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A clinical trial to compare the outcomes of transurethral resection of the prostate (TURP) and TURP plus Botox injection in patients with benign prostatic hyperplasia (BPH).

Protocol summary

Study aim
To compare the outcomes of transurethral resection of the prostate (TURP) and TURP plus Botox injection in benign prostatic hyperplasia (BPH) patients.
Design
In this pragmatic double-blind clinical trial, fifty patients with BPH were assigned into parallel groups using the table of random numbers in a community-based setting.
Settings and conduct
BPH patients at Imam Reza Hospital, Mashhad, Iran, were chosen. In this double-blind study, the clinical care provider and data collector were blind to group assignment and the type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age range of 50-80 years, lower urinary tract symptoms resistant to standard medical treatment, international prostate symptom score (IPSS) of > 12, and prostate volume of >50 cm3 in ultrasound. Exclusion criteria: History of prostate surgery, prostate cancer, bleeding disorders, and incidence of acute urinary retention during the treatment.
Intervention groups
The intervention Group I will undergo TURP. The intervention Group II will concurrently receive TURP and 300 U intravenous Botox at 30 different locations.
Main outcome variables
Evaluation and comparison of clinical symptoms (e.g., dysuria, urinary frequency, and pelvic pain) based on the IPSS 3, 6, and 12 months after the intervention in both groups.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110306005981N3
Registration date: 2018-12-25, 1397/10/04
Registration timing: prospective

Last update: 2018-12-25, 1397/10/04
Update count: 0
Registration date
2018-12-25, 1397/10/04
Registrant information
Name
Maliheh Keshvari Shirvan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 1761 5063
Email address
keshvarim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the outcomes of transurethral resection of the prostate (TURP) and TURP plus Botox injection in patients with benign prostatic hyperplasia (BPH).
Public title
Treatment of transurethral resection of the prostate.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range of 50-80 years Lower urinary tract symptoms resistant to standard medical treatment international prostate symptom score (IPSS) of >12 prostate volume of >50 cm3 in ultrasound
Exclusion criteria:
History of prostate surgery Having prostate cancer Having bleeding disorders Incidence of acute urinary retention during the treatment
Age
From 50 years old to 80 years old
Gender
Male
Phase
2
Groups that have been masked
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Fifty BPH patients at the Imam Reza Hospital, Mashhad, Iran, were chosen. The participants were allocated into two groups of intervention using the table of random numbers based on computer programs.
Blinding (investigator's opinion)
Double blinded
Blinding description
BPH patients at Imam Reza Hospital, Mashhad, Iran, were chosen. In this double-blind study, the clinical care provider and data collector were blind to group assignment and the type of treatment.
Placebo
Not used
Assignment
Parallel
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
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Approval date
2018-11-22, 1397/09/01
Ethics committee reference number
IR.MUMS.fm.REC.1396.317

Health conditions studied

1

Description of health condition studied
Prostatic hyperplasia
ICD-10 code
N40
ICD-10 code description
Hyperplasia of prostate

Primary outcomes

1

Description
Clinical symptoms (e.g., dysuria, urinary frequency, and pelvic pain)
Timepoint
3, 6, and 12 months after the intervention
Method of measurement
The international prognostic scoring system (IPSS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group I will receive of transurethral resection of the prostate treatment.
Category
Treatment - Surgery

2

Description
Intervention group: The intervention group II will receive of transurethral resection of the prostate with 300 U intravenous Botox at 30 different locations.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Majid Chogani
Street address
Imam Reza Hospital, Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 1761 5063
Email
majidchokani@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
913753459
Phone
+98 51 3841 1538
Email
vcresearch@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
Maliheh Keshvari Shirvan
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Imam Reza Hospital, Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 1761 5063
Email
keshvarim@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Chogani
Position
Residents
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Imam Reza Hospital, Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 1761 5063
Email
majidchokani@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Chogani
Position
Residents
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Imam Reza Hospital, Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 1761 5063
Email
majidchokani@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Not applicable
Title and more details about the data/document
The total data to be included are the primary and secondary effects to be shared.
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Our data will only be available to researchers working in science center and university.
Under which criteria data/document could be used
Our data will be available for scholars working in science center and university.
From where data/document is obtainable
Majid Chogani provides the analysis code to the applicants via email: majidchokani@yahoo.com
What processes are involved for a request to access data/document
Data collection was done for 10 months, data were collected one month, statistical analysis of one month, information dissemination as a article six months.
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