Treatment of patients with chronic prostatitis by effective methods
Design
The study is conducted as a clinical trial with a control group in parallel on 60 patients
Settings and conduct
60 eligible patients are randomly assigned to the intervention group or the control group, and this process continues until the sample size is completed. 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. All patients will have the permission to withdraw from the intervention at any time after hearing the explanation of the project manager. When diagnosed and before starting the treatment, a questionnaire related to chronic prostatitis (NIH-CPSI score) will be filled and after the end of the course Re-treatment of this questionnaire completion and necessary comparisons in resolving the symptoms of the patient's face
Participants/Inclusion and exclusion criteria
Inclusion criteria include age between 20-65 years. Has symptoms of chronic prostatitis
Exclusion criteria: history of urological surgery leading to regional nerve amputation, regional vascular injury
A history of trauma to the genital area that caused neurological or vascular defects in the area
History of medical diseases (diabetes, high blood pressure, blood lipid disorders, thyroid disorders and severe depression
Intervention groups
The intervention in the form of Higgs energy transfer with the help of vibratory stimulation (PV) embedded in the Orthofix device, is introduced by two arms, simultaneously, to both the lower and upper levels of the penis, which is carried out. patients are treated twice a week for a period of 5 consecutive sessions. Standard medical treatment will be given to all patients.Standard medical treatment will be given to control group.
Main outcome variables
prostatitis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230408057854N2
Registration date:2023-05-13, 1402/02/23
Registration timing:prospective
Last update:2023-05-13, 1402/02/23
Update count:0
Registration date
2023-05-13, 1402/02/23
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
2023-06-22, 1402/04/01
Expected recruitment end date
2024-06-21, 1403/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Erectofix device in solving prostatitis symptoms and complications
Public title
Evaluation of the effect of Erectofix device in solving prostate Inflammation symptoms and complications
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20-65 years
Have symptoms of chronic prostatitis
Exclusion criteria:
History of urological surgery leading to regional nerve cutting, regional vascular damage
A history of trauma to the genital area that caused neurological or vascular defects in the area
History of medical diseases (diabetes, high blood pressure, blood lipid disorders, thyroid disorders and severe depression)
Age
From 20 years old to 65 years old
Gender
Male
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
60
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)
Single blinded
Blinding description
After 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 and all patients are placed under the Orthofix device, but the desired wavelength is given to the case group, but not to 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