Comparison of Different Treatments for Overactive Bladder Syndrome

Not Applicable

Completed

• Conditions: Overactive Detrusor; Overactive Bladder; Overactive Bladder Syndrome
• Interventions: Other: Pelvic Floor Exercise Group; Other: Kinesio tape; Other: Electrical stimulation

• Registration Number: NCT04197466
• Lead Sponsor: Ankara Yildirim Beyazıt University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-06
• Study First Submitted: 2019-12-11
• Study First Submitted QC: 2019-12-11
• Study First Posted: 2019-12-13
• Primary Completion: 2020-04-07
• Study Completion: 2020-04-07
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-23
• Last Update Posted: 2021-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pelvic Floor Exercise Group	Pelvic Floor Exercise Group	Pelvic floor muscle exercises will be recommended as a home program for 6 weeks every day of the week.
Kinesiotape Group	Pelvic Floor Exercise Group	In addition to pelvic floor exercise,kinesio tape application will be performed by ligament technique to the sacral region.
Electrical Stimulation Group	Pelvic Floor Exercise Group	In addition to pelvic floor exercise,electrical stimulation will be performed in the lying, sitting, stand up positions for 30 minutes
Kinesiotape Group	Kinesio tape	In addition to pelvic floor exercise,kinesio tape application will be performed by ligament technique to the sacral region.
Electrical Stimulation Group	Electrical stimulation	In addition to pelvic floor exercise,electrical stimulation will be performed in the lying, sitting, stand up positions for 30 minutes

Primary Outcome Measures

Name	Time	Method
Bladder Diary	Before the treatment, at end of 6 weeks	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

Name	Time	Method
Pelvic Floor Muscle Strength	Before the treatment and end of 6 weeks	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	Before the treatment, at end of 6 weeks	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.
King Health Questionnaire	Before the treatment and end of 6 weeks	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

Trial Locations

Locations (1)

Ankara Yıldırım Beyazıt Üniversitesi; 🇹🇷 Ankara, Turkey