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Evaluation of clinical effects of oral tamsulosin in reducing urinary retention after spine surgery

Protocol summary

Study aim
Evaluation of clinical effects of oral tamsulosin in reducing postoperative urinary retention
Design
This study is a randomized, double-blind clinical trial with a control group. With parallel groups on 80 patients, the random allocation process will becompleted with Random allocation software.
Settings and conduct
First, they are selected by sampling method available to qualified people and having inclusion criteria. In the following, the blocking method will be used for random acquisition. The random allocation process will be completed with Random allocation software. Based on this, 17 blocks 4 are created with this software and samples are assigned to each of the two groups and the study site of Imam Khomeini Hospital in Sari
Participants/Inclusion and exclusion criteria
Age over 18 years, gender, ability to complete informed consent form, acceptance of study schedule and surgery time, and the fact that he / she must remain in hospital for at least 1 night after surgery. Withdrawal conditions: Allergy or contraindication to tamsulosin use, severe hypersensitivity to sulfa drugs, current warfarin use, use of Foley catheter, suprapubic catheter or urostomy, dialysis patients or end-stage renal disease Kidney disease, urine volume less than 200 CC, sitting blood pressure in the upper extremities 100 mm Hg, orthostatic hypotension
Intervention groups
Planned elective patients who are candidates for spinal surgery Intervention group receiving tamsulosin capsule to patients candidate for posterior surgery in the spine to reduce urinary retention and control group receiving placebo to patients candidate for posterior surgery in the spine for comparison with the intervention group
Main outcome variables
Remaining volume of wood

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140915019185N5
Registration date: 2022-02-06, 1400/11/17
Registration timing: retrospective

Last update: 2022-02-06, 1400/11/17
Update count: 0
Registration date
2022-02-06, 1400/11/17
Registrant information
Name
kaveh haddadi
Name of organization / entity
mazandaran university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 1058
Email address
k.haddadi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
2020-12-21, 1399/10/01
Actual recruitment end date
2021-08-23, 1400/06/01
Trial completion date
2021-08-23, 1400/06/01
Scientific title
Evaluation of clinical effects of oral tamsulosin in reducing urinary retention after spine surgery
Public title
Evaluation of clinical effects of oral tamsulosin in reducing urinary retention after spine surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years Male and female Ability to complete the informed consent form to participate in the study Accepting the schedule of participation in the study and the time of surgery and the fact that she must remain in the hospital for at least 1 night after surgery
Exclusion criteria:
Sensitivity or contraindication to the use of tamsulosin Severe hypersensitivity to sulfa drugs Use of the current alpha-blocker (alphazosin, doxazosin, prazosin, terazosin, verapamil, tamsulosin) or oral alpha agonists, or the initiation of any of these drugs during the start of the intervention phase of the study, which will cause the patient to drop out. Take warfarin now Use of a Foley catheter, suprapubic catheter or urostomy Dialysis patients or patients with less than 200 cc of urine per day Predicting the patient's inability to use the drug orally after surgery Lack of conscious consent to participate in the study Patients who use a Foley catheter chronically Patients are expected to be transferred to the ICU after surgery. Patients with a history of severe heart failure or major cardiovascular events in the past 6 months Use beta-blockers, acetylcholinesterase inhibitors, or drugs that interfere with tamsulosin and betanacol.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 80
Actual sample size reached: 80
Randomization (investigator's opinion)
Randomized
Randomization description
The blocking method will be used for random detection. The random allocation process will be completed with Random allocation software. Accordingly, 17 blocks 6 are created with this software and samples are assigned to each of the three groups. It should be noted that in this study, the patient's informed consent form is first recorded in writing. Participants are then randomly assigned to each group. Used to hide random allocation. Patients and researchers will not know any of the group assignments
Blinding (investigator's opinion)
Double blinded
Blinding description
The SNOSE method is used to hide (blind) random allocation. This method is one of the common methods in concealing random allocation. In this method, first a random sequence is created using Random Allocation software, then based on the sample size of the study, a number of envelopes with aluminum wrappers (in order not to clarify the contents of the envelopes) are prepared and each random sequence is created ( The intervention group (control group) is recorded on a card and the cards are placed in the envelopes of the letter, respectively. In order to maintain a random sequence, naming on the outer surface of the envelopes is done in the same way as it was produced with the software (for example: TF8G is written on the envelope and the card inside the intervention envelope). Finally, the lids of the envelopes are glued and placed in a box, respectively. At the beginning of the registration of participants, according to the order of entry of eligible participants to the study, one of the envelopes of the letter is opened and the assigned group of the participant is revealed.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences, Imam Khomeini Hospital, Sari
Street address
Imam Khomeini Hospital, Razi Street Ethics Committee
City
Sari
Province
Mazandaran
Postal code
33131 - 48166
Approval date
2020-11-25, 1399/09/05
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1399.084

Health conditions studied

1

Description of health condition studied
Urinary retention
ICD-10 code
N32.0
ICD-10 code description
Bladder-neck obstruction

Primary outcomes

1

Description
Urinary retention rate
Timepoint
7 days before surgery and 0 to 2 days after surgery
Method of measurement
sonography

Secondary outcomes

empty

Intervention groups

1

Description
Tamsulosin capsule 4 mg mg daily dose started 7 days before surgery and will continue from zero to 2 days after surgery. The type of oral capsule will be provided to the patient. Urinary retention is prescribed
Category
Treatment - Drugs

2

Description
Placebo capsules 4 /. Mg, which was produced in the Drug Research Center of Mazandaran University of Medical Sciences in a similar way to tamsulosin capsules, started one day 7 days before surgery and will continue from zero to 2 days after surgery. Urinary retention was prescribed.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Kaveh Haddadi
Street address
Amir Mazandarani Blvd. Imam Khomeini Hospital, Neurosurgery Department,
City
Sari
Province
Mazandaran
Postal code
48166-33131
Phone
+98 11 3336 1630
Fax
+98 11 3336 1630
Email
k.haddadi@mazums.ac.ir
Web page address
https://www.mazums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saedi
Street address
Moalem Ave
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3325 7230
Fax
+98 11 3325 7230
Email
m.saedi@mazums.ac.ir
Web page address
https://www.mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Kaveh Haddadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Amir Mazandarani Ave
City
Sari
Province
Mazandaran
Postal code
48166-33131
Phone
+98 11 3336 1630
Fax
+98 11 3336 1630
Email
k.haddadi@mazums.ac.ir
Web page address
https://www.mazums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Kaveh Haddadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Amir Mazandarani Ave
City
Sari
Province
Mazandaran
Postal code
48166-33131
Phone
+98 11 3336 1630
Fax
+98 11 3336 1630
Email
k.haddadi@mazums.ac.ir
Web page address
https://www.mazums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Kaveh Haddadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Amir Mazandarani Ave
City
Sari
Province
Mazandaran
Postal code
48166-33131
Phone
+98 11 3336 1630
Fax
+98 11 3336 1630
Email
k.haddadi@mazums.ac.ir
Web page address
https://www.mazums.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
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