Effects of Connective Tissue Massage in Women With Overactive Bladder

Study Overview
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Brief Summary
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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

Official Title
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Assistant Professor, Physioterapist, PhD

Conditions
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Overactive Bladder

Intervention / Treatment
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* Behavioral: pelvic floor exercise and connective tissue massage
* Behavioral: pelvic floor exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Connective tissue massage group<br>Pelvic floor exercises and connective tissue massage have been applied | Behavioral: pelvic floor exercise and connective tissue massage<br>* 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<br>|
| Experimental: Control group<br>Pelvic floor exercises alone have been applied | Behavioral: pelvic floor exercise<br>* The exercise program is performed every day for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from baseline bladder symptoms at 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from baseline urgency complaints at 6 weeks | 
| 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 | 
| pelvic floor muscle strength measured with perineometer | change in pelvic floor muscle strength as measued 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 | 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. | Change from baseline diurnal urinary frequency, nocturia, maximum urinary volume, the number of urinary leakage and pad changes at 6 weeks |