To assess the effect of Botulinum A toxin versus anticholinergic on clinical symptoms of patients with overactive bladder
Design
This is a Phase III randomized clinical trial with a control group, in which eligible patients will be randomly assigned to the intervention and control groups using block randomization.
Settings and conduct
This study will be conducted at the Beheshti Hospital in Hamadan city, involving 42 eligible patients with overactive bladder. The patients will be randomly assigned to the intervention and control groups through the block randomization. However, it should be noted that blinding is not feasible in this trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 80 years
Overactive bladder
Exclusion criteria:
Pregnancy or breastfeeding
Neuromuscular diseases
Taking anticoagulants
Allergy to egg white
Intervention groups
Intervention group:
Injection of 100 to 300 units of Botulinum A toxin in 20 to 30 points of the bladder wall with the help of a cystoscope under spinal anesthesia plus one gram of intravenous cephalin antibiotic
Control group:
Anticholinergic drugs include Urinacin 10 mg daily plus oxybutynin 5 mg every 12 hours for 3 month.
Main outcome variables
Primary outcome:
Severity of clinical symptoms (frequency, urgency, nocturia)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N488
Registration date:2023-11-01, 1402/08/10
Registration timing:prospective
Last update:2023-11-01, 1402/08/10
Update count:0
Registration date
2023-11-01, 1402/08/10
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Botulinum A toxin versus anticholinergic on clinical symptoms of patients with overactive bladder: a randomized clinical trial
Public title
Effect of Botulinum A toxin versus anticholinergic on clinical symptoms of patients with overactive bladder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 80 years
Overactive bladder
Exclusion criteria:
Pregnancy or breastfeeding
Neuromuscular diseases
Taking anticoagulants
Allergy to egg white
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, random assignment of patients to the intervention and control groups will be carried out using block randomization. To achieve this, four sheets of paper will be prepared - two with the name of the intervention and two with the name of the control. These paper sheets will be pooled and placed in a container. Patients will be selected one at a time without replacement, and for each patient, a paper sheet will be randomly drawn from the container. After each draw, the paper sheets will be returned to the container, and the process will be repeated until the desired sample size is reached.
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2023-10-28, 1402/08/06
Ethics committee reference number
IR.UMSHA.REC.1402.495
Health conditions studied
1
Description of health condition studied
Overactive bladder
ICD-10 code
N32.81
ICD-10 code description
Overactive bladder
Primary outcomes
1
Description
Severity of clinical symptoms (frequency, urgency, nocturia)
Timepoint
Before the intervention and 3 months later
Method of measurement
Using International Incontinence Consultation Questionnaire (ICIQ)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Injection of 100 to 300 units of Botulinum A toxin in 20 to 30 points of the bladder wall with the help of a cystoscope under spinal anesthesia plus one gram of intravenous cephalin antibiotic
Category
Treatment - Drugs
2
Description
Control group: Anticholinergic drugs include Urinacin 10 mg daily plus oxybutynin 5 mg every 12 hours for 3 month.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti Hospital in Hamadan city
Full name of responsible person
Narges Ahmadvan
Street address
Beheshti Hospital, Eram Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0283
Email
nargesahmadvand72@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Narges Ahmadvand
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
nargesahmadvand72@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Behzad Mohammad Soori
Position
Urologist
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
School of Medicine, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
drbehzadsoori@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.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