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临床试验/NCT04628351
NCT04628351已完成不适用

The Effect of Structured Bladder Training Program on Lower Urinary System Symptoms and Quality of Life After Radical Prostatectomy

Saglik Bilimleri Universitesi1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年10月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Urinary incontinence-related quality of life assessed by the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)

研究概览

简要总结

Radical prostatectomy is the gold standard in the treatment of patients with localized prostate cancer. Urinary incontinence, which is common after surgery, can affect the quality of life of men negatively. There are various attempts to prevent and treat urinary symptoms after radical prostatectomy.The aim of this study is to evaluate the effect of the structured bladder training program on lower urinary tract symptoms and quality of life in patients undergoing radical prostatectomy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
40 Years 至 85 Years(Adult, Older Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •Being over the age of 40 years
  • •Being male
  • •Being with localized prostate cancer
  • •Undergoing open radical prostatectomy
  • •No preoperative urinary incontinence
  • •Being body mass index> 30 kg/m2
  • •Agreeing to participate in the research
  • •Being literate

排除标准

  • •Having a congenital disorder of the urinary system
  • •Having neurological disorders
  • •Having a history of transurethral resection of the prostate
  • •Having communication and mental impairment
  • •Inability to do pelvic floor muscle exercises

研究组 & 干预措施

Bladder Training

Experimental

Patients in the structured bladder training group were trained on "lifestyle changes (nutrition, fluid management, exercise), pelvic floor muscle exercises and bladder control techniques".

干预措施: Bladder Training (Behavioral)

Control Group

No Intervention

Routine patient training was given to the patients in the control group by a nurse working in the clinic.

结局指标

主要结局

Urinary incontinence-related quality of life assessed by the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)

时间窗: 3 months after from baseline (0 month)

The primary endpoint of this study was the difference between groups in terms of International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) scores 3 months after. This scale consists of 6 questions.The range of scores obtained from the scale varies between 0-21 points. High scores on the scale indicate that the quality of urinary incontinence is severely affected.

次要结局

  • Lower urinary tract symptoms assessed by the International Consultation on Incontinence Questionnaire-Male Lower Urinary Tract Symptoms (ICIQ-MLUTS)(3 months after from baseline (0 month))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elif Gezginci

RN, PHD, Asst Prof

Saglik Bilimleri Universitesi

研究点 (1)

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