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临床试验/NCT01628991
NCT01628991已完成2 期

Comparison of the Effect of Vaginal Cones and Behavioral Intervention Program on Urinary Stress Incontinence in Women

Mashhad University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2008年4月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
60
试验地点
1
主要终点
severity of Stress Urinary Incontinence

研究概览

简要总结

This study is a single blind randomized clinical trial to compare the efficacy of a behavioral intervention program versus vaginal cones on Stress Urinary Incontinence (SUI).

详细描述

Detailed Description: In this single-blind randomized clinical trial, 60 women aged 25-65 yrs with stress urinary incontinence were randomly divided in two groups by blocked randomization method; behavioral intervention program (n=30) and insertion vaginal device,vaginal cones (n=30). Women in behavioral intervention group were instructed for pelvic floor exercise and bladder control strategies. Other group was allocated to use vaginal cones. They were treated for 12 weeks and followed up every 2 weeks. The subjective changes in severity of SUI were measured using a Detection SUI Severity Questionnaire and leakage index and 3-day urinary dairy. The objective changes were measured by pad test. These two groups were then compared according to the scores of special questionnaires for quality of life, strength of pelvic floor muscles, capability to participate in social activities, severity of urinary incontinence, and the number of involuntary urine passage, taken before, and after 1 and 3 months after finishing interventions. Data analysis will be done through descriptive and perceptive statistical methods by using SPSS.

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 (Participant)

入排标准

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

入选标准

  • •symptoms of SUI , at least three episodes of stress incontinence per week
  • •Age 25-65
  • •body mass index (BMI) ≤ 30 kg/m2
  • •physical health

排除标准

  • •chronic degenerative diseases affected on muscular and nerve tissues
  • •vulvovaginitis, atrophic vaginitis,
  • •pregnancy
  • •active or recurrent urinary tract infections
  • •advanced genital prolepses
  • •patients with cardiac pacemakers

研究组 & 干预措施

behavioural intervention

Experimental

Recieving interventional behavioural program

干预措施: behavioural program (Behavioral)

vaginal cone

Experimental

intravaginal device insertion(vaginal cone)

干预措施: Iranian version of vaginal cones (Device)

结局指标

主要结局

severity of Stress Urinary Incontinence

时间窗: three months

次要结局

  • Quality of life(three months)

研究者

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

nahid golmakani

Faculty member,MSc of Midwifery

Mashhad University of Medical Sciences

研究点 (1)

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