Comparison of Different Treatments for Overactive Bladder Syndrome
Primary Purpose
Overactive Bladder, Overactive Bladder Syndrome, Overactive Detrusor
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pelvic Floor Exercise Group
Kinesio tape
Electrical stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder focused on measuring Pelvic Floor Muscle Exercise, Kinesio taping, Electric Stimulation
Eligibility Criteria
Inclusion Criteria:
- Women
- Being Volunteered to participate
- Diagnosed as overactive bladder
Exclusion Criteria:
- Pregnant women
- Patients with a comorbid neurological disorder
- A mental problem that may prevent cooperation and evaluation
- Acute infection
- Sensory loss
- Malignancy
Sites / Locations
- Ankara Yıldırım Beyazıt Üniversitesi
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Pelvic Floor Exercise Group
Kinesiotape Group
Electrical Stimulation Group
Arm Description
Pelvic floor muscle exercises will be recommended as a home program for 6 weeks every day of the week.
In addition to pelvic floor exercise,kinesio tape application will be performed by ligament technique to the sacral region.
In addition to pelvic floor exercise,electrical stimulation will be performed in the lying, sitting, stand up positions for 30 minutes
Outcomes
Primary Outcome Measures
Bladder Diary
Women will be asked to complete a 24-hour frequency-volume chart (urine diary) to assess bladder symptoms. Each woman will fill the chart for a total of 3 days filled in 3 consecutive days. In these diaries, women will be asked to record the number of their urination during the day, how much urine they produce each time they urinate, their incontinence, the type and amount of drinks. Women will be warned not to change their daily voiding habits and the amount of fluids they consume during filling these charts. The data obtained from these three days will be averaged to determine daily voiding frequency, night voiding frequency, average voiding volume, and daily urinary incontinence.
Secondary Outcome Measures
King Health Questionnaire
The Turkish version of the King Health Questionnaire, which was developed to assess the quality of life of women, consisting of 21 items, was shown to be valid and reliable The survey consists of 3 sections and 9 sub-headings. These subheadings are questions that determine general health perception, incontinence impact, role, physical and social limitations, personal relationships, emotions, sleep / energy and severity measures. In addition, the third section includes 9 questions that question the effect of urinary symptoms. In each subheading, a complex scoring algorithm is used for missing values. Scoring varies between "0" and "100.. Decrease in score indicates an increase in quality of life
Pelvic Floor Muscle Strength
Modified Ashword Scale and perineometer device will be used for the measurement of the pelvic floor muscle strength. Modified Ashword Scale is a 6-point scale: 0=no contraction, 1=flicker, 2=weak, 3=moderate, 4=good (with lift), and 5=strong. This measurement scale is incorporated with vaginal palpation in the clinical assessment,.
The PFX perineometer (Cardio Design Pty Ltd, Australia) will be used to provide an objective measurement. In the lithotomy position the probe of the perineometer will be inserted into the vagina of the patient. The patient will be asked to relax and squeeze the probe of the perineometer as if they are holding the urine or gaita. The minimum and maximum value of the perineometer are between 0-12 kg Pascal (kPa) and the difference between the first value and the last value in the perineometer will be determined as the pelvic floor muscle strength. The average of three repetitions will be noted
Overactive bladder symptoms
Symptoms will be assessed by the Turkish version of the Overactive Bladder-V8 (OAB-V8) questionnaire, which has been shown to be valid and reliable. The AAM-V8 questionnaire had 8 questions scored as 0 to 5. The total score ranges from 0 to 40. Increased scores indicate that the severity of overactive bladder complaints increases.
Full Information
NCT ID
NCT04197466
First Posted
December 11, 2019
Last Updated
January 23, 2021
Sponsor
Ankara Yildirim Beyazıt University
1. Study Identification
Unique Protocol Identification Number
NCT04197466
Brief Title
Comparison of Different Treatments for Overactive Bladder Syndrome
Official Title
Comparison of Different Treatments for Overactive Bladder Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
December 6, 2019 (Actual)
Primary Completion Date
April 7, 2020 (Actual)
Study Completion Date
April 7, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ankara Yildirim Beyazıt University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study aims to investigate the effects of pelvic floor muscle exercises, electrical stimulation and taping in patients with overactive bladder
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder, Overactive Bladder Syndrome, Overactive Detrusor
Keywords
Pelvic Floor Muscle Exercise, Kinesio taping, Electric Stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pelvic Floor Exercise Group
Arm Type
Experimental
Arm Description
Pelvic floor muscle exercises will be recommended as a home program for 6 weeks every day of the week.
Arm Title
Kinesiotape Group
Arm Type
Experimental
Arm Description
In addition to pelvic floor exercise,kinesio tape application will be performed by ligament technique to the sacral region.
Arm Title
Electrical Stimulation Group
Arm Type
Experimental
Arm Description
In addition to pelvic floor exercise,electrical stimulation will be performed in the lying, sitting, stand up positions for 30 minutes
Intervention Type
Other
Intervention Name(s)
Pelvic Floor Exercise Group
Intervention Description
The exercise program will be tailored according to the pelvic floor muscle strength, including fast and slow contractions. The number and duration of exercises will be increased according to progress..
Intervention Type
Other
Intervention Name(s)
Kinesio tape
Intervention Description
Kinesio tape application will be performed by ligament technique to the sacral region.
Intervention Type
Other
Intervention Name(s)
Electrical stimulation
Intervention Description
External electrical stimulation will be performed in the lying, sitting, stand up positions for 30 minutes
Primary Outcome Measure Information:
Title
Bladder Diary
Description
Women will be asked to complete a 24-hour frequency-volume chart (urine diary) to assess bladder symptoms. Each woman will fill the chart for a total of 3 days filled in 3 consecutive days. In these diaries, women will be asked to record the number of their urination during the day, how much urine they produce each time they urinate, their incontinence, the type and amount of drinks. Women will be warned not to change their daily voiding habits and the amount of fluids they consume during filling these charts. The data obtained from these three days will be averaged to determine daily voiding frequency, night voiding frequency, average voiding volume, and daily urinary incontinence.
Time Frame
Before the treatment, at end of 6 weeks
Secondary Outcome Measure Information:
Title
King Health Questionnaire
Description
The Turkish version of the King Health Questionnaire, which was developed to assess the quality of life of women, consisting of 21 items, was shown to be valid and reliable The survey consists of 3 sections and 9 sub-headings. These subheadings are questions that determine general health perception, incontinence impact, role, physical and social limitations, personal relationships, emotions, sleep / energy and severity measures. In addition, the third section includes 9 questions that question the effect of urinary symptoms. In each subheading, a complex scoring algorithm is used for missing values. Scoring varies between "0" and "100.. Decrease in score indicates an increase in quality of life
Time Frame
Before the treatment and end of 6 weeks
Title
Pelvic Floor Muscle Strength
Description
Modified Ashword Scale and perineometer device will be used for the measurement of the pelvic floor muscle strength. Modified Ashword Scale is a 6-point scale: 0=no contraction, 1=flicker, 2=weak, 3=moderate, 4=good (with lift), and 5=strong. This measurement scale is incorporated with vaginal palpation in the clinical assessment,.
The PFX perineometer (Cardio Design Pty Ltd, Australia) will be used to provide an objective measurement. In the lithotomy position the probe of the perineometer will be inserted into the vagina of the patient. The patient will be asked to relax and squeeze the probe of the perineometer as if they are holding the urine or gaita. The minimum and maximum value of the perineometer are between 0-12 kg Pascal (kPa) and the difference between the first value and the last value in the perineometer will be determined as the pelvic floor muscle strength. The average of three repetitions will be noted
Time Frame
Before the treatment and end of 6 weeks
Title
Overactive bladder symptoms
Description
Symptoms will be assessed by the Turkish version of the Overactive Bladder-V8 (OAB-V8) questionnaire, which has been shown to be valid and reliable. The AAM-V8 questionnaire had 8 questions scored as 0 to 5. The total score ranges from 0 to 40. Increased scores indicate that the severity of overactive bladder complaints increases.
Time Frame
Before the treatment, at end of 6 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women
Being Volunteered to participate
Diagnosed as overactive bladder
Exclusion Criteria:
Pregnant women
Patients with a comorbid neurological disorder
A mental problem that may prevent cooperation and evaluation
Acute infection
Sensory loss
Malignancy
Facility Information:
Facility Name
Ankara Yıldırım Beyazıt Üniversitesi
City
Ankara
Country
Turkey
12. IPD Sharing Statement
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Comparison of Different Treatments for Overactive Bladder Syndrome
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