Peyronie's Disease more recently Chronic Inflammation of the Tunica Albuginea , is a connective tissue disorder involving the growth of fibrous plaques in the soft tissue of the penis, scar tissue forms in the tunica albuginea, the thick sheath of tissue surrounding the corpora covernosa causing pain, abnormal curvature, erectile dysfunction, indentation, loss of girth and shortening. A variety of treatments have been used, but none have been especially effective
Purpose: Test of Botox in treatment of peyronie
Method : 10 peyronie patients analyzed by sonography to determine the size of plague, curve of penis and sex intercourse satisfaction . then 100 unites of Botox is dissolved in 5ml normal saline, and injected in outside plaque and follow up the patient in 8 & 16 weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203129274N1
Registration date:2012-05-30, 1391/03/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-05-30, 1391/03/10
Registrant information
Name
Mehdi Yazdinejad
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1416 4950
Email address
yazdi.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapour University of Medical Sciences
Expected recruitment start date
2011-07-27, 1390/05/05
Expected recruitment end date
2012-03-10, 1390/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of botox in treating peyronie disease; a clinical trial
Public title
The efficacy of botox in treating peyronie disease; a clinnical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: stable peyronie plaque. Exclusion criteria : active phase of peyronie disease; less than 1 year history of peyronie disease and allegy to botox
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ahvaz jondishpour univercity of medical science
Street address
ahvaz jondishpour univercity of medical science, golestan, ahvaz
City
ahvaz
Postal code
6125733118
Approval date
2011-06-26, 1390/04/05
Ethics committee reference number
eth235
Health conditions studied
1
Description of health condition studied
peyronie disease
ICD-10 code
N48.6
ICD-10 code description
induratio penis plastica
Primary outcomes
1
Description
size of plaque
Timepoint
preinjection and postinjection(8,16 weeks later )
Method of measurement
with sonography , milimeter
2
Description
penile curvature
Timepoint
preinjection and postinjection(8,16 weeks later )
Method of measurement
with photography , degree
3
Description
imprvement of sexual intercourse
Timepoint
preinjection and postinjection(8,16 weeks later )
Method of measurement
clinical
Secondary outcomes
1
Description
side effect
Timepoint
preinjection and post injection (8 ,16 weeks later )
Method of measurement
clinical
Intervention groups
1
Description
patients were treated with 100 unith of botox in 5cc of normal saline (intralesional )
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Dr Mehdi Yazdinejad
Street address
Golestan hospital, Golestan
City
Ahvaz
2
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Dr Mehdi Yazdinejad
Street address
Azadegan street
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Ahvaz University of Medical Science and Health science
Full name of responsible person
Dr. Mostafa Feghi
Street address
Golestan
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Ahvaz University of Medical Science and Health science
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
Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Dr. Mehdi Yazdinejad
Position
MD
Other areas of specialty/work
Street address
No. 872, Ordibehesht street, Ahvaz
City
Ahvaz
Postal code
6165755813
Phone
+98 61 1416 4950
Fax
Email
yazdi.mehdi57@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Hosseini
Position
Associate Professor
Other areas of specialty/work
Street address
No. 69, Beheshti street, Mellirah, Ahvaz.
City
Ahvaz
Postal code
Phone
+98 61 1443 4977
Fax
Email
Hosseini-Mo@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Dr. Mehdi Yazdinejad
Position
MD
Other areas of specialty/work
Street address
No. 872, Ordibehesht street, Ahvaz
City
Ahvaz
Postal code
6165755813
Phone
+98 61 1416 4950
Fax
Email
yazdi.mehdi57@yahoo,com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)