Effects of Connective Tissue Massage in Women With Overactive Bladder

Not Applicable

• Conditions: Overactive Bladder
• Interventions: Behavioral: pelvic floor exercise; Behavioral: pelvic floor exercise and connective tissue massage

• Registration Number: NCT03695692
• Lead Sponsor: Seyda TOPRAK CELENAY

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

Not available

Study Timeline

• Study Start: 2018-05-02
• Status Verified: 2018-10
• Study First Submitted: 2018-10-02
• Study First Submitted QC: 2018-10-02
• Last Update Submitted: 2018-10-02
• Study First Posted: 2018-10-04
• Last Update Posted: 2018-10-04
• Primary Completion: 2019-04
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Control group	pelvic floor exercise	Pelvic floor exercises alone have been applied
Connective tissue massage group	pelvic floor exercise and connective tissue massage	Pelvic floor exercises and connective tissue massage have been applied

Primary Outcome Measures

Name	Time	Method
overactive bladder symptoms measured by Overactive Bladder Questionnaire_V8	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.

Secondary Outcome Measures

Name	Time	Method
pelvic floor muscle strength measured with perineometer	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	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.
urgency complaint assessed with The patient's Perception of Intensity of Urgency Scale	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)	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.

Trial Locations

Locations (1)

Ankara Yildirim Beyazit University; 🇹🇷 Ankara, Turkey