Effects of Connective Tissue Massage in Women With Overactive Bladder

Assistant Professor, Physioterapist, PhD

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

Study Overview

• Status: Unknown
• Conditions: Overactive Bladder
• Intervention / Treatment: Behavioral: pelvic floor exercise and connective tissue massage; Behavioral: pelvic floor exercise

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yasemin KARAASLAN; Phone Number: +90 535 845 9625; Email: ptyasemindeveci@gmail.com

Study Locations

• Turkey
  • Ankara, Turkey
    • Recruiting
    • Ankara Yildirim Beyazit University
    • Contact: Yasemin KARAASLAN; Phone Number: +90 535 845 96 25; Email: ptyasemindeveci@gmail.com
    • Contact: Faruk Kucukdurmaz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

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
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
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
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

Collaborators and Investigators

• Sponsor: Seyda TOPRAK CELENAY
• Investigators: Study Chair: Yasemin Karaaslan, Beykent University; Study Chair: Faruk Kucukdurmaz, Kahramanmaras Sutcu Imam University

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2018
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): October 1, 2019

Study Registration Dates

• First Submitted: October 2, 2018
• First Submitted That Met QC Criteria: October 2, 2018
• First Posted (Actual): October 4, 2018

Study Record Updates

• Last Update Posted (Actual): October 4, 2018
• Last Update Submitted That Met QC Criteria: October 2, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive
• Other Study ID Numbers: 2018/07-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No