Overactive Bladder SyndromeNCT03817203
Effects of Kinesio Taping Application in Women With Overactive Bladder
A study testing Kinesio tape application in people with Overactive Bladder Syndrome, run by Ataturk Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the effects of kinesio tape application on bladder symptoms and quality of life in women with overactive bladder (OAB). Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Overactive Bladder Syndrome
- What is being tested?
- Kinesio tape application
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2018to Aug 2019
- 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 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20 to 65 years of age,
- having overactive bladder
- being volunteer
Who cannot join
- pregnancy,
- only stress incontinence,
- the presence of a malignant condition with a history of acute infection,
- having a mental problem to prevent co-morbidity, evaluation and cooperative
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Gazi Mustafa Kemal Hospital
Ankara
Zehra Korkut, +90 507 614 70 80, zehrakorkut85@hotmail.com
About this study
Official title: Assistant Professor, Physioterapist, PhD
The aim of this study is to compare the effects of kinesio tape application on bladder symptoms and quality of life in women with overactive bladder (OAB).
- Conditions
- Overactive Bladder Syndrome
- Being tested
- Kinesio tape application, Sham tape application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio tape applicationOther
Kinesio tape application combined with pelvic floor exercises will be performed.Taping is carried out for 2 days/week in 6 weeks. The exercise program is performed every day for 6 weeks
Sham tape applicationOther
Sham tape application combined with pelvic floor exercises will be performed.Sham taping is carried out for 2 days/week in 6 weeks. The exercise program is performed every day for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Kinesio tape group | Experimental | Kinesio tape application and pelvic floor exercise have been applied Receives: Other: Kinesio tape application |
| Control group | Sham comparator | Sham kinesio tape application and pelvic floor exercise have been applied Receives: Other: Sham tape application |
What is being measured
The primary outcome is the main question the study is designed to answer.
The severity of overactive bladder symptoms assessed with Overactive Bladder Questionnaire_V8
Overactive Bladder Questionnaire_V8 assessing severity of overactive bladder symptoms will be used. This scale includes items on urgency, incontinence, nocturia and voiding frequency, as defined by the International Continence Society, referring to the previous four weeks.
Overactive Bladder Questionnaire_V8 assessing severity of overactive bladder symptoms will be used. This scale includes items on urgency, incontinence, nocturia and voiding frequency, as defined by the International Continence Society. The final score is the sum of the partial scores obtained for each of the eight questions, ranging from 0 to 40.
Measured: Change from baseline bladder symptoms at 6 weeks
Secondary outcomes (6)
Urgency complaint assessed with the Perception of Intensity of Urgency Scale
The patient's Perception of Intensity of Urgency Scale assessing urgency complaints will be used. This scale is scored on 0 and 4 points (the best score is '0' and the worst score is '4') based on urgency complaints. Higher scores indicate more severe urgency complaints.
Measured: Change from baseline urgency complaints at 6 weeks
Daily urinary frequency measured with voiding diary
Patients will be also instructed to keep voiding diary for three days. In this diary, the average daily urinary frequency will be recorded.
Measured: Change from baseline the average daily urinary frequency at 6 weeks
The number of nocturia measured with voiding diary
Patients will be also instructed to keep voiding diary for three days. In this diary, the average number of nocturia will be recorded.
Measured: Change from baseline the average number of nocturia at 6 weeks
The number of urinary incontinence measured with voiding diary
Patients will be also instructed to keep voiding diary for three days. In this diary, the average number of urinary incontinence will be recorded.
Measured: Change from baseline the average number of urinary incontinence at 6 weeks
pelvic floor muscle strength measured with Modified Oxford Grading scale
The modified Oxford Grading Scale quantifies pelvic floor muscle strength as: 0, no contraction; 1, flicker; 2, weak; 3, moderate; 4, good; and 5, strong.
Measured: Change from baseline pelvic floor muscle strength at 6 weeks
quality of life assessed with King's Health Questionnaire (KHQ)
King's Health Questionnaire assessing quality of life related to urinary problems will be used. This questionnaire consists of two parts and 32 items. The first part (21 items) contains two single-item questions that address General Health Perception and Incontinence Impact and the following seven multi-item domains: Role, Physical, and Social Limitations, Limitations in Personal Relationship, Emotional Problems, Sleep and Energy Disturbances associated with UI, and Severity Measures for UI. The second part has an 11-item Symptom Severity Scale (SSS) that assesses the presence and severity of urinary symptoms. While the entire SSS is scored from 0 (best) to 30 (worst), the minimum possible score is 0 (best health) and the maximum possible score is 100 (worst health) for all other KHQ domains.
Measured: Change from baseline quality of life at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start15 Nov 2018
- Primary completionJun 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder SyndromeStudies of the same condition, open and under way.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyda TOPRAK CELENAY, Ataturk Training and Research Hospital
- Investigators
- Seyda TOPRAK CELENAY, Principal investigator, Ankara Yildirim Beyazıt UniversityZehra Korkut, Study chair, KTO Karatay UniversityKemal Oskay, Study chair, Ankara Gazi Mustafa Kemal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03817203
- Sponsor's protocol ID
- 2018/08/05
- Status last verified
- Jan 2019
- First submitted
- 20 Jan 2019
- Last updated
- 25 Jan 2019
- 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 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assistant Professor, Physioterapist, PhD
- ClinicalTrials.gov ID
- NCT03817203
- Acronym / sponsor ID
- 2018/08/05
- Conditions
- Overactive Bladder Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ataturk Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 25 Jan 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.
The aim of this study is to compare the effects of kinesio tape application on bladder symptoms and quality of life in women with overactive bladder (OAB).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinesio tape group | Experimental | Other: Kinesio tape applicationKinesio tape application and pelvic floor exercise have been applied |
| Control group | Sham comparator | Other: Sham tape applicationSham kinesio tape application and pelvic floor exercise have been applied |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 20 to 65 years of age,
- having overactive bladder
- being volunteer
Key exclusion criteria (4 listed)
- pregnancy,
- only stress incontinence,
- the presence of a malignant condition with a history of acute infection,
- having a mental problem to prevent co-morbidity, evaluation and cooperative
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 |
|---|---|---|
| Kinesio tape applicationKinesio tape application combined with pelvic floor exercises will be performed.Taping is carried out for 2 days/week in 6 weeks. The exercise program is performed every day for 6 weeks | Other | Kinesio tape group |
| Sham tape applicationSham tape application combined with pelvic floor exercises will be performed.Sham taping is carried out for 2 days/week in 6 weeks. The exercise program is performed every day for 6 weeks | Other | Control group |
Primary outcome
The severity of overactive bladder symptoms assessed with Overactive Bladder Questionnaire_V8
Time frame: Change from baseline bladder symptoms at 6 weeks
Overactive Bladder Questionnaire_V8 assessing severity of overactive bladder symptoms will be used. This scale includes items on urgency, incontinence, nocturia and voiding frequency, as defined by the International Continence Society, referring to the previous four weeks. Overactive Bladder Questionnaire_V8 assessing severity of overactive bladder symptoms will be used. This scale includes items on urgency, incontinence, nocturia and voiding frequency, as defined by the International Continence Society. The final score is the sum of the partial scores obtained for each of the eight questions, ranging from 0 to 40.
6 secondary outcomes
Urgency complaint assessed with the Perception of Intensity of Urgency Scale
Time frame: Change from baseline urgency complaints at 6 weeks
Daily urinary frequency measured with voiding diary
Time frame: Change from baseline the average daily urinary frequency at 6 weeks
The number of nocturia measured with voiding diary
Time frame: Change from baseline the average number of nocturia at 6 weeks
The number of urinary incontinence measured with voiding diary
Time frame: Change from baseline the average number of urinary incontinence at 6 weeks
pelvic floor muscle strength measured with Modified Oxford Grading scale
Time frame: Change from baseline pelvic floor muscle strength at 6 weeks
quality of life assessed with King's Health Questionnaire (KHQ)
Time frame: Change from baseline quality of life at 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
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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.
Seyda TOPRAK CELENAY principal investigator
Ankara Yildirim Beyazıt University
Zehra Korkut study chair
KTO Karatay University
Kemal Oskay study chair
Ankara Gazi Mustafa Kemal Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio tape application in people with Overactive Bladder Syndrome, run by Ataturk Training and Research Hospital 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 4 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: status not confirmed, as of the sponsor's last update on 25 Jan 2019. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seyda TOPRAK CELENAY (+90-534-041-3986, sydtoprak@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The severity of overactive bladder symptoms assessed with Overactive Bladder Questionnaire_V8 (time frame: Change from baseline bladder symptoms at 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 25 Jan 2019.