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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name