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 |
* 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
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
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/
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
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
