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Comparison the efficacy of prescription Anticholinergic alone and with Diazepam in treatment of pain related to bladder spasm in post operation of open prostatectomy

Protocol summary

Study aim
Comparison the efficacy of prescription Anticholinergic alone and combination with Diazepam in treatment of pain related to bladder spasm in post operation of open prostatectomy
Design
Two arm parallel group ,non randomised , a blinded with control group clinical trial.
Settings and conduct
According to sever pain arising from ladder Spasm after open prostatectomy , in order to better method for decrease pain and based on done studies , designed a study that include 2 groups of 20 patients with Bladder Spasm after open prostatectomy in Shohadaye Khalij Fars Hospital of Bushehr . to one group given Tolterodine ta 2mg every 12 hours and second group recived Tolterodine tab 2mg every 12 hours and Diazepam tab 5mg every night ; then patients of 2 groups assessed and compared based on received Methadone amp 5mg and pain severity before , 6hrs , 12hrs , 18 hrs , 24hrs , 36hrs and 48hrs after the giving the drugs .
Participants/Inclusion and exclusion criteria
all patients with bladder spasm after open prostatectomy enter to study and patients that use anti depressent and narcotic drugs and opiums , patients that have oerate under generalize anesthesia , patients with sever ischemic diseases and patient that have contraandication for Tolterodine and Diazepam , exit from study.
Intervention groups
first group received Tolterodine tab every 12 hrs and secound group received Tolterodine tab every 12 hrs and Diazepam tab 5mg every nighte and , both groups received Methadon ampul 5mg if pain score ( according NRS) be upper than 4 .
Main outcome variables
effect of diazepam on bladder spasm pain , effect of Tolterodine on Bladder Spasm pain , Access to effective analgesic cpmbination therapy , more effective decreased of patients's pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190127042515N1
Registration date: 2019-02-11, 1397/11/22
Registration timing: prospective

Last update: 2019-02-11, 1397/11/22
Update count: 0
Registration date
2019-02-11, 1397/11/22
Registrant information
Name
fatemeh dehghani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3332 2081
Email address
fa.dehghani.94@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the efficacy of prescription Anticholinergic alone and with Diazepam in treatment of pain related to bladder spasm in post operation of open prostatectomy
Public title
Effect of Diazepam in treatment of bladder spasm
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All of patient with bladdre spasm after open prostatectomy
Exclusion criteria:
Opium and anti depressent and narcotic drug user General anesthesia Oversensivity to Tolterodine and Diazepam Unstable hemodynamic state Severe ischemic heart diseases
Age
No age limit
Gender
Male
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Only urologist prescibe the drugs and valuator , patient and analisor don`t know about prescripted drug . only one valuator relation with patients directly
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Bushehr University of Medical Science
Street address
Sabzabad Ave , Salman Farsi Ave, Bushehr University of Medical Science
City
Bushehr
Province
Boushehr
Postal code
7518759577
Approval date
2018-10-09, 1397/07/17
Ethics committee reference number
IR.BPUMS.REC.1397.057

Health conditions studied

1

Description of health condition studied
bladder spasm
ICD-10 code
N32.89
ICD-10 code description
Other specified disorders of bladder

Primary outcomes

1

Description
Pain scor according to Numerical Rating Scale
Timepoint
Befor intervention , 6 , 12 , 18 , 24 , 36 and 48 hours after intervention
Method of measurement
Nimerical Ratig Pain Scale

2

Description
Recieved methadone amounts
Timepoint
During 48 hours after prescriptin of drugs
Method of measurement
Methadon ampuls amount

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Tolterodine tab 2mg N =1 every 12 hrs for 48hrs
Category
Treatment - Drugs

2

Description
Intervention group: Tolterodine tab 2mg N =1 every 12 hrs for 48hrs and Diazepam tab 5mg N=1 nightly
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohadaye Khalij Fars Hospital
Full name of responsible person
Mohammad Zaki Abbasi
Street address
Ayatollah Taleghani St, Shohadaye Khalij Fars Hospital
City
Bushehr
Province
Boushehr
Postal code
7517933755
Phone
+98 77 3345 5375
Fax
Email
MPGH@BPUMS.AC.IR
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Dr. Afshin Ostovar
Street address
Sabzabad Ave , Salman Farsi Ave, Bushehr University of Medical Science
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 0178
Fax
+98 77 3345 2228
Email
Pkarshenasan@Yahoo.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Boushehr 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
Boushehr University of Medical Sciences
Full name of responsible person
Mohammad Zaki Abbasi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Bushehr University of Medical science , Salman Farsi Ave, Sabzabad Blv , Bahmani
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 0236
Email
Dr_mz_abbasi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Mohammad Zaki Abbasi
Position
Assistavt Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Bushehr University of Medical science , Salman Farsi Ave, Sabzabad Blv , Bahmani
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 0236
Email
Dr_mz_abbasi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Fatemeh Dehghani
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Bushehr University of Medical science , Salman Farsi Ave, Sabzabad Blv , Bahmani
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 0236
Email
fa.dehghani.94@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
اطلاعات بیشتری وجود ندارد
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All of data are publishable
When the data will become available and for how long
One year after publish the results
To whom data/document is available
All of person
Under which criteria data/document could be used
Request of access to data and documents are acceptable if the purpose is education and treatment.
From where data/document is obtainable
Requests are given to Bushehr University of Medical Science Vice President of Research and Email of Fatemeh Dehghani or Mohammad Zaki Abbasi.
What processes are involved for a request to access data/document
raised the question will be answered at less than 5 days
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