Comparison of the therapeutic effect of verapamil and triamcinolone drugs and their simultaneous use with macroneedling in patients with Peyronie's plaque
Determining the therapeutic effect of verapamil and triamcinolone drugs and investigating their simultaneous use with macroneedling in patients with Peyronie's plaque.
Design
The study is conducted as a clinical trial with a control group, with parallel groups, double-blind, randomized, on 60 patients. RNG plugin is used for randomization in excel software.
Settings and conduct
60 eligible patients who were selected from the patients referred to the Shahada Tajrish Hospital clinic in Tehran were randomly assigned to the intervention group or the control group. Standard medical treatment will be given to all patients, as well as the consent form will be explained to all patients about the process of intervention and the complications caused by it. Before the intervention and after the intervention, patients' information including the size of the plaque before and after the treatment, the amount of penile curvature before and after the treatment, the amount of erectile dysfunction before And after the treatment، (IIEF-5), the amount of pain during erection(VAS)is collected.
Participants/Inclusion and exclusion criteria
Entry requirements:
Patients with Peyronie's plaque confirmed by ultrasound referring to Tajrish Martyrs Hospital
Age 20-65 years
Non-entry conditions:
Having a history of trauma and fracture of the penis
Having a history of previous surgery on the penis
Having a history of pelvic radiotherapy
Intervention groups
The intervention is performed by macroneedling and by a needle with a length of 8-10 mm
The intervention process includes the injection of verapamil and triamcinolone drugs along with macroneedling technique 6 times a week at the site.
In the control group, only verapamil and triamcinolone injections are performed
Main outcome variables
Erectile dysfunction; Pain; Curvature of the penis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230408057854N1
Registration date:2023-05-11, 1402/02/21
Registration timing:prospective
Last update:2023-05-11, 1402/02/21
Update count:0
Registration date
2023-05-11, 1402/02/21
Registrant information
Name
hossein rahnama
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3282 2705
Email address
drhossein2020@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2024-05-21, 1403/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the therapeutic effect of verapamil and triamcinolone drugs and their simultaneous use with macroneedling in patients with Peyronie's plaque
Public title
The therapeutic effect of verapamil and triamcinolone along with macroneedling in the treatment of Peyronie's plaque
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from Peyronie's plaque confirmed by ultrasound
Age between 20-65 years
Exclusion criteria:
History of trauma and penis fracture
History of previous surgery on the penis
History of pelvic radiotherapy
Age
From 20 years old to 65 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
First, by using the Random number generation plugin in Excel software, a table of random numbers from 1 to 60 is prepared in a non-sequential and scattered manner, and intervention and control are done by assigning numbers to two groups of 60 people. The randomization process is done by the study methodology consultant, and the clinical researchers do not know about the randomization process, and only randomized codes from 1 to 60 will be provided to them.
Blinding (investigator's opinion)
Double blinded
Blinding description
fter selecting the samples, none of the sampled people will know about randomization and the process of allocation to groups. Doctors are given a table of coded numbers in advance and patients are included in the study in the order of the numbers in the table. Therefore, the present study is double-blind. All patients receive routine medical treatment, but the macroneedling technique is performed for the case group, but this procedure is not performed for the control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences Ethics Committee
Street address
Shahid Beheshti University of Medical Sciences, Taleghani Street, Valenjak
City
Tehran
Province
Tehran
Postal code
۱۹۸۹۹۳۴۱۴۸
Approval date
2022-11-29, 1401/09/08
Ethics committee reference number
IR.SBMU.MSP.REC.1401.452
Health conditions studied
1
Description of health condition studied
Peyronie's plaque
ICD-10 code
N48.6
ICD-10 code description
Peyronie's disease
Primary outcomes
1
Description
Peyronie's Plaque size
Timepoint
6 weeks after the start of treatment
Method of measurement
By Penile ultrasound
Secondary outcomes
1
Description
The amount of curvature of the penis
Timepoint
6 weeks after the start of treatment
Method of measurement
Objective measurement by ruler
Intervention groups
1
Description
Intervention group: use of macroneedling
Category
Treatment - Other
2
Description
Control group: Treatment with triamcinolone and verapamil
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada tajrish hospital
Full name of responsible person
Hossein Rahnama
Street address
Shohada Tajrish Hospital, Shahradari St. Postal code 1989934148
City
Tehran
Province
Tehran
Postal code
۱۹۸۹۹۳۴۱۴۸
Phone
+98 21 2271 8000
Email
rahnama2010@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
nasrin khateri
Street address
Shohada Tajrish Hospital, Shahradari St. Postal code1989934148
City
Tehran
Province
Tehran
Postal code
۱۹۸۹۹۳۴۱۴۸
Phone
+98 21 2387 2523
Email
rahnama2010@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hossein Rahnama
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Shohada Tajrish Hospital, Shahradari St. Postal code1989934148
City
Tehran
Province
Tehran
Postal code
۱۹۸۹۹۳۴۱۴۸
Phone
+98 21 2271 8002
Email
rahnama2010@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
حسین رهنما
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Shohada Tajrish Hospital, Shahradari St. Postal code1989934148
City
Tehran
Province
Tehran
Postal code
۱۹۸۹۹۳۴۱۴۸
Phone
+98 21 2271 8002
Email
rahnama2010@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hossein Rahnama
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Shohada Tajrish Hospital, Shahradari St. Postal code1989934148
City
Tehran
Province
Tehran
Postal code
۱۹۸۹۹۳۴۱۴۸
Phone
+98 21 2271 8002
Email
rahnama2010@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts immediately after the results are printed
To whom data/document is available
All researchers
Under which criteria data/document could be used
Any use of documents should be done in coordination with the researcher
From where data/document is obtainable
Hossein Rahnama via the email address below rahnama2010@gmail.com
What processes are involved for a request to access data/document