UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043877 |
|---|---|
| Receipt number | R000050094 |
| Scientific Title | A Randomized Crossover Trial of the Efficacy of Device Masturbation in Patients with Difficult Ejaculation |
| Date of disclosure of the study information | 2021/04/09 |
| Last modified on | 2022/10/12 11:20:57 |
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Basic information
Public title
A Randomized Crossover Trial of the Efficacy of Device Masturbation in Patients with Difficult Ejaculation
Acronym
A Randomized Crossover Trial of the Efficacy of Device Masturbation in Patients with Difficult Ejaculation
Scientific Title
A Randomized Crossover Trial of the Efficacy of Device Masturbation in Patients with Difficult Ejaculation
Scientific Title:Acronym
A Randomized Crossover Trial of the Efficacy of Device Masturbation in Patients with Difficult Ejaculation
Region
| Japan |
Condition
Condition
Infertility
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To conduct a practical study of the efficacy of manual and device-based masturbation on ejaculation in male patients who experience ejaculation difficulties during masturbation during fertility treatment using a randomized crossover study design.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Reduction in the difficulty of masturbation as measured by the visual analog scale (VAS).
Key secondary outcomes
Maximum penile hardness, semen testing parameters, and safety
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
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Each patient's normal method of masturbation.
Interventions/Control_2
A method of masturbation in which the penis is stimulated with a masturbation device while a medical condom is attached to the erect penis and ejaculated into the medical condom.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Self-identification of ejaculation difficulties during masturbation (confirmed by medical history) with little or no history of erectile dysfunction medication or device masturbation.
Key exclusion criteria
(1) regular use of erectile dysfunction medication, (2) unwillingness to masturbate with a device, (3) history of diabetes, (4) history of malignant disease, (5) history of depression, (6) other factors that may interfere with participation in the clinical trial
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Shinnosuke |
| Middle name | |
| Last name | Komiya |
Organization
HORAC Grand Front Osaka Clinic
Division name
Gynecology
Zip code
5300011
Address
Grand Front Osaka Tower B15F, 3-1 Ohfuka-cho, Kita-ku, Osaka City
TEL
+81663778824
komiya520@ivfjapan.com
Public contact
Name of contact person
| 1st name | Shinnosuke |
| Middle name | |
| Last name | Komiya |
Organization
HORAC Grand Front Osaka Clinic
Division name
Gynecology
Zip code
530-0011
Address
Grand Front Osaka Tower B15F, 3-1 Ohfuka-cho, Kita-ku, Osaka City
TEL
+81663778824
Homepage URL
komiya0703@gmail.com
Sponsor or person
Institute
HORAC Grand Front Osaka Clinic
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
Medical Corporation Sankeikai IRB
Address
Grand Front Osaka Tower B15F, 3-1 Ohfuka-cho, Kita-ku, Osaka City
Tel
+81663778824
komiya0703@gmail.com
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
HORACグランフロント大阪クリニック（大阪府）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 09 | 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
12
Results
No significant differences in semen findings were found.
Results date posted
| 2022 | Year | 10 | Month | 12 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
The paper is currently being submitted for publication.
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 | 03 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 09 | Day |
Last modified on
| 2022 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050094
