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Clinical Trials/NCT03695692
NCT03695692
Unknown
Not Applicable

Assistant Professor, Physioterapist, PhD

Seyda TOPRAK CELENAY1 site in 1 country40 target enrollmentMay 2, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Overactive Bladder
Sponsor
Seyda TOPRAK CELENAY
Enrollment
40
Locations
1
Primary Endpoint
overactive bladder symptoms measured by Overactive Bladder Questionnaire_V8
Last Updated
7 years ago

Overview

Brief Summary

The aim of this study was to compare the effects of pelvic floor muscle trainig with connective tissue massage and only pelvic floor muscle training in women with overactive bladder

Registry
clinicaltrials.gov
Start Date
May 2, 2018
End Date
October 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Factorial
Sex
Female

Investigators

Sponsor
Seyda TOPRAK CELENAY
Responsible Party
Sponsor Investigator
Principal Investigator

Seyda TOPRAK CELENAY

Assistant Professor

Ataturk Training and Research Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • being in the period of pregnancy or breastfeeding,
  • having an accompanying neurological disease, presence of a mental issue that would prevent cooperation in examinations and/or implementations, history of acute infectionor presence of a malignce

Outcomes

Primary Outcomes

overactive bladder symptoms measured by Overactive Bladder Questionnaire_V8

Time Frame: 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. The final score is the sum of the partial scores obtained for each of the eight questions, ranging from 0 to 40. Patients with a final score of eight or more are considered as having Overactive Bladder symptoms.

Secondary Outcomes

  • pelvic floor muscle strength measured with perineometer(Change from baseline pelvic floor muscle strength at 6 weeks)
  • diurnal urinary frequency, nocturia, maximum urinary volume, the number of urinary leakage and pad changes measured with voiding dairy(Change from baseline diurnal urinary frequency, nocturia, maximum urinary volume, the number of urinary leakage and pad changes at 6 weeks)
  • urgency complaint assessed with The patient's Perception of Intensity of Urgency Scale(Change from baseline urgency complaints at 6 weeks)
  • quality of life assessed with King's Health Questionnaire (KHQ)(Change from baseline quality of life at 6 weeks)

Study Sites (1)

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