UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021184
Receipt number R000024413
Scientific Title Evaluation Of Different Techniques Of Hyaluronic Acid Versus Saline Injection To Treat Lifelong Premature Ejaculation Patients: A Randomized Prospective Study
Date of disclosure of the study information 2016/02/24
Last modified on 2024/02/29 15:35:40

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Basic information

Public title

Evaluation Of Different Techniques Of Hyaluronic Acid Versus Saline Injection To Treat Lifelong Premature Ejaculation Patients: A Randomized Prospective Study

Acronym

fillers and lifelong premature ejaculation

Scientific Title

Evaluation Of Different Techniques Of Hyaluronic Acid Versus Saline Injection To Treat Lifelong Premature Ejaculation Patients: A Randomized Prospective Study

Scientific Title:Acronym

fillers and lifelong premature ejaculation

Region

Africa


Condition

Condition

male sexual dysfunction

Classification by specialty

Urology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

role of fillers in PE

Basic objectives2

Others

Basic objectives -Others

role of fillers in PE

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

role of fillers in PE

Key secondary outcomes

role of fillers in PE


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Group A patients (n=20) received a single injection of (2-4ml) of hyaluronic acid gel (23mg/ml) (Revofil Ultra Volume Body Contour Gel, Caregen Co., South Korea) by fan injection technique (with 30 G needle)

Interventions/Control_2

Group B patients (n=20) also received a single injection of (2-4ml) of hyaluronic acid gel (23mg/ml) (Revofil Ultra Volume Body Contour Gel, Caregen Co., South Korea) with (30 G needle)

Interventions/Control_3

Group C patients (n = 20) received a single injection of a normal saline (0.9%) solution with (30 G needle) at both (the proximal one third of the glans penis by fan injection technique, and at the coronal sulcus and frenulum) for full glans penis augmentation

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

60 years-old >=

Gender

Male

Key inclusion criteria

Patients with lifelong PE

Key exclusion criteria

Patients with ED

Target sample size

60


Research contact person

Name of lead principal investigator

1st name sameh
Middle name fayek
Last name gamalel din

Organization

Cairo University

Division name

Andrology & STDs

Zip code

202

Address

Kasr Alaini street

TEL

01227109309

Email

samehfayek@hotmail.com


Public contact

Name of contact person

1st name sameh
Middle name fayek
Last name gamalel din

Organization

Cairo University

Division name

Andrology department

Zip code

202

Address

Kasr AlAini street

TEL

01227109309

Homepage URL

http://scholar.cu.edu.eg/sfayek/

Email

samehfayek@kasralainy.edu.cu.eg


Sponsor or person

Institute

Al-Azhar University, Faculty of Medicine

Institute

Department

Personal name



Funding Source

Organization

Al-Azhar University, Faculty of Medicine

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

Al-Azhar University, Faculty of medicine, Cairo, Egypt

Address

Al - Mahameer Street, Gameat Al Azhar, Nasr City, Cairo Governorate

Tel

+20 2 904 051

Email

ahmedandro@yahoo.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

Andrology & Dermatology & Venereology AlAzhar University faculty of medicine


Other administrative information

Date of disclosure of the study information

2016 Year 02 Month 24 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

Terminated

Date of protocol fixation

2018 Year 02 Month 23 Day

Date of IRB

2018 Year 03 Month 19 Day

Anticipated trial start date

2018 Year 03 Month 19 Day

Last follow-up date

2019 Year 10 Month 26 Day

Date of closure to data entry

2019 Year 11 Month 01 Day

Date trial data considered complete

2019 Year 11 Month 15 Day

Date analysis concluded

2019 Year 11 Month 15 Day


Other

Other related information



Management information

Registered date

2016 Year 02 Month 24 Day

Last modified on

2024 Year 02 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024413


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name