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OpenTrials
Completed

NCT Number: NCT04197466

Comparison of Different Treatments for Overactive Bladder Syndrome

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pelvic Floor Exercise Group

Other

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

Other

Kinesio tape application will be performed by ligament technique to the sacral region.

Electrical Stimulation

Other

External electrical stimulation will be performed in the lying, sitting, stand up positions for 30 minutes

Primary outcomes

  1. Bladder Diary

    Time frame: 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 outcomes

  1. King Health Questionnaire

    Time frame: 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

  2. Pelvic Floor Muscle Strength

    Time frame: 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

  3. Overactive bladder symptoms

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ankara Yildirim Beyazıt University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 13, 2019
Registry last updated
Jan 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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