Effects of Connective Tissue Massage in Women With Overactive Bladder

Overactive Bladder Clinical Trial

Official title:

Assistant Professor, Physioterapist, PhD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03695692
• Other study ID #: 2018/07-01
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2018
• Est. completion date: October 2019

Study information

• Verified date: October 2018
• Source: Ataturk Training and Research Hospital
• Contact: Seyda TOPRAK CELENAY
• Phone: +90-534-041-3986
• Email: sydtoprak[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

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

Locations

Country	Name	City	State
Turkey	Ankara Yildirim Beyazit University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Seyda TOPRAK CELENAY

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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