Overactive BladderNCT04197466
Comparison of Different Treatments for Overactive Bladder Syndrome
A study testing Pelvic Floor Exercise Group, Kinesio tape and Electrical stimulation in people with Overactive Bladder and Overactive Bladder Syndrome, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the effects of pelvic floor muscle exercises, electrical stimulation and taping in patients with overactive bladder Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Overactive Bladder, Overactive Bladder Syndrome, Overactive Detrusor
- What is being tested?
- Pelvic Floor Exercise Group, Kinesio tape and Electrical stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Dec 2019to 7 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women
- Being Volunteered to participate
- Diagnosed as overactive bladder
Who cannot join
- Pregnant women
- Patients with a comorbid neurological disorder
- A mental problem that may prevent cooperation and evaluation
- Acute infection
- Sensory loss
- Malignancy
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to investigate the effects of pelvic floor muscle exercises, electrical stimulation and taping in patients with overactive bladder
- Being tested
- Pelvic Floor Exercise Group, Kinesio tape, Electrical stimulation
- Keywords
- Pelvic Floor Muscle Exercise, Kinesio taping, Electric Stimulation
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Floor Exercise GroupOther
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 tapeOther
Kinesio tape application will be performed by ligament technique to the sacral region.
Electrical stimulationOther
External electrical stimulation will be performed in the lying, sitting, stand up positions for 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| Pelvic Floor Exercise Group | Experimental | Pelvic floor muscle exercises will be recommended as a home program for 6 weeks every day of the week. Receives: Other: Pelvic Floor Exercise Group |
| Kinesiotape Group | Experimental | In addition to pelvic floor exercise,kinesio tape application will be performed by ligament technique to the sacral region. Receives: Other: Pelvic Floor Exercise Group; Other: Kinesio tape |
| Electrical Stimulation Group | Experimental | In addition to pelvic floor exercise,electrical stimulation will be performed in the lying, sitting, stand up positions for 30 minutes Receives: Other: Pelvic Floor Exercise Group; Other: Electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before the treatment, at end of 6 weeks
Secondary outcomes (3)
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
Measured: Before the treatment and end of 6 weeks
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
Measured: Before the treatment and end of 6 weeks
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.
Measured: Before the treatment, at end of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start6 Dec 2019
- Primary completion7 Apr 2020
- Study completion7 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04197466
- Sponsor's protocol ID
- 2018/06/09
- Status last verified
- Jan 2021
- First submitted
- 11 Dec 2019
- Last updated
- 26 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Treatments for Overactive Bladder Syndrome
- ClinicalTrials.gov ID
- NCT04197466
- Acronym / sponsor ID
- 2018/06/09
- Keywords
- Pelvic Floor Muscle Exercise, Kinesio taping, Electric Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 6 Dec 2019 (actual)
- Primary completion
- 7 Apr 2020 (actual)
- Study completion
- 7 Apr 2020 (actual)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the effects of pelvic floor muscle exercises, electrical stimulation and taping in patients with overactive bladder
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pelvic Floor Exercise Group | Experimental | Other: Pelvic Floor Exercise GroupPelvic floor muscle exercises will be recommended as a home program for 6 weeks every day of the week. |
| Kinesiotape Group | Experimental | Other: Pelvic Floor Exercise Group, Other: Kinesio tapeIn addition to pelvic floor exercise,kinesio tape application will be performed by ligament technique to the sacral region. |
| Electrical Stimulation Group | Experimental | Other: Pelvic Floor Exercise Group, Other: Electrical stimulationIn addition to pelvic floor exercise,electrical stimulation will be performed in the lying, sitting, stand up positions for 30 minutes |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women
- Being Volunteered to participate
- Diagnosed as overactive bladder
Key exclusion criteria (6 listed)
- Pregnant women
- Patients with a comorbid neurological disorder
- A mental problem that may prevent cooperation and evaluation
- Acute infection
- Sensory loss
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic Floor Exercise GroupThe 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.. | Other | Electrical Stimulation Group, Kinesiotape Group, Pelvic Floor Exercise Group |
| Kinesio tapeKinesio tape application will be performed by ligament technique to the sacral region. | Other | Kinesiotape Group |
| Electrical stimulationExternal electrical stimulation will be performed in the lying, sitting, stand up positions for 30 minutes | Other | Electrical Stimulation Group |
Primary outcome
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.
3 secondary outcomes
King Health Questionnaire
Time frame: Before the treatment and end of 6 weeks
Pelvic Floor Muscle Strength
Time frame: Before the treatment and end of 6 weeks
Overactive bladder symptoms
Time frame: Before the treatment, at end of 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic Floor Exercise Group, Kinesio tape and Electrical stimulation in people with Overactive Bladder and Overactive Bladder Syndrome, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bladder Diary (time frame: Before the treatment, at end of 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021.