UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047183 |
|---|---|
| Receipt number | R000052811 |
| Scientific Title | A feasibility study on a smartphone treatment application for psychogenic erectile dysfunction |
| Date of disclosure of the study information | 2022/03/23 |
| Last modified on | 2024/03/18 16:22:35 |
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Basic information
Public title
A feasibility study on a smartphone treatment application for psychogenic erectile dysfunction
Acronym
A feasibility study on a smartphone treatment application for psychogenic erectile dysfunction
Scientific Title
A feasibility study on a smartphone treatment application for psychogenic erectile dysfunction
Scientific Title:Acronym
A feasibility study on a smartphone treatment application for psychogenic erectile dysfunction
Region
| Japan |
Condition
Condition
Psychogenic erectile dysfunction
Classification by specialty
| Psychosomatic Internal Medicine | Obstetrics and Gynecology | Psychiatry |
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop and examine the feasibility of a smartphone application which provides self-help cognitive behavior therapy to psychogenic erectile dysfunction patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in the IIEF-15 score from pre- to post-8 week and at the 1-month, 3-month, and 6-month follow-ups
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
| Behavior,custom |
Interventions/Control_1
An 8-week self-help cognitive behavior therapy app for psychogenic ED will be provided.
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
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male
Key inclusion criteria
Patients who meet the following conditions will be eligible for participation.
1. Those who meet the diagnostic criteria for situational ED according to DSM-5.
2. Those with mild to moderate symptoms (12 to 21 points) on the IIEF-5 score and are capable of morning erection and situational erection.
Key exclusion criteria
Those meeting any of the items below.
1. Those receiving or attending any other psychological treatment or clinical trials.
2. Those with a diagnosis of hypertensive disease, heart disease (excluding hypertensive), cerebrovascular disease, chronic kidney disease, or diabetes mellitus.
3. Those with suspicions of alcohol or drug abuse.
4. Those whose participation judged inappropriate for any other reason by their primary care physician.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Kumano |
Organization
Waseda University
Division name
Faculty of Human Science
Zip code
359-1192
Address
2-579-15, Mikajima, Tokorozawa, Saitama
TEL
04-2949-8113
hikumano@waseda.jp
Public contact
Name of contact person
| 1st name | Junichi |
| Middle name | |
| Last name | Saito |
Organization
Waseda University
Division name
Comprehensive Research Organization
Zip code
359-1192
Address
2-579-15, Mikajima, Tokorozawa, Saitama
TEL
04-2949-8113
Homepage URL
tekuteke@aoni.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Logos Science Corp.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Com mittee , Waseda University
Address
2-579-15, Mikajima, Tokorozawa, Saitama
Tel
03-5272-1639
rinri@list.waseda.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 23 | 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
8
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
| 2021 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2023 | 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
| 2022 | Year | 03 | Month | 16 | Day |
Last modified on
| 2024 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052811
