1. Home
  2. Approved trials
  3. » فارسی

Determination of Cyproterone acetate effect to prevent recurrent urinary retention in patients with Benign Prostatic Hypertrophy.

Protocol summary

Study aim
Determination of Cyproterone acetate effect to prevent recurrent urinary retention in patients with benign prostatic hypertrophy
Design
Clinical trial with control group, based on clients referred to the hospital, with groups, simple randomised,With a sample size of 84, Phase 3 Clinical Trial
Settings and conduct
A study on patients who complained of acute urinary retention to ًQuaem Hospital's Urology Emergency in Mashhad with a primary diagnosis of Benign Prostatic Hypertrophy .After insertion of a Urinary catheter, the patients in the intervention group are treated with cyproterone acetate and tamsulusin, and the patients in the control group are treated with thamsulosin, and then all patients are examined after one week and again one month later, followed by 6 months for second urinary retention and the need for surgical intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with acute urinary retention complaints with primary diagnosis of BPH / Exclusion criteria: prostate cancer or urinary tract infections or , sympathomimetic drugs use.
Intervention groups
Intervention group: After insertion of a Urinary catheter, patients are treated with 1mg per kg per day oral Cyproterone acetate, combined with 0.4 mg per day Tamsulosin capsule for 4 weeks. Then Tamsulosin treatment is continued for up to 6 months. The urinary catheter is removed a week after insertion. Control group: After insertion of a Urinary catheter, patients are treated with 0.4 mg per day Tamsulosin capsules for 6 months. The urinary catheter is removed a week after insertion
Main outcome variables
The main variable is the reappearance of urinary retention. Other variables that are used to diagnose urinary tract obstruction include Frequency, intermittency, Urgency, straining, and Urinary flow force.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181106041572N1
Registration date: 2019-04-30, 1398/02/10
Registration timing: registered_while_recruiting

Last update: 2019-04-30, 1398/02/10
Update count: 0
Registration date
2019-04-30, 1398/02/10
Registrant information
Name
Amin Korooji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3868 9405
Email address
karojia941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-09, 1398/01/20
Expected recruitment end date
2019-05-10, 1398/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of Cyproterone acetate effect to prevent recurrent urinary retention in patients with Benign Prostatic Hypertrophy.
Public title
Effect of Cyproterone acetate in patients with Benign Prostatic Hypertrophy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with acute urinary retention complaints with initial diagnosis of BPH.
Exclusion criteria:
Prostate cancer Urinary infections Use of sympathomimetic drugs
Age
From 50 years old to 75 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 84
Randomization (investigator's opinion)
Randomized
Randomization description
Using a simple randomization method, With several envelopes are printed with the contents of the cards that are divided equally between the intervention and the control group, and People are evenly divided into two groups by shuffling and selecting the envelope. In order to hide Sealed and opaque envelopes with random sequences are used.
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 Mashhad University of Medical Sciences
Street address
Qureishi Building, Oppsite of Daneshgah 18 Ave, Daneshgah Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
345 - 91357
Approval date
2018-10-06, 1397/07/14
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.655

Health conditions studied

1

Description of health condition studied
Benign Prostate Hypertrophy
ICD-10 code
N40
ICD-10 code description
Enlarged prostate

Primary outcomes

1

Description
urinary retention
Timepoint
checking of urinary retention immediately after removal of urinary catheter 7 days after starting of cyproterone acetate with ureteral catheter and re-examination one week and 4 weeks after it and follow up to 6 months later.
Method of measurement
Observation

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:Patients who complained of acute urinary retention are referred to the Urology Emergency Department of Quaem Hospital with primary BPH diagnosis After insertion of a Urinary catheter, are treated with 1mg per kg per day oral Cyproterone acetate, combined with 0.4 mg per day Tamsulosin capsule for 4 weeks. Then Tamsulosin treatment is continued for up to 6 months. The urinary catheter is removed a week after insertion.
Category
Treatment - Drugs

2

Description
Control group: Patients who complained of acute urinary retention are referred to the Urology Emergency Department of Quaem Hospital with primary BPH diagnosis After insertion of a Urinary catheter, are treated with 0.4 mg per day Tamsulosin capsules for 6 months. The urinary catheter is removed a week after insertion.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Quaem hospital
Full name of responsible person
Amin Korooji
Street address
Ahmad-abad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3843 2424
Email
Quaem.Medical.Center@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahyar Mirheydari
Street address
Opposite of 18 Ave, Daneshgah Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3845 3456
Email
Mirheydarim1@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 Korooji
Position
Medical urology assistant
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
No. 30 ,18th Ave , Fakoori Blvd , Abo-barq Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9178115137
Phone
+98 51 3868 9405
Fax
Email
karojia941@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amin Korooji
Position
Medical urology assistant
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
No. 30 ,18th Ave , Fakoori Blvd , Abo-barq Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9178115137
Phone
+98 51 3868 9405
Fax
Email
karojia941@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amin Korooji
Position
Medical urology assistant
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
No. 30 ,18th Ave , Fakoori Blvd , Abo-barq Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9178115137
Phone
+98 51 3868 9405
Fax
Email
karojia941@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
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...