The effects of Botulinum Toxin A on quality of life in women with overactive bladder and urge urinary incontinence in patient In Imam Reza Hospital in Kermanshah city
Design
In this research, 50 women with overactive bladder and urge urinary incontinence referring to Imam Reza Teaching Hospital were chosen purposefully. This study is clinical trial without control group.
Settings and conduct
This study as non-blinded will be done in Imam Reza Hospital in Kermanshah. Patients with urge incontinence and overactive bladder who have failed to respond to anticholinergic treatments or had side effects, 150 units of botulinum toxin A will be injected to 20 bladder dentures.Urinary incontinence and quality of life before treatment and one and six months after the treatment will be investigated.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Aged over 50 years and menopause; Married; Having overactive bladder symptoms three or more during the day; Having urge urinary incontinence; Going to a toilet 8 times or more during the day for 3 days based on the urinary notes.
Exclusion Criteria: Diabetes history; Hypertension, neurological diseases such as multiple sclerosis, myasthenia gravis, and stroke; Urinary incontinence prevalence; Major uterine masses and history of chronic urinary tract infections.
Intervention groups
Patients with urge incontinence and overactive bladder who have failed to respond to anticholinergic treatments or had side effects will be injected with 150 units of Botulinum toxin A at the 20 point of detrusor muscle
Main outcome variables
Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100301003461N10
Registration date:2018-07-06, 1397/04/15
Registration timing:retrospective
Last update:2018-07-06, 1397/04/15
Update count:0
Registration date
2018-07-06, 1397/04/15
Registrant information
Name
Firoozeh Veisi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1823 4276
Email address
f_veisi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah university of medical sciences
Expected recruitment start date
2017-07-19, 1396/04/28
Expected recruitment end date
2018-01-18, 1396/10/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The survey effects of botulinum toxin A on quality of life in women with overactive bladder and urge urinary incontinence
Public title
The survey effects of botulinum toxin A on quality of life in women with overactive bladder and urge urinary incontinence in patient in Imam Reza Hospital in Kermanshah in 2017
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged over 50 years and Menopause
Married
Having overactive bladder symptoms
Those who have not responded to anticholinergicmedications
Have side effects
Have a BMI of between 20-30
Anticholinergic drugs should not be used for 7 days prior of examination and during treatment
Patients should have a residual urine of 100 cc or Less
Mentally and physically capable of intermittent catheterization
urge urinary incontinence
Exclusion criteria:
Diabetes history
Hypertension history
Neurological Diseases such as multiple sclerosis, Myasthenia Gravis and Stroke, Alzheimer's disease, Psychiatric Disorders,
Major Uterine Masses
History of Chronic Urinary Tract Infections
Age
From 50 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic's committee of Kermanshah University of Medical Sciences
Street address
Kermanshah, Shahid Beheshti Blvd, Building No. 2, Research and Technology Dept
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2017-07-19, 1396/04/28
Ethics committee reference number
IR.KUMS.REC.1396.194
Health conditions studied
1
Description of health condition studied
Overactive bladder syndrome
ICD-10 code
n32.8
ICD-10 code description
other specified disorders of bladder
Primary outcomes
1
Description
quality of life in women with overactive bladder and urge urinary incontinence
Timepoint
Before Treatment, One Months After treatment,Six Months After Treatment
Method of measurement
I-QOL Questionnaire to Measure The Effects of Urge Urinary Incontinence on Quality of Life
2
Description
urinary incontinence
Timepoint
Before Treatment, One Months After treatment,Six Months After Treatment
Method of measurement
Ask the patient
Secondary outcomes
1
Description
Urinary Tract Infection
Timepoint
Before treatment, one months after treatment,six months after treatment
Method of measurement
Experiment results
2
Description
Hematuria
Timepoint
Before treatment, one month after treatment, six months after treatment
Method of measurement
Observation and experiment results
3
Description
Dysuria
Timepoint
Before treatment, one month after treatment, six months after treatment
Method of measurement
Ask the Patient
Intervention groups
1
Description
The patient in the operating room will be undergoing cystoscopy by a urologist and assistant women's participation, and toxin botulinum A at 0.5 ccs will be injected with a needle in 20 points of the bladder muscle. (About 150 units) The injection will not be done in the trigone area.