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临床试验/NCT03727945
NCT03727945已完成不适用

Posture Correction in Abdominopelvic Training in Women With Stress Urinary Incontinence

University of Valencia0 个研究点目标入组 49 人开始时间: 2014年9月最近更新:
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
49
主要终点
Changes from IU impact. KHQ

研究概览

简要总结

Measure effect of postural correction in abdominopelvic exercises on the improvement of the quality of life in patients with SUI. 42 women aged between 46-75 with SUI and stress-predominant mixed urinary incontinence. There were randomly assigned two groups of different treatment.

Quality of life was measured by questionnaires: Incontinence Questionnaire Short Form (ICIQ-IU-SF) and King's Health Questionnaire (KHQ) global punctuation and incontinence impact. Treatment satisfaction was measured by VAS scale.

详细描述

The aim of this study was compare the effect of postural correction in abdominopelvic exercises on the improvement of the quality of life in patients with stress urinary incontinence (SUI).

Was a randomized 2-treatment parallel design study. The sample consist in 42 women aged between 46-75 with stress urinary incontinence (SUI) and stress-predominant mixed urinary incontinence (IUM). They were randomly assigned to two groups: Group 1 (n=21) who received abdomino-pelvic training, and Group 2(n=21) who received the above treatment, guidelines about postural correction.

Both groups received 12 treatment sessions in first session information regarding clinical and demographical aspects will be collected.

To evaluate results of postural correction combined with abdominopelvic exercise women was assessed:at initial session, post- intervention and 3 months post-intervention treatment.Quality of life was measured by spanish validation questionnaires: International Continence Questionnaire Short Form (ICIQ-IU-SF) and King's Health Questionnaire (KHQ) global punctuation and incontinence impact. Treatment satisfaction was measured by Visual analogic scale (VAS).

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)

盲法说明

Urolog was not involved in physiotherapy treatment, randomised patients previous of treatment.

入排标准

年龄范围
45 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • SUI or stress-predominant mixed UI
  • diagnosed via clinical assessment and urodynamic study
  • Estrogenic deficit.: perimenopause, menopause, postmenopause

排除标准

  • grade 3-4 prolapse,
  • functional alterations (Barthel Scale > 85 points),
  • neurological or cognitive alterations (mini mental examination > 24 points)
  • other predominant type of urinary incontinence.

研究组 & 干预措施

abdominopelvic exercise and posture

Experimental

N=21 received supervised physiotherapy abdominopelvic exercise previous postural correction.

干预措施: abdominopelvic exercise and posture (Other)

abdominopelvic exercise

Experimental

N=21 received supervised physiotherapy abdominopelvic exercise.

干预措施: abdominopelvic exercise (Other)

结局指标

主要结局

Changes from IU impact. KHQ

时间窗: baseline,3 months, 6 months

Question nº2 of KHQ measured IU impact in patient's life. Is a Likert scale 0-4 punctuation ( 0= no proceed, 4= A lot)

Changes from IU impact.ICIQ-IU-SF

时间窗: Initial,3 months, 6 months

Question nº3 of ICIQ-IU-SF, measured IU impact in patient's life.Is a numeric scale (1-10),(1= none and 10= a lot )

Changes from Quality of life. KHQ

时间窗: baseline,3 months,6 months

The questionnaire KHQ consists of 30 items distributed in 9 dimensions that we expose below, the scores of this questionnaire vary from 0 to 100, each item presents a scale type Likert with four options of response. The score of the KHQ questionnaire can be globally with a range of 0 (which indicates better health-related quality of life) at 100 points (indicating a worse quality of life)

Treatment satisfaction

时间窗: 3 months

Visual analogic scale (VAS, 0-10, 0=minimum score, 10=maximum score). Higher values represent a better outcome (less treatment satisfaction)

Changes from Quality of life. ICIQ-IU-SF

时间窗: baseline,3 months, 6 months

t consists of four questions that assess the presence of urge urinary incontinence, the amount of fluid evacuated and the involvement of the quality of life. The final score oscillates from 0-21, indicating higher scores to greater severity of the IU.

次要结局

未报告次要终点

研究者

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

Laura Fuentes Aparicio

PhD Professor

University of Valencia

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