Effects of Kinesio Taping Application in Women With Overactive Bladder

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).

Study Overview

• Status: Unknown
• Conditions: Overactive Bladder Syndrome
• Intervention / Treatment: Other: Kinesio tape application; Other: Sham tape application

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zehra KORKUT; Phone Number: +90-507-614-70-80; Email: zehrakorkut85@hotmail.com

Study Locations

• Turkey
  • Ankara, Turkey
    • Recruiting
    • Ankara Gazi Mustafa Kemal Hospital
    • Contact: Zehra Korkut; Phone Number: +90 507 614 70 80; Email: zehrakorkut85@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Kinesio tape group; Kinesio tape application and pelvic floor exercise have been applied	Other: Kinesio tape application; 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 Comparator: Control group; Sham kinesio tape application and pelvic floor exercise have been applied	Other: Sham tape application; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from baseline bladder symptoms at 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	Change from baseline quality of life at 6 weeks

Collaborators and Investigators

• Sponsor: Ataturk Training and Research Hospital
• Investigators: Study Chair: Zehra Korkut, KTO Karatay University; Study Chair: Kemal Oskay, Ankara Gazi Mustafa Kemal Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2018
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): August 1, 2019

Study Registration Dates

• First Submitted: January 20, 2019
• First Submitted That Met QC Criteria: January 24, 2019
• First Posted (Actual): January 25, 2019

Study Record Updates

• Last Update Posted (Actual): January 25, 2019
• Last Update Submitted That Met QC Criteria: January 24, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive
• Other Study ID Numbers: 2018/08/05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No