Effects of Kinesio Taping Application in Women With Overactive Bladder

Sponsor
Ataturk Training and Research Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03817203
Collaborator
(none)
40
1
2
8.5
4.7

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Kinesio tape application
  • Other: Sham tape application
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Assistant Professor, Physioterapist, PhD
Actual Study Start Date :
Nov 15, 2018
Anticipated Primary Completion Date :
Jun 1, 2019
Anticipated Study Completion Date :
Aug 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. The severity of overactive bladder symptoms assessed with Overactive Bladder Questionnaire_V8 [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.

Secondary Outcome Measures

  1. Urgency complaint assessed with the Perception of Intensity of Urgency Scale [Change from baseline urgency complaints at 6 weeks]

    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.

  2. Daily urinary frequency measured with voiding diary [Change from baseline the average daily urinary frequency at 6 weeks]

    Patients will be also instructed to keep voiding diary for three days. In this diary, the average daily urinary frequency will be recorded.

  3. The number of nocturia measured with voiding diary [Change from baseline the average number of nocturia at 6 weeks]

    Patients will be also instructed to keep voiding diary for three days. In this diary, the average number of nocturia will be recorded.

  4. The number of urinary incontinence measured with voiding diary [Change from baseline the average number of urinary incontinence at 6 weeks]

    Patients will be also instructed to keep voiding diary for three days. In this diary, the average number of urinary incontinence will be recorded.

  5. pelvic floor muscle strength measured with Modified Oxford Grading scale [Change from baseline pelvic floor muscle strength at 6 weeks]

    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.

  6. quality of life assessed with King's Health Questionnaire (KHQ) [Change from baseline quality of life at 6 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ankara Gazi Mustafa Kemal Hospital Ankara Turkey

Sponsors and Collaborators

  • Ataturk Training and Research Hospital

Investigators

  • Principal Investigator: Seyda TOPRAK CELENAY, Ankara Yildirim Beyazıt University
  • Study Chair: Zehra Korkut, KTO Karatay University
  • Study Chair: Kemal Oskay, Ankara Gazi Mustafa Kemal Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Seyda TOPRAK CELENAY, Assistant Professor, Ataturk Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT03817203
Other Study ID Numbers:
  • 2018/08/05
First Posted:
Jan 25, 2019
Last Update Posted:
Jan 25, 2019
Last Verified:
Jan 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 25, 2019