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临床试验/NCT03695692
NCT03695692Unknown不适用

Assistant Professor, Physioterapist, PhD

Seyda TOPRAK CELENAY1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年5月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
overactive bladder symptoms measured by Overactive Bladder Questionnaire_V8

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 18 to 65 years of age,
  • having overactive bladder
  • being volunteer

排除标准

  • 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

研究组 & 干预措施

Connective tissue massage group

Experimental

Pelvic floor exercises and connective tissue massage have been applied

干预措施: pelvic floor exercise and connective tissue massage (Behavioral)

Control group

Experimental

Pelvic floor exercises alone have been applied

干预措施: pelvic floor exercise (Behavioral)

结局指标

主要结局

overactive bladder symptoms measured by Overactive Bladder Questionnaire_V8

时间窗: 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.

次要结局

  • pelvic floor muscle strength measured 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(Change from baseline diurnal urinary frequency, nocturia, maximum urinary volume, the number of urinary leakage and pad changes at 6 weeks)
  • urgency complaint assessed with The patient's Perception of Intensity of Urgency Scale(Change from baseline urgency complaints at 6 weeks)
  • quality of life assessed with King's Health Questionnaire (KHQ)(Change from baseline quality of life at 6 weeks)

研究者

发起方
Seyda TOPRAK CELENAY
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Seyda TOPRAK CELENAY

Assistant Professor

Ataturk Training and Research Hospital

研究点 (1)

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