Effects of Connective Tissue Massage in Women With Overactive Bladder

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Seyda TOPRAK CELENAY，Ataturk Training and Research Hospital

Tracking Information

First Submitted Date ^ICMJE

October 2, 2018

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

May 2, 2018

Estimated Primary Completion Date

April 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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.

Descriptive Information

Brief Title ^ICMJE

Effects of Connective Tissue Massage in Women With Overactive Bladder

Official Title ^ICMJE

Assistant Professor, Physioterapist, PhD

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

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

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
Behavioral: pelvic floor exercise
The exercise program is performed every day for 6 weeks

Study Arms

Experimental: Connective tissue massage group
Pelvic floor exercises and connective tissue massage have been applied
Experimental: Control group
Pelvic floor exercises alone have been applied

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

October 2019

Estimated Primary Completion Date

April 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

Female

Ages

30 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Turkey

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Seyda TOPRAK CELENAY，Ataturk Training and Research Hospital

Study Sponsor ^ICMJE

Seyda TOPRAK CELENAY

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Seyda TOPRAK CELENAY Ankara Yildirim Beyazıt University
Study Chair: Yasemin Karaaslan Beykent University
Study Chair: Faruk Kucukdurmaz Kahramanmaras Sutcu Imam University

PRS Account

Ataturk Training and Research Hospital

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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