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临床试验/NCT03238716
NCT03238716终止不适用

Neuromuscular Re-education, Impairment-based Exercise and Electric Dry Needling vs. Neuromuscular Re-education and Impairment-based Exercise for Stress Urinary Incontinence

Alabama Physical Therapy & Acupuncture2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2017年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
24
试验地点
2
主要终点
Incontinence Impact Questionnaire - Short Form IIQ-7

研究概览

简要总结

The purpose of this research is to compare two different approaches for treating patients with stress urinary incontinence: neuromuscular re-education, impairment-based exercise and electric dry needling versus neuromuscular re-education and impairment-based exercise. Physical therapists commonly use all of these techniques to treat stress urinary incontinence. This study is attempting to find out if one treatment strategy is more effective than the other.

详细描述

Patients with stress urinary incontinence will be randomized to receive 2 treatment sessions per week for up to 6 weeks (8-12 sessions total) of either: (1) neuromuscular re-education, impairment-based exercise and electric dry needling (2) neuromuscular re-education and impairment-based exercise

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
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Aged 35 - 75 years
  • Meet the diagnosis of stress urinary incontinence - urine leakage with increased abdominal pressure from laughing, sneezing, coughing, or other physical stressors on abdominal cavity and bladder

排除标准

  • Urge urinary incontinence or mixed urinary incontinence
  • Greater than second degree prolapse
  • Previous surgical intervention related to female anatomy
  • Urinary tract infection
  • Unable to participate in movement such as walking, stair climbing, or resistance training
  • Taking medication that impacts bladder function
  • Serious cardiovascular, cerebral disease, psychiatric disorder, cognitively impaired, injury of cauda equine, and/or myelopathy
  • Sacral nerve stimulator implanted
  • Cardiac pacemaker, metal allergy, or severe needle phobia

研究组 & 干预措施

Electric DN, NM Re-ed, Exercise

Experimental

干预措施: Electric DN (Other)

Electric DN, NM Re-ed, Exercise

Experimental

干预措施: NM Re-ed (Other)

Electric DN, NM Re-ed, Exercise

Experimental

干预措施: Exercise (Other)

NM Re-ed and Exercise

Active Comparator

干预措施: NM Re-ed (Other)

NM Re-ed and Exercise

Active Comparator

干预措施: Exercise (Other)

结局指标

主要结局

Incontinence Impact Questionnaire - Short Form IIQ-7

时间窗: baseline, 6 weeks, 3 months

7 questions, each worth 0-3 points. The average score of items responded to is calculated, then multiplied by 33 1/3 to put the scores on a scale of 0 to 100. High scores indicate greater impact of incontinence.

次要结局

  • Urinary pad per day usage(baseline, 6 weeks, 3 months)
  • Urogenital Distress Inventory(baseline, 6 weeks, 3 months)
  • Global Rating of Change Scale(6 weeks, 3 months)

研究者

发起方
Alabama Physical Therapy & Acupuncture
申办方类型
Other
责任方
Principal Investigator
主要研究者

James Dunning, DPT, MSc, FAAOMPT

Primary Investigator and President of Spinal Manipulation Institute and Dry Needling Institute of the American Academy of Manipulative Therapy

Alabama Physical Therapy & Acupuncture

研究点 (2)

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