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临床试验/NCT05871281
NCT05871281已完成不适用

Effects of Pelvic Floor Muscle Training and Electrostimulation on Women's Quality of Life and Pelvic Floor Muscle Function in Stress Urinary Incontinence

Lithuanian Sports University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
Quality of life by International Incontinence Counseling Questionnaire - Short Form (ICIQ - SF)

研究概览

简要总结

The goal of this randomized controlled trial is to evaluate and compare the effects of electrostimulation in addition to pelvic floor muscle training and pelvic floor muscle training alone on pelvic floor muscle (PFM) function, urinary incontinence and quality of life in women with stress urinary incontinence. The main questions are:

What is the effect of electrostimulation combined with pelvic floor muscle training on pelvic floor muscle function, symptoms of urinary incontinence and quality of life in women with stress urinary incontinence? What is the effect of pelvic floor muscle training program on pelvic floor muscle function, symptoms of urinary incontinence and quality of life in women with stress urinary incontinence? Which intervention is more effective - electrostimulation with pelvic floor muscle training or pelvic floor muscle training alone?

Participants will be evaluated before and after the interventions with the following methods:

International Incontinence Counseling Questionnaire - Short Form (ICIQ-SF) Pelvic floor muscle strength and endurance will be assessed with a "Pelvexiser" perineometer.

详细描述

The study involved 24 women 20-49 years old who have complained of stress urinary incontinence for at least 4 weeks, who gave at least one birth vaginally and signed the consent form. Subjects were excluded if they were pregnant, were diagnosed with vaginismus, urinary tract infections, cancer, epilepsy, pelvic organ prolapse greater than stage I, skin diseases, had undergone previous pelvic floor surgeries, had heart stimulator, or metal implant and were unable to contract the PFM. Study participants were randomly divided into two groups: the I group (n=12), in which participants underwent pelvic floor muscle training (PFMT) and the II group (n=12) in which subjects received pelvic floor muscle exercises combined with electrostimulation (PFMES).Participants were evaluated before the interventions and repeated after 4 weeks. Before and after the interventions, women's quality of life (QoL) was assessed according to the International Incontinence Counseling Questionnaire - Short Form. Perineometry with Pelvexiser perineometer was used to measure pelvic floor muscle strength and endurance and vaginal resting pressure. Statistical analysis was performed by IBM SPSS Statistics 26.0 and Microsoft Excel software 365.

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 (Outcomes Assessor)

盲法说明

outcomes were measured by gynecologists, intervention done by physiotherapist, who did not know measurements' results

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Have given birth at least once
  • Voluntary consent to participate in the study
  • Do not have concomitant diseases
  • Do not use hormonal drugs.

排除标准

  • Less than three months have passed after childbirth
  • Have heart implants or other metal implants
  • Pregnancy

结局指标

主要结局

Quality of life by International Incontinence Counseling Questionnaire - Short Form (ICIQ - SF)

时间窗: Change from Baseline Quality of Life at 4 weeks

The questionnaire consists of four items and the overall score ranges from 0 to 21, with greater values indicating increased symptom severity: 0 - no symptoms of UI, 1-5 scores - mild symptoms of UI, 6-12 scores - moderate symptoms of UI, 13-18 scores - severe symptoms of UI, 19 - 21 scores - and very severe symptoms of UI.

Resting vaginal pressure

时间窗: Change from Baseline Resting Vaginal Prressure at 4 weeks

Perineometry with Pelvexiser perineometer (mm Hg).

Pelvic floor muscle strength and endurance

时间窗: Change from Baseline Pelvic floor Muscle Strength and Endurance at 4 weeks

Perineometry with Pelvexiser perineometer (mm Hg). The higher the results- the better function of pelvic floor muscle strength and endurance.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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