compare of effectiveness of verapamil alone and with vacuum in treatment of peyronie 's disease
Design
Two crossover group non randomized trial with non blind clinical trial
Settings and conduct
Patient with peyronie's disease splitted to 2 group one group treated with verapamil and second group treated with verapamil and vacuum in golestan hospital of medical university of Ahvaz without blindness.
Participants/Inclusion and exclusion criteria
patient must have curvature lesser than 90 c to dorsal or lateral. plaque have stable or patient have plaque for at least more than 6 months. patient was removed from this trial if have recent diagnosed for this disease ; patient have calcified plaque for all part of penis ; patient have ventral curvature ; patient have erection dysfunction that did not respond to oral agent or ICI.
Intervention groups
Patient have peyronie's disease and condition to income study , divided to 2 group. group 1 receive verapamil weekly and second group receive verapamil and vacuum weekly.
Main outcome variables
Penile curvature was determined , compared by software before and after treatment.
Pain was defined with scale 0-10.
Plaque size was define with sonography before and after study.
Erectile dysfunction was determined by Questionnaire that taken from patient.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200316046786N1
Registration date:2020-06-21, 1399/04/01
Registration timing:retrospective
Last update:2020-06-21, 1399/04/01
Update count:0
Registration date
2020-06-21, 1399/04/01
Registrant information
Name
Hamed Karimi afshar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3011
Email address
karimiafshar.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-17, 1398/11/28
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
2020-02-17, 1398/11/28
Actual recruitment end date
2020-04-20, 1399/02/01
Trial completion date
2020-04-20, 1399/02/01
Scientific title
Effectiveness of verapamil compare with verapamil and vacuum in the treatment of Peyronie's disease
Public title
Effective of verapamil combination with vacuum for treatment of peyronie's disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patient have peyronie's disease at least 6 months
All patient have 90 c curvature in penis.
Exclusion criteria:
Patient have plaque in all part of penis
patient have ventral curvature.
patient have erection dysfunction with peyronie disease that have not respond to oral agent or ICI.
Age
No age limit
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Golestan Ave., Saheli Blvd.,
City
Ahvaz
Province
Khouzestan
Postal code
6135715771
Approval date
2020-02-17, 1398/11/28
Ethics committee reference number
IR.AJUMS.REC.1398.883
Health conditions studied
1
Description of health condition studied
Peyronie disease
ICD-10 code
N48.9
ICD-10 code description
Disorder of penis, unspecified
Primary outcomes
1
Description
diffrence in curvature of penis picture before and after trial
Timepoint
before trial and 6 week after trial
Method of measurement
patient take photo from his penis curvature.
Secondary outcomes
empty
Intervention groups
1
Description
Control group: patient have peyronie's disease and have routine treatment of verapamil 10mg each week for 6 weeks.
Category
Treatment - Drugs
2
Description
Intervention group: patient have peyronire's disease that receive combination therapy by verapamil 10mg each week for 6 weeks and use vacuum for 3 time of week for 10 min each 6 week.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Seyed mokhtar hossini
Street address
Golestan Ave., Saheli Blvd.,
City
Ahvaz
Province
Khouzestan
Postal code
6135715771
Phone
+98 61 3374 3033
Fax
+98 61 3374 3033
Email
hamedkarimiafshar@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
mohamad badavi
Street address
Golestan Ave., Saheli Blvd.,
City
Ahvaz
Province
Khouzestan
Postal code
6135715771
Phone
+98 61 3374 3033
Email
hamedkarimiafshar@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Seyed mokhtar hossini
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Golestan Ave., Saheli Blvd.,
City
Ahvaz
Province
Khouzestan
Postal code
6135715771
Phone
+98 61 3374 3033
Email
hamedkarimiafshar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Seyed mokhtar hossini
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Golestan Ave., Saheli Blvd.,
City
Ahvaz
Province
Khouzestan
Postal code
6135715771
Phone
+98 61 3374 3033
Email
hamedkarimiafshar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Seyed mokhtar hossini
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Golestan Ave., Saheli Blvd.,
City
Ahvaz
Province
Khouzestan
Postal code
6135715771
Phone
+98 61 3374 3033
Email
hamedkarimiashar@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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available