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临床试验/NCT02212418
NCT02212418已完成不适用

Effect of an Abdominal Hypopressive Technique Program on Pelvic Floor Muscles and Urinary Incontinence in Women: A Randomized Cross-over Trial

Rafael J. Curbelo0 个研究点目标入组 42 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
42
主要终点
change of pelvic floor tone at 2 months and after 4 months

研究概览

简要总结

Abdominal hypopressive technique (AHT) is a therapy created for the treatment of the pelvic floor dysfunctions in the postpartum. In the last years it has been extended out of such medical context but there is a lack of scientific evidence, and the endurability of the effects of this technique are unknown. The investigator´s aim was to evaluate the effect of a 12 weeks AHT program on 1) the tone of the pelvic floor muscles and 2) on urinary incontinence, in women out of the postpartum phase. In addition the investigators looked for the endurability of its effect.

Methods: The investigators performed a cross-over blinded intervention study of 4 month duration, in which women, stratified by age, were randomly assigned to a sequence of AHT-no AHT or no AHT-AHT. The AHT program consisted of 30 minute sessions, 3 days per week during 2 months. The investigators compared the effect of AHT versus no AHT, and of no AHT after 2 months versus AHT.

The endpoints were the differences in perineal tonometry, and urinary incontinence symptoms, as measured by the ICIQ_SF. Comparisons were tested with student t tests, paired or unpaired as adequate.

研究设计

研究类型
Interventional
干预模型
Crossover
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • no systematic participation in sports or physical activities (≤ 3 sessions per week, ≤ 2 weeks per month)
  • between 20 and 65 years old
  • with availability for three afternoons per week.

排除标准

  • hypertension
  • serious diseases
  • pregnancy
  • postpartum phase up to 2 months after delivery.

结局指标

主要结局

change of pelvic floor tone at 2 months and after 4 months

时间窗: at baseline, after 2 months, and after 4 months

Pelvic floor tone was measured by a tonometer (PhoenixTM USB2, France) in a PelvimètreTM, and results are expressed in g/cm2. A physiotherapist specialist in urogynecology did the measurement. This measure was not available for women in their first three days of menstruation or virgins

次要结局

  • change of urinary incontinence at 2 months and after 4 months(perfomed at baseline, after 2 months, and after 4 months)

研究者

发起方
Rafael J. Curbelo
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Rafael J. Curbelo

PhD

University of Valladolid

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