Comparison of the Effect of Vaginal Cones and Behavioral Intervention Program on Urinary Stress Incontinence in Women
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
Recieving interventional behavioural program
干预措施: behavioural program (Behavioral)
vaginal cone
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
nahid golmakani
Faculty member,MSc of Midwifery
Mashhad University of Medical Sciences
