Effects of Connective Tissue Massage in Women With Overactive Bladder
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|ClinicalTrials.gov Identifier: NCT03695692|
Recruitment Status : Recruiting
First Posted : October 4, 2018
Last Update Posted : October 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Overactive Bladder||Behavioral: pelvic floor exercise and connective tissue massage Behavioral: pelvic floor exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Assistant Professor, Physioterapist, PhD|
|Actual Study Start Date :||May 2, 2018|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||October 2019|
Experimental: Connective tissue massage group
Pelvic floor exercises and connective tissue massage have been applied
Behavioral: pelvic floor exercise and connective tissue massage
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
Experimental: Control group
Pelvic floor exercises alone have been applied
Behavioral: pelvic floor exercise
The exercise program is performed every day for 6 weeks
- 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.
- urgency complaint assessed with The patient's Perception of Intensity of Urgency Scale [ Time Frame: 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.
- quality of life assessed with King's Health Questionnaire (KHQ) [ Time Frame: 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.
- pelvic floor muscle strength measured with perineometer [ Time Frame: Change from baseline pelvic floor muscle strength at 6 weeks ]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 [ Time Frame: Change from baseline diurnal urinary frequency, nocturia, maximum urinary volume, the number of urinary leakage and pad changes at 6 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03695692
|Contact: Seyda TOPRAK CELENAYfirstname.lastname@example.org|
|Contact: Yasemin KARAASLAN||+90 535 845 email@example.com|
|Ankara Yildirim Beyazit University||Recruiting|
|Contact: Yasemin KARAASLAN +90 535 845 96 25 firstname.lastname@example.org|
|Contact: Faruk Kucukdurmaz|
|Principal Investigator:||Seyda TOPRAK CELENAY||Ankara Yildirim Beyazıt University|
|Study Chair:||Yasemin Karaaslan||Beykent University|
|Study Chair:||Faruk Kucukdurmaz||Kahramanmaras Sutcu Imam University|