoto

Organization

Nara Medical University Hospital

Division name

Urology

Zip code

634-8522

Address

840 Shijo-cho, Kashihara, Nara, JAPAN

TEL

+81-744-22-3051

Email

torimoto@naramed-u.ac.jp


Public contact

Name of contact person

1st name Kazumasa
Middle name
Last name Torimoto

Organization

Nara Medical University Hospital

Division name

Urology

Zip code

634-8522

Address

840 Shijo-cho, Kashihara, Nara, JAPAN

TEL

+81-744-22-3051

Homepage URL


Email

torimoto@naramed-u.ac.jp


Sponsor or person

Institute

Department of Urology, Nara Medical University

Institute

Department

Personal name



Funding Source

Organization

Department of Urology, Nara Medical University

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

Nara Medical University Certified Review Board

Address

840 Shijo-cho, Kashihara, Nara

Tel

+81-744-22-3051

Email

ethics_nara@naramed-u.ac.jp


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

奈良県立医科大学附属病院(奈良県)、平尾病院(奈良県)、高井病院(奈良県)、大阪暁明館病院(大阪府)


Other administrative information

Date of disclosure of the study information

2016 Year 12 Month 20 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

2016 Year 11 Month 28 Day

Date of IRB

2016 Year 11 Month 24 Day

Anticipated trial start date

2016 Year 12 Month 20 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 10 Month 26 Day

Last modified on

2022 Year 11 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028285


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name