NCT03817203

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 25, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

January 25, 2019

Status Verified

January 1, 2019

Enrollment Period

7 months

First QC Date

January 20, 2019

Last Update Submit

January 24, 2019

Conditions

Overactive Bladder Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Urgency complaint assessed with the Perception of Intensity of Urgency Scale

    Change from baseline urgency complaints at 6 weeks

  • Daily urinary frequency measured with voiding diary

    Change from baseline the average daily urinary frequency at 6 weeks

  • The number of nocturia measured with voiding diary

    Change from baseline the average number of nocturia at 6 weeks

  • The number of urinary incontinence measured with voiding diary

    Change from baseline the average number of urinary incontinence at 6 weeks

  • pelvic floor muscle strength measured with Modified Oxford Grading scale

    Change from baseline pelvic floor muscle strength at 6 weeks

  • +1 more secondary outcomes

Study Arms (2)

Kinesio tape group

EXPERIMENTAL

Kinesio tape application and pelvic floor exercise have been applied

Other: Kinesio tape application

Control group

SHAM COMPARATOR

Sham kinesio tape application and pelvic floor exercise have been applied

Other: Sham tape application

Interventions

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

Kinesio tape group
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

Control group

Eligibility Criteria

Age20 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Gazi Mustafa Kemal Hospital

Ankara, Turkey (Türkiye)

RECRUITING

Study Officials

  • Seyda TOPRAK CELENAY

    Ankara Yildirim Beyazıt University

    PRINCIPAL INVESTIGATOR

  • Zehra Korkut

    KTO Karatay University

    STUDY CHAIR

  • Kemal Oskay

    Ankara Gazi Mustafa Kemal Hospital

    STUDY CHAIR

Central Study Contacts

Seyda TOPRAK CELENAY

CONTACT

+90-534-041-3986sydtoprak@hotmail.com

Zehra KORKUT

CONTACT

+90-507-614-70-80zehrakorkut85@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 20, 2019

First Posted

January 25, 2019

Study Start

November 15, 2018

Primary Completion

June 1, 2019

Study Completion

August 1, 2019

Last Updated

January 25, 2019

Record last verified: 2019-01

Locations

TU(1)