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临床试验/NCT03331081
NCT03331081Unknown不适用

Effects of Bladder Training and Pelvic Floor Muscle Training on the Symptomatology of Overactive Bladder Syndrome - a Randomized Controlled Clinical Trial

Federal University of São Paulo0 个研究点目标入组 45 人开始时间: 2017年11月25日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
45
主要终点
Evaluation of subjective cure

研究概览

简要总结

The question is whether vesical training and TMAP can be used in isolation without treatment of overactive bladder syndrome? ALSO will be evaluated in urinary symptoms, a function of the MAP, a quality of life and a satisfaction of the women with the treatment offered.

详细描述

Bladder training includes as resources the educational program, lifestyle modifications, as a strategy to suppress urgency and as programmed urges to improve the control of urgency and incontinence; increase bladder capacity, and thus prolong the intervals between such as urination; giving the patient a confidence in the bladder control. Already, a justification for the use of TMAP is a contraction of the pelvic floor muscles (MAP) inhibits detrusor contraction, improving the symptoms of detrusor overactivity.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women with IUU and / or IUM with a predominance of urinary urgency, capable of contracting MAPs adequately, and who agree to participate in the study, signing the Informed Consent Form.

排除标准

  • Women with a diagnosis of glaucoma, myasthenia gravis, urinary tract obstruction, neurological and chronic-degenerative diseases, decompensated diabetic patients and patients with complete denervation of the pelvic floor, pregnancy, abnormal genital bleeding, impairment of cognition, inability to fill in the diary voiding, genital dystopias beyond the vaginal introitus and urethral sphincter defect. Patients may not be in use or have used anticholinergics, tricyclic antidepressants or local hormone therapy within the six months prior to the study.

结局指标

主要结局

Evaluation of subjective cure

时间窗: At the end of 3 months of supervised treatment

We consider it "satisfied" when the patient does not want another treatment, and "dissatisfied" when the patient wants another treatment option.

次要结局

  • BMI(At the initial evaluation of the patient before starting the 3 months of treatment)
  • Urinary symptoms(At the initial evaluation of the patient before starting the 3 months of treatment)
  • Pregnancies and deliveries(At the initial evaluation of the patient before starting the 3 months of treatment)
  • Pad test(At the initial evaluation of the patient before starting the 3 months of treatment and the end of 3 months of supervised treatment)
  • V8 questionnaire(At the initial evaluation of the patient before starting the 3 months of treatment and the end of 3 months of supervised treatment)
  • Voiding diary(At the initial evaluation of the patient before starting the 3 months of treatment and the end of 3 months of supervised treatment)
  • Quality of life(At the initial evaluation of the patient before starting the 3 months of treatment and the end of 3 months of supervised treatment)
  • MAP function(At the initial evaluation of the patient before starting the 3 months of treatment and the end of 3 months of supervised treatment)

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Letícia de Azevedo Ferreira

Principal Investigator

Federal University of São Paulo

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