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Effects of Kinesio Taping Application in Women With Overactive Bladder

Primary Purpose

Overactive Bladder Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Kinesio tape application
Sham tape application
Sponsored by
Ataturk Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder Syndrome

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 20 to 65 years of age,
  • having overactive bladder
  • being volunteer

Exclusion Criteria:

  • 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

Sites / Locations

  • Ankara Gazi Mustafa Kemal HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Kinesio tape group

Control group

Arm Description

Kinesio tape application and pelvic floor exercise have been applied

Sham kinesio tape application and pelvic floor exercise have been applied

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
January 20, 2019
Last Updated
January 24, 2019
Sponsor
Ataturk Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03817203
Brief Title
Effects of Kinesio Taping Application in Women With Overactive Bladder
Official Title
Assistant Professor, Physioterapist, PhD
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 15, 2018 (Actual)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
August 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Kinesio tape group
Arm Type
Experimental
Arm Description
Kinesio tape application and pelvic floor exercise have been applied
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Sham kinesio tape application and pelvic floor exercise have been applied
Intervention Type
Other
Intervention Name(s)
Kinesio tape application
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Sham tape application
Intervention Description
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
Primary Outcome Measure Information:
Title
The severity of overactive bladder symptoms assessed with Overactive Bladder Questionnaire_V8
Description
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.
Time Frame
Change from baseline bladder symptoms at 6 weeks
Secondary Outcome Measure Information:
Title
Urgency complaint assessed with the Perception of Intensity of Urgency Scale
Description
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.
Time Frame
Change from baseline urgency complaints at 6 weeks
Title
Daily urinary frequency measured with voiding diary
Description
Patients will be also instructed to keep voiding diary for three days. In this diary, the average daily urinary frequency will be recorded.
Time Frame
Change from baseline the average daily urinary frequency at 6 weeks
Title
The number of nocturia measured with voiding diary
Description
Patients will be also instructed to keep voiding diary for three days. In this diary, the average number of nocturia will be recorded.
Time Frame
Change from baseline the average number of nocturia at 6 weeks
Title
The number of urinary incontinence measured with voiding diary
Description
Patients will be also instructed to keep voiding diary for three days. In this diary, the average number of urinary incontinence will be recorded.
Time Frame
Change from baseline the average number of urinary incontinence at 6 weeks
Title
pelvic floor muscle strength measured with Modified Oxford Grading scale
Description
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.
Time Frame
Change from baseline pelvic floor muscle strength at 6 weeks
Title
quality of life assessed with King's Health Questionnaire (KHQ)
Description
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.
Time Frame
Change from baseline quality of life at 6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 20 to 65 years of age, having overactive bladder being volunteer Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seyda TOPRAK CELENAY
Phone
+90-534-041-3986
Email
sydtoprak@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zehra KORKUT
Phone
+90-507-614-70-80
Email
zehrakorkut85@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seyda TOPRAK CELENAY
Organizational Affiliation
Ankara Yildirim Beyazıt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zehra Korkut
Organizational Affiliation
KTO Karatay University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kemal Oskay
Organizational Affiliation
Ankara Gazi Mustafa Kemal Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Ankara Gazi Mustafa Kemal Hospital
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zehra Korkut
Phone
+90 507 614 70 80
Email
zehrakorkut85@hotmail.com

12. IPD Sharing Statement

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Effects of Kinesio Taping Application in Women With Overactive Bladder

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