Effects of Connective Tissue Massage in Women With Overactive Bladder

赞助:

合作者:

信息的提供 (责任方):

Seyda TOPRAK CELENAY，Ataturk Training and Research Hospital

追踪信息

首次提交日期 ^ICMJE

October 2, 2018

首次发布日期e ^ICMJE

October 4, 2018

最后更新发布日期

October 4, 2018

预计研究开始日期 ^ICMJE

May 2, 2018

预计主要完成日期

April 2019 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^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.

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^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.

描述性信息

简略标题 ^ICMJE

Effects of Connective Tissue Massage in Women With Overactive Bladder

正式标题 ^ICMJE

Assistant Professor, Physioterapist, PhD

简要概况

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

详细说明

研究类型 ^ICMJE

Interventional

研究阶段

N/A

研究设计 ^ICMJE

分配: Randomized
干预模型: Factorial Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^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

研究工具

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

招募信息

招募状态 ^ICMJE

Recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

October 2019

预计主要完成日期

April 2019 (主要结果测量的最终数据收集日期)

合格标准 ^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

性别

参与研究的性别:

Female

年龄

最小年龄：30 Years ，最大年龄：65 Years

接受健康的志愿者

没有

可入组国家 ^ICMJE

Turkey

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

Seyda TOPRAK CELENAY，Ataturk Training and Research Hospital

研究赞助商 ^ICMJE

Seyda TOPRAK CELENAY

合作者 ^ICMJE

研究员 ^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 账户

Ataturk Training and Research Hospital

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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