Comparison of Different Treatments for Overactive Bladder Syndrome

Overactive Bladder Clinical Trial

Official title:

Comparison of Different Treatments for Overactive Bladder Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04197466
• Other study ID #: 2018/06/09
• Status: Completed
• Phase: N/A
• Start date: December 6, 2019
• Est. completion date: April 7, 2020

Study information

• Verified date: January 2021
• Source: Ankara Yildirim Beyazit University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to investigate the effects of pelvic floor muscle exercises, electrical stimulation and taping in patients with overactive bladder

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: April 7, 2020
• Est. primary completion date: April 7, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Overactive Bladder
• Overactive Bladder Syndrome
• Overactive Detrusor
• Syndrome
• Urinary Bladder, Overactive

Intervention

Other:
• Pelvic Floor Exercise Group
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..
• Kinesio tape
Kinesio tape application will be performed by ligament technique to the sacral region.
• Electrical stimulation
External electrical stimulation will be performed in the lying, sitting, stand up positions for 30 minutes

Locations

Country	Name	City	State
Turkey	Ankara Yildirim Beyazit Üniversitesi	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Yildirim Beyazit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Before the treatment, at end of 6 weeks
Secondary	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	Before the treatment and end of 6 weeks
Secondary	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	Before the treatment and end of 6 weeks
Secondary	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.	Before the treatment, at end of 6 weeks