跳至主要内容
临床试验/NCT02510131
NCT02510131Unknown不适用

Is Hyacinth Exercise Better Than Kegel's Exercise in Women With Urinary Incontinence?

University of Malaya2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2015年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
180
试验地点
2
主要终点
Female pelvic floor questionnaires scoring

研究概览

简要总结

To determine whether Hyacinth exercises are more effective than Kegel's exercise at improving pelvic floor weakness among women aged 55 and above with urinary incontinence.

详细描述

Individuals who admit to have urinary leakage will be examined to determine the nature of their problem and individuals for whom Kegel exercises are likely to be for benefit will be recruited into this study.

One hundred and eighty women who participants who agree to be randomized to Kegel's or Hyacinth exercises will be randomized.

The treatment allocation will be sealed opaque enveloped and stored in a secure location.

Participants will be blinded from the treatment arm, and as much as possible, participants in different arms of the study would be given different appointment dates to avoid contamination.

Exercises will be prescribed by a trained personnel, and flexibility is added to the routine to enable tailoring to individual lifestyles and choices.

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
55 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Woman aged above 55 with urinary incontinence.

排除标准

  • Individuals who are unable or unwilling to provide written informed consent.
  • Stage 3 and 4 pelvic organ prolapse.
  • Individuals who have physical weakness and are unable to do kegel plus exercises.
  • Neuropathic injury of pelvic floor muscles.

研究组 & 干预措施

Pelvic floor exercise

Active Comparator

Participants randomized to Kegel's exercises will be asked to contract their pelvic floor muscle for 1-10 seconds, followed by 10 seconds' relaxation.

Length of duration of exercise is tailored to individual's ability in contracting her pelvic floor muscle.

Each cycle is equivalent to 1 contraction and 1 relaxation phase. Participants will be asked to perform 3 sessions per day, and to perform their Kegel exercises at home daily.

1 session of Kegel's exercise is consists of 20 cycles of slow twitch fibre contraction and 30 repetitions of fast twitch fibre for 1 minute.

干预措施: Exercises (Behavioral)

Hyacinth exercise

Experimental

In this arm participants are also taught Kegel's exercises but will be additionally taught extra steps which mirrored Muslim's praying steps.

As well as their Kegel's exercises, participants will be asked to perform the extra steps at least 63 minutes per week.

Participants may choose to perform these at the same time or at a different time from their Kegel's exercises. Participants will be asked to perform 1 cycle (3 minutes and 1 second) for 3 sessions a day for daily.

Each cycle is consists of repetition of 4 positions: standing upright- 90 degree bow- prostration-sitting.

干预措施: Exercises (Behavioral)

结局指标

主要结局

Female pelvic floor questionnaires scoring

时间窗: 6 months

to assess woman's urinary incontinence scoring at 0, 2 and 6 months, to look for improvement from baseline to 6 months after exercises

次要结局

  • intravaginal biofeedback measurements(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验