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临床试验/NCT03514147
NCT03514147已完成不适用

The Effect of Pelvic Floor Muscle Training on the Quality of Life and Functionality in Women With Urinary Incontinence: a Randomized Controlled Trial

Hospital de Clinicas de Porto Alegre0 个研究点目标入组 56 人开始时间: 2015年10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
56
主要终点
Quality of life in women with urinary incontinence

研究概览

简要总结

Aim: To assess the influence of pelvic floor muscles group training in the quality of life and functionality of these muscles in women with UI.

Study design: This is a randomized controlled trial.

详细描述

Search location: Urogynecology Ambulatory Care of Porto Alegre Clinical Hospital (HCPA)

Patients or participants: Women will be included in aged 35-70 years who have had sexual intercourse in the last 12 months and who are able to understand the instruments, besides signing an informed consent form. Women will be excluded with latex allergy, who have made pelvic radiotherapy, or be undergoing chemotherapy, puerperal a year, or who use antidepressants and / or anxiolytics.

Intervention and measures: The evaluation consists of a medical history form, which will include personal data; the assessment of the MAP function is performed by the pressure biofeedback; for assessment of quality of life will use the questionnaire ICQI-SF and sexual function the PISQ-12 before and after Pelvic Floor Muscle Training.

Expected results: To estimate effectiveness of Pelvic Floor Muscle Training in the quality of life and functionality of these muscles in women with urinary incontinence.

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 (Investigator)

入排标准

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

入选标准

  • Have urinary incontinence;
  • Age between 35 and 70 years;
  • Have sexual intercourse in the last 6 months;
  • Participants should understand the instruments used in the research;
  • Accept to participate in the study and sign the Term of Free and Informed Consent.

排除标准

  • Latex allergy;
  • Have performed or are undergoing pelvic radiotherapy;
  • Be performing chemotherapy treatment;
  • Women who delivered during the last 12 months;
  • Have participated in individual or group MAP training in the last 6 months;
  • Have contraction of the pelvic floor muscles grade zero (0).

研究组 & 干预措施

Experimental

Experimental

Pelvic Floor Muscle Training in group. Exercise Protocol: The exercise group was supervised and met for 1 hour, one time per week, for 12 weeks. Participants were instructed to perform their respective daily exercises.

干预措施: Experimental (Other)

Control

Active Comparator

Pelvic Floor Muscle Training in home Exercise Protocol:The same exercise were performed at home for 12 weeks, without supervision. Participants were instructed to perform their respective daily exercises.

干预措施: Control (Other)

结局指标

主要结局

Quality of life in women with urinary incontinence

时间窗: 12 weeks

International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) - scored between 0 and 21.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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