Comparison of Sustained-Released Diclofenac with Placebo on Urethral Dilatation Pain score in two groups called Intervention and Control group, in Urethral Stricture Patients
Effects of Sustained-Released Diclofenac on Urethral Dilatation Pain
Design
Clinical trial with Control group, Parallel groups, single blind, Phase 3, 40 Patients, table of random numbers used for allocation
Settings and conduct
The present study is a single blind randomized clinical trial that was performed on 40 patients referred to the urology clinic of Ghaem Hospital due to urethral stricture from March of 2020 to the end of 2021. Eligible patients were randomly divided into two groups after obtaining informed consent. The intervention group received 100 mg sustained-released Diclofenac tablet 10 hours before urethral dilatation. Patients in the control group received Placebo. Demographic information (age, occupation, etc.), pain during the procedure and 1 hour after the procedure (VAS), the need to take analgesic and side effects were collected in a checklist
Participants/Inclusion and exclusion criteria
Men older than 20 years old, Single stricture and less than 1.5 cm in length
urethral stricture due to Balanitis Xerotica Obliterans
history of hepatic, renal or gastric diseases
patience refusal of participation
History of NSAID Hypersensitivity
Dangerous Diclofenac Side Effects
Intervention groups
Case group received 100 mg of Diclofenac tablet 10 hours before urethral dilatation while Control group received Placebo
Main outcome variables
Pain score during urethral dilatation based on visual analogue scale(VAS), Pain score 1 hour after urethral dilatation based on VAS, the need to take analgesic during the first 24 hours after the procedure, Side effects during the first 24 hours after the procedure.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220711055433N1
Registration date:2022-07-19, 1401/04/28
Registration timing:retrospective
Last update:2022-07-19, 1401/04/28
Update count:0
Registration date
2022-07-19, 1401/04/28
Registrant information
Name
Amir Abbas Asadpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3843 2256
Email address
asadpouraa@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-23, 1399/03/03
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
2020-05-23, 1399/03/03
Actual recruitment end date
2021-06-22, 1400/04/01
Trial completion date
2021-09-22, 1400/06/31
Scientific title
Comparison of Sustained-Released Diclofenac with Placebo on Urethral Dilatation Pain score in two groups called Intervention and Control group, in Urethral Stricture Patients
Public title
Effects of Diclofenac on Urethral stricture treatment pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male gender
Older than 20 years old
Single urethral stricture and stricture length less than 1.5 cm
Exclusion criteria:
Urethral stricture due to Balanitis Xerotica Obliterans
History of hepatic, renal or gastric diseases
Patient refusal of participation
History of NSAID Hypersensitivity
Age
From 20 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients qualified for this clinical trial, were given numbers 01 to 40 considering time of entering the trial. 20 of these numbered patients were allocated to Intervention group using Simple Randomization Method by Fisher and Yates Random Number Table and the other 20 patients were allocated to Control group. So at the time of qualification, the researcher was not aware what each patient's group would be.
Blinding (investigator's opinion)
Single blinded
Blinding description
Each Participant received one envelope containing one Diclofenac tablet or one Placebo tablet similar in color, size, taste and odor to Diclofenac. The envelopes were labeled two different numbers so that researchers knew the content of each envelope and the group each participant was in but the participants themselves were not aware whether they've received Diclofenac or Placebo.
Placebo
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
Ghoreshi Department, Daneshgah St
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2020-01-28, 1398/11/08
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.878
Health conditions studied
1
Description of health condition studied
Urethral Stricture
ICD-10 code
N35
ICD-10 code description
Urethral stricture
Primary outcomes
1
Description
Pain during urethral dilatation
Timepoint
Immediately after urethral dilatation
Method of measurement
Based on Visual Analogue Scale
2
Description
Pain 1 hour after urethral dilatation
Timepoint
1 hour after urethral dilatation
Method of measurement
Based on Visual Analogue Scale
Secondary outcomes
1
Description
The need to take analgesics
Timepoint
24 hours after urethral dilatation
Method of measurement
Yes or No
2
Description
Side effects due to Diclofenac
Timepoint
24 hours after urethral dilatation
Method of measurement
Yes or No
Intervention groups
1
Description
Intervention group: one sustained-release Diclofenac tablet (100mg) Sobhan Darou taken orally 10 hours before urethral dilatation
Category
Treatment - Drugs
2
Description
Control group: one tablet of Placebo similar to Diclofenac tablet in size, taste and color taken orally 10 hours before urethral dilatation
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Amir Abbas Asadpour
Street address
Ghaem Hospital, Ahmadabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0001
Email
b.ghaem@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayor Mobarhan
Street address
Ghoreshi Department, Daneshgah St
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?