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临床试验/NCT04298671
NCT04298671已完成不适用

Yoga-Pilates Exercise & the Effects on Urethral Rhabdosphincter Morphology and Stress Urinary Incontinence

Oregon Health and Science University2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2020年10月13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
78
试验地点
2
主要终点
Assess the change in stress urinary incontinence severity and quality of life symptoms pre/post intervention.

研究概览

简要总结

This is a prospective interventional study conducted at Oregon Health & Science University that will measure the pre- and post-intervention characteristics of women with stress urinary incontinence undergoing an 8-week home yoga-Pilates intervention. The investigators plan to deliver this method of exercise to patients through a web-based video in order to increase accessibility and compliance and decrease patient costs. The investigators will assess changes using a pre- and post-treatment 1-day voiding diary, answers to questionnaires International Consultation on Incontinence Questionnaire-Short Form and Patient Global Impression of Improvement questionnaire), transperineal ultrasound, and physical exam.

详细描述

Stress urinary incontinence (SUI) affects up to 1/3 of women and negatively impacts multiple aspects of a woman's life. Pelvic floor physical therapy has been shown to improve stress incontinence through multiple mechanisms, including rhabdosphincter hypertrophy. Yoga and Pilates have also been shown to improve stress incontinence but there is a key gap in understanding how yoga-Pilates impacts urethral function and if these exercises represent a viable option for treating SUI.

To fill this gap a new exercise is proposed: a web-based 8-week yoga-Pilates pelvic floor workout. The investigators plan to enroll women with SUI and compare urethral rhabdosphincter cross-sectional area in a pre-post intervention study. The investigators will also administer validated quality of life and severity measures for SUI to evaluate the potential efficacy of yoga-Pilates. The overarching goal of this project is to determine how yoga-Pilates impact urethral function and if these exercises decrease SUI symptoms.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • English-speaking
  • >50% episodes of leakage are stress over urge incontinence on a 1-day voiding diary and/OR an answer of "when you are performing some physical activities, such as coughing, sneezing, lifting, or exercise" on the 3-Incontinence Questions (3IQ) Questionnaire
  • Access to the Internet and active email address

排除标准

  • Inability to perform yoga or Pilates due to mobility issues (specifically, inability to get up from chair without assistance or to get up from prone position on floor without assistance)
  • Chronic back or neck injury that would prevent yoga or Pilates
  • Multiple sclerosis and other neurological disorders such as stroke
  • Engaged in yoga, Pilates, or pelvic floor physical therapy in past 6 months
  • Current pregnancy or pregnancy in the last 6 months
  • Untreated urinary tract infection (UTI), unevaluated hematuria, history of >3 diagnosed UTIs in past year
  • History of bladder or rectal fistula
  • Pelvic cancer or radiation
  • Interstitial cystitis or chronic pelvic pain
  • Congenital defect leading to urinary incontinence
  • Prior anti-incontinence or urethral surgery, prior surgery for pelvic floor disorder
  • Current symptomatic pelvic organ prolapse (Stage 2 or greater on exam, i.e. prolapse more than 1cm beyond the hymen)
  • Majority of incontinence episodes related to urgency urinary incontinence

结局指标

主要结局

Assess the change in stress urinary incontinence severity and quality of life symptoms pre/post intervention.

时间窗: 8 weeks

The investigators hypothesize that participants will report a minimally important change score difference of -2.5 utilizing the International Consultation on Incontinence Questionnaire-Short Form (range 0-21, lower scores indicate less bother from incontinence).

Estimate the effect of an 8-week intervention on urethral rhabdosphincter morphology as measured by transperineal ultrasound.

时间窗: 8 weeks

The investigators hypothesize that this program will cause hypertrophy of the urethral rhabdosphincter with an increase in urethral cross sectional area of 0.25cm2 +/- 0.6cm2.

次要结局

  • Assess the change in Patient Global Impression of Improvement (PGI-I) post-intervention(8 weeks)
  • Assess the change in number of incontinence episodes within a 24-hour period post-intervention using a 24-hour voiding diary.(8 weeks)
  • Assess the effect of the intervention on the levator hiatus area and anteroposterior diameter using transperineal ultrasound.(8 weeks)
  • Assess the effect of the intervention on the degree of bladder neck descent using transperineal ultrasound.(8 weeks)

研究者

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

Sara Cichowski

Principal Investigator

Oregon Health and Science University

研究点 (2)

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