Protocol summary

Study aim
The efficacy of oxybutynin and phenazopyridine and celecoxib and placebo in controlling BCG-induced urinary and systemic symptoms and obtaining the correct protocol for BCG administration is.
Design
In this study, 120 patients with bladder tumor and candidate for treatment of intercostal BCG who were admitted to the Hasheminejad Hospital in Tehran were selected. The participants were randomly divided into four groups of 30, randomly assigned to each group The patients underwent the treatment at the same time during the six weeks of BCG treatment, and weekly signs were recorded in the designed questionnaire and were prepared for statistical analysis.
Settings and conduct
This study is a randomized clinical trial that will be done by parallel groups in four groups. The study population was adult bladder tumor candidate candidate for treatment of Bacillus Calmette–Guérin (BCG) as a 6-week induction protocol that was administered to the Hashemi Nejad Clinic during the year 1395
Participants/Inclusion and exclusion criteria
inclution Criteria of the study are bladder tumor that candidate for Bacillus Calmette–Guérin (BCG) Therapy and aged over 18 years. Exclution criteria include history of pelvic surgery, severe urinary tract symptoms, overactive bladder, complete urinary incontinence, traumatic catheterization , active TB symptoms
Intervention groups
In accordance with the pharmaceutical company, all treatments in the same coating were prepared in a capsule form that were not indistinguishable, and one of the groups was treated with oxybutynin 10 mg daily and the next group of phenazoperidine three times daily and the next group of celecoxib 100 mg and the last group received placebo Within 6 weeks will be tracked
Main outcome variables
dysuria, frequency, urgency

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171225038070N1
Registration date: 2018-07-08, 1397/04/17
Registration timing: retrospective

Last update: 2018-07-08, 1397/04/17
Update count: 0
Registration date
2018-07-08, 1397/04/17
Registrant information
Name
Javad Nikbakht
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8864 4435
Email address
nikbakht.j@kar.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-07-05, 1395/04/15
Expected recruitment end date
2017-11-22, 1396/09/01
Actual recruitment start date
2016-07-05, 1395/04/15
Actual recruitment end date
2017-12-21, 1396/09/30
Trial completion date
empty
Scientific title
Comparison of the efficacy of oxybutynin and phenazopyridine and celecoxib with placebo in the treatment of urinary tract symptoms after BCG therapy in bladder tumors patients
Public title
Assessing the effectiveness of oxybutynin and phenazopyridine and celecoxib in reducing complications in the treatment of bladder tumors.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
bladder cancer candidates for BCG therapy Non muscle bladder cancer
Exclusion criteria:
history of pelvic surgery severe urinary tract symptoms (IPSS over 20) overactive bladder complete urinary incontinence traumatic catheterization active TB symptoms
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: 120
Actual sample size reached: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were divided into four group with random allocation process. The randomized blocks were randomly assigned to the researcher by the design consultant in sealed envelopes. . The creation of a randomized table with the STATA software and its output will be random letters A, B, C, D for treatment groups 1 to 4. After qualifying for inclusion in the study and lack of exclusion criteria by one of the researchers, the envelope designation for the candidate number of the candidate for treatment of BCG is opened and the type of treatment A, B, C, D specified and the person will be treated once a week. And the drug will be delivered to the patient. In co-ordination with the pharmaceutical company, all treatments in the same coatings are provided in capsule form that can not be differentiated
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients were selected according to a randomized table, and the presenter and the investigator were not included in the selected medication. In the case of a person in the study, the medication was placed in the same coat of coat. The designer was blinded to the use of a randomized table and sealed envelopes in which the names of the drugs were used. In the case of the researcher, according to the coding of the participating groups and the naming of groups with blind numbers.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1969714713
Approval date
2016-12-10, 1395/09/20
Ethics committee reference number
IR.IUMS.REC 1395.9311254004

Health conditions studied

1

Description of health condition studied
Malignant neoplasm of bladder
ICD-10 code
C67
ICD-10 code description
Malignant neoplasm of bladder

Primary outcomes

1

Description
frequency
Timepoint
Six consecutive weeks at the same time as the induction treatment period for BCG.The days of 0, 7,14,21,28,35 of the intervention
Method of measurement
Ask the patient and register in the questionnaire

Secondary outcomes

1

Description
urgency
Timepoint
Six consecutive weeks at the same time as the induction treatment period for BCG.The days of 0, 7,14,21,28,35 of the intervention
Method of measurement
Ask the patient and register in the questionnaire

2

Description
Urine painful
Timepoint
Six consecutive weeks at the same time as the induction treatment period for BCG.The days of 0, 7,14,21,28,35 of the intervention
Method of measurement
Ask the patient and register in the questionnaire

3

Description
Fever
Timepoint
Six consecutive weeks at the same time as the induction treatment period for BCG.The days of 0, 7,14,21,28,35 of the intervention
Method of measurement
Thermometer

4

Description
Constipation
Timepoint
Six consecutive weeks at the same time as the induction treatment period for BCG.The days of 0, 7,14,21,28,35 of the intervention
Method of measurement
Ask the patient and register in the questionnaire

5

Description
heart burn
Timepoint
Six consecutive weeks at the same time as the induction treatment period for BCG.The days of 0, 7,14,21,28,35 of the intervention
Method of measurement
Ask the patient and register in the questionnaire

6

Description
Feeling dry mouth
Timepoint
Six consecutive weeks at the same time as the induction treatment period for BCG.The days of 0, 7,14,21,28,35 of the intervention
Method of measurement
Ask the patient and register in the questionnaire

7

Description
Flu-like symptoms
Timepoint
Six consecutive weeks at the same time as the induction treatment period for BCG.The days of 0, 7,14,21,28,35 of the intervention
Method of measurement
Ask the patient and register in the questionnaire

8

Description
arthralgia
Timepoint
Six consecutive weeks at the same time as the induction treatment period for BCG.The days of 0, 7,14,21,28,35 of the intervention
Method of measurement
Ask the patient and register in the questionnaire

Intervention groups

1

Description
Intervention group1: Receive oxybutinine 5 mg every 12 hours for six weeks BCG treatment
Category
Treatment - Drugs

2

Description
Intervention group2: phenazopyridine 100 mg every 8 hours for six weeks BCG treatmentIntervention group:
Category
Treatment - Drugs

3

Description
Intervention group3: Receive celecxibe 100 mg every 12 hours for six weeks BCG treatment
Category
Treatment - Drugs

4

Description
Control group: Receive placebo (Starch-filled capsules) every 12 hours for six weeks of BCG treatment
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Hashemi Nejad Hospital
Full name of responsible person
Javad Nikbakht
Street address
Vali Nejad Ave., Vali Asr St., Vanac Sq.
City
Tehran
Province
Tehran
Postal code
1969714713
Phone
+98 21 8670 5503
Email
javad.nikbakht64@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mehrdad Eftekhar
Street address
Vali Nejad Ave, Vali asr Blvd, Vanac Sq
City
Tehran
Province
Tehran
Postal code
1969714713
Email
javad.nikbakht64@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Javad Nikbakht
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Hashemi Nejad Hospital, Vali Nejad Ave., Vali Asr St.
City
Tehran
Province
Tehran
Postal code
969714713
Phone
+98 21 8864 4435
Email
javad.nikbakht64@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Javad Nikbakht
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Hashemi Nejad Hospital, Vali nejad Ave., Vali Asr St.
City
Tehran
Province
Tehran
Postal code
1969714713
Phone
+98 21 8864 4435
Email
javad.nikbakht64@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Javad Nikbakht
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Hashemi Nejad Hospital, Vali Nejad Ave., Vali asr St.
City
Tehran
Province
Tehran
Postal code
1969714713
Phone
+98 21 8864 4435
Email
javad.nikbakht64@gmail.com

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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