Effects of intra-prostate botulinum toxin injection in patients with benign prostatic hyperplasia
Design
Randomized clinical trial without control group
Settings and conduct
This study was performed on 17 men with benign prostate enlargement at Mashhad Imam Reza Hospital.This method combines 200 units of botulinum toxin with 30 cc normal saline. then injected into the prostate through the urethra
Participants/Inclusion and exclusion criteria
Men with benign prostate hyperplasia who have irritable and obstructive symptoms.
Men who have prostate cancer at the same time are excluded
Intervention groups
In this study, we evaluated the efficacy of intra-prostate Botox injection on urinary irritant and obstructive symptoms.
Also changes in prostate size, urinary residual rate, and psa before and after injection were measured.
Main outcome variables
Determination of International Prostate Symptom Score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190813044522N1
Registration date:2019-10-05, 1398/07/13
Registration timing:registered_while_recruiting
Last update:2019-10-05, 1398/07/13
Update count:0
Registration date
2019-10-05, 1398/07/13
Registrant information
Name
Amin Nowbahar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3858 3885
Email address
nobahara951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-13, 1398/02/23
Expected recruitment end date
2020-05-19, 1399/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of intra-prostate botulinum toxin injection in patients with benign prostatic hyperplasia
Public title
The effect of intra-prostate Botox injection on the treatment of benign prostatic hyperplasia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All men with benign prostate hyperplasia who have been treated for the first time
Exclusion criteria:
The simultaneous presence of prostate cancer
Concomitant active urinary tract infection
Previous history of prostate surgery
Acute prostatitis
Age
No age limit
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
17
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
Ethics committee of mashhad University of Medical Sciences
Street address
Ebne sina
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Approval date
2019-08-13, 1398/05/22
Ethics committee reference number
ir.mums.medical.rec.1397.521
Health conditions studied
1
Description of health condition studied
Benign prostate hyperplasia
ICD-10 code
N40
ICD-10 code description
Enlarged prostate
Primary outcomes
1
Description
The rate of improvement of irritable and obstructive symptoms of urine
Timepoint
Measurement of prostate size, psa and urinary residual valume, as well as irritable and obstructive symptoms of urine before and 3 and 9 months after injection
Method of measurement
A questionnaire containing patient information;International Prostate Symptom Score( IPSS); psa; and urinary residual
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 200 units of botulinum toxin in combination with 30 cc normal saline injected into the prostate through the urethra.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
imam reza hospital
Full name of responsible person
amin nowbahar
Street address
Ebne sina ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3858 3885
Email
nobahara951@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen tafaghodi
Street address
daneshgah ave;Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3858 3885
Email
nobahara951@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Amin nowbahar
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Ebne sina ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3858 3885
Email
nobahara951@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
salman soltani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Ebne sina Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3858 3885
Email
soltanis@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amin Nowbahar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Ebne sina Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3858 3885
Email
nobahara951@mums.ac.ir
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