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Comparison of Different Treatments for Overactive Bladder Syndrome

Comparison of Different Treatments for Overactive Bladder Syndrome

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04197466
Enrollment
66
Registered
2019-12-13
Start date
2019-12-06
Completion date
2020-04-07
Last updated
2021-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder, Overactive Bladder Syndrome, Overactive Detrusor

Keywords

Pelvic Floor Muscle Exercise, Kinesio taping, Electric Stimulation

Brief summary

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

Interventions

OTHERPelvic 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..

OTHERKinesio tape

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

OTHERElectrical stimulation

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

Sponsors

Ankara Yildirim Beyazıt University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Bladder DiaryBefore the treatment, at end of 6 weeksWomen 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

MeasureTime frameDescription
King Health QuestionnaireBefore the treatment and end of 6 weeksThe 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 StrengthBefore the treatment and end of 6 weeksModified 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 symptomsBefore the treatment, at end of 6 weeksSymptoms 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026