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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03817203
Other study ID # 2018/08/05
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 15, 2018
Est. completion date August 2019

Study information

Verified date January 2019
Source Ataturk Training and Research Hospital
Contact Seyda TOPRAK CELENAY
Phone +90-534-041-3986
Email sydtoprak@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date August 2019
Est. primary completion date June 2019
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 65 Years
Eligibility 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 Design


Intervention

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 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

Locations

Country Name City State
Turkey Ankara Gazi Mustafa Kemal Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Ataturk Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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