Protocol summary

Summary
The purpose of this study was to determine the effectiveness of adding laser therapy to intraperitoneal injection of verapamil in patients with Peyronie’s Disease. Inclusion criteria are all patients with a Peyronie’s Disease who were over 18 years of age and had at least 6 months of it. By urologist, they have been clinically examined and measured the size of plaque by ultrasound. Exclusion criteria are patients who have a Peyronie’s Disease and receive multiple treatments, a skin disorder in the penis, a history of Skin inflammatory diseases, uncontrolled hypertension. 80 patients with plaque after having informed consent based on Inclusion criteria using simple denture technique with non-transparent envelopes divided into verapamil injections and simultaneous laser treatment group or injecting with silent laser group and According to the protocol, it is treated by a urologist and a specialist in the physical medicine unit and the variables such as plaque size, deviation and pain in sexual activity, sexual satisfaction will be considered one month and three months after treatment. In the treatment group for 6 Weeks, two sessions in a week, 1064 lasers with a power of 0.5 watts and a dose of 50 jules per square centimeter in an area of ​​one square with 1 minute and 40 seconds per session is performed with a BTL-6000 high intensity LASER 12W and a 10 mm probe. Six injections of intraperitoneally injected verapamil with insulin needle will be done weekly. In the control group, only the standard treatment for verapamil injection is performed and the laser probe is placed on the plaque only with red light. Response to treatment will check one month and three months after treatment by measurements of pain, plaque size by ultrasound by a single radiologist, deformity, duration of illness and sexual function based on the size of the plaque and the curvature of the penis, Based on the lateral image of the penis and using the Photoshop software.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201710088146N27
Registration date: 2017-10-13, 1396/07/21
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-10-13, 1396/07/21
Registrant information
Name
Mohammadreza Razaghi
Name of organization / entity
Laser application in medical sciences research center
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8021
Email address
laser.cntr@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of treatment efficacy of Nd-YAG laser beside intra lesion Verapamil injection in Peyronie’s Disease patients referring to Shohada-e-Tajrish hospital : a randomized clinical trial
Public title
Efficacy of Nd-YAG Laser with Verapamil in Peyronie’s Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: All Patients with Peyronie's Disease; aged 18 years and over; have at least Peyronie's Disease for 6 months ; Exclusion criteria: Patients with a Peyronie's Disease and receive multiple treatments; Skin disorder in the penis; History of Inflammatory diseases of the skin; uncontrolled hypertension; history of heart attacks in the last one month; patients with acute phase or released fibrosis plaque during the penis; patients who are not satisfied to entering the study;
Age
From 18 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Organizational committee of ethics in biomedical research Shahid Beheshti University of Medical Scie
Street address
Next to Ayatollah Taleghani Hospital, Shahid Arabi ST. Yemen street, Shahid Chamran highway, Tehran
City
Tehran
Postal code
Approval date
2017-08-06, 1396/05/15
Ethics committee reference number
IR.SBMU.RETECH.REC.1396.285

Health conditions studied

1

Description of health condition studied
Peyronie’s Disease
ICD-10 code
N48.6
ICD-10 code description
Induratio penis plastica

Primary outcomes

1

Description
Plaque size
Timepoint
One month and three months after the end of treatment
Method of measurement
sonography

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the treatment group for 6 weeks , two sessions in a week,1064 laser with a power of 0.5 watts and a dose of 50 jules per square centimeter in an area of 1 centimeter square with a time of 1 minute and 40 seconds per session with a BTL-6000 high intensity LASER 12W, and 10mm probe, and 6 injections of verapamil intra-lesion with insulin needle will be performed weekly.
Category
Treatment - Other

2

Description
Control group: The only standard treatment for verapamil injection is done and the laser probe is placed on the plaque with red light only.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Laser Application Research Center in Medical Sciences
Full name of responsible person
Dr.Farzad Allameh
Street address
Shohadaye Tajrish Hospital, Tajrish, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
Next to Ayatollah Taleghani Hospital, Shahid Arabi ST. Yemen street, Shahid Chamran highway, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Laser Application Research Center in Medical Science
Full name of responsible person
Dr.Farzad Allameh
Position
urologist
Other areas of specialty/work
Street address
Shohadaye Tajrish Hospital, Tajrish, Tehran
City
Teharn
Postal code
Phone
+98 21 2274 9221
Fax
Email
laser.cntr@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Laser Application Research Centre in Medical Sciences
Full name of responsible person
Dr.Farzad Allameh
Position
urologist
Other areas of specialty/work
Street address
Shohadaye Tajrish Hospital, Tajrish, Tehran
City
Teharn
Postal code
Phone
+98 21 2274 9221
Fax
Email
laser.cntr@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Laser Application Research Centre in Medical Sciences
Full name of responsible person
Dr.Farzad Allameh
Position
urologist
Other areas of specialty/work
Street address
Shohadaye Tajrish Hospital, Tajrish, Tehran
City
Tehran
Postal code
Phone
+98 21 2274 9221
Fax
Email
laser.cntr@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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