Back to resultsEffects of Connective Tissue Massage in Women With Overactive Bladder
Primary Purpose
Overactive Bladder
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
pelvic floor exercise and connective tissue massage
pelvic floor exercise
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder
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
Sites / Locations
- Ankara Yildirim Beyazit UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Connective tissue massage group
Control group
Arm Description
Pelvic floor exercises and connective tissue massage have been applied
Pelvic floor exercises alone have been applied
Outcomes
Primary Outcome Measures
overactive bladder symptoms measured by 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. 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 Outcome Measures
urgency complaint assessed with The patient's 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.
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.
pelvic floor muscle strength measured with perineometer
change in pelvic floor muscle strength as measued with perineometer
diurnal urinary frequency, nocturia, maximum urinary volume, the number of urinary leakage and pad changes measured with voiding dairy
Patients will be also instructed to keep voiding diary for three days. In this diary, diurnal urinary frequency, nocturia, maximum urinary volume, the number of urinary leakage and pad changes will be recorded.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03695692
Brief Title
Effects of Connective Tissue Massage in Women With Overactive Bladder
Official Title
Assistant Professor, Physioterapist, PhD
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 2, 2018 (Actual)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
October 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Seyda TOPRAK CELENAY
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Connective tissue massage group
Arm Type
Experimental
Arm Description
Pelvic floor exercises and connective tissue massage have been applied
Arm Title
Control group
Arm Type
Experimental
Arm Description
Pelvic floor exercises alone have been applied
Intervention Type
Behavioral
Intervention Name(s)
pelvic floor exercise and connective tissue massage
Intervention Description
Pelvic floor exercises with connective tissue massage will be performed.The massage program is carried out for 18 sessions, 3 days/week in 6 weeks. The exercise program is performed every day for 6 weeks
Intervention Type
Behavioral
Intervention Name(s)
pelvic floor exercise
Intervention Description
The exercise program is performed every day for 6 weeks
Primary Outcome Measure Information:
Title
overactive bladder symptoms measured by Overactive Bladder Questionnaire_V8
Description
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.
Time Frame
Change from baseline bladder symptoms at 6 weeks
Secondary Outcome Measure Information:
Title
urgency complaint assessed with The patient's Perception of Intensity of Urgency Scale
Description
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.
Time Frame
Change from baseline urgency complaints at 6 weeks
Title
quality of life assessed with King's Health Questionnaire (KHQ)
Description
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.
Time Frame
Change from baseline quality of life at 6 weeks
Title
pelvic floor muscle strength measured with perineometer
Description
change in pelvic floor muscle strength as measued with perineometer
Time Frame
Change from baseline pelvic floor muscle strength at 6 weeks
Title
diurnal urinary frequency, nocturia, maximum urinary volume, the number of urinary leakage and pad changes measured with voiding dairy
Description
Patients will be also instructed to keep voiding diary for three days. In this diary, diurnal urinary frequency, nocturia, maximum urinary volume, the number of urinary leakage and pad changes will be recorded.
Time Frame
Change from baseline diurnal urinary frequency, nocturia, maximum urinary volume, the number of urinary leakage and pad changes at 6 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seyda TOPRAK CELENAY
Phone
+90-534-041-3986
Email
sydtoprak@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yasemin KARAASLAN
Phone
+90 535 845 9625
Email
ptyasemindeveci@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seyda TOPRAK CELENAY
Organizational Affiliation
Ankara Yildirim Beyazıt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yasemin Karaaslan
Organizational Affiliation
Beykent University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Faruk Kucukdurmaz
Organizational Affiliation
Kahramanmaras Sutcu Imam University
Official's Role
Study Chair
Facility Information:
Facility Name
Ankara Yildirim Beyazit University
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasemin KARAASLAN
Phone
+90 535 845 96 25
Email
ptyasemindeveci@gmail.com
First Name & Middle Initial & Last Name & Degree
Faruk Kucukdurmaz
12. IPD Sharing Statement
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Effects of Connective Tissue Massage in Women With Overactive Bladder
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