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临床试验/NCT01499784
NCT01499784已完成不适用

Can Urinary Incontinence be Treated in an In-patient Rehabilitation Setting?

Anne Deutsch0 个研究点目标入组 5 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
5
主要终点
Number of urinary incontinent episodes

研究概览

简要总结

Urinary incontinence (UI) is a very common condition in women, with estimates of prevalence varying from 10% to 40% in most studies and showing a gradual increase with age. UI is a serious medical problem that can lead to urinary tract infections, low back pain, respiratory disorders, pressure sores, and an increased risk of falls. It also leads to social problems, creating embarrassment and negative self-perception for those who suffer from it. Women with urinary incontinence find themselves isolated and relatively inactive. A wide range of treatments has been used in the management of women's UI, including conservative interventions, pharmaceutical intervention, and surgery. A Cochrane Review from 2008 stated that pelvic floor muscle training (PFMT) is better than no treatment for UI and supports the recommendation that PFMT should be the first treatment line in conservative management programs for women with UI. Recently, there have been a few articles published that looked at the effectiveness of treating UI in a group-like setting with both behavioral modifications and pelvic floor exercises. One study was able to prove that group training of behavioral modification helped to reduce UI severity, increase pelvic floor strength, and reduce voiding frequency when compared to a control group.

All of the studies cited were performed in community-dwelling persons with out-patient services and interventions. Dr. Fitzgerald and her colleagues from The Rehabilitation Institute of Chicago (RIC) were able to confirm in a poster presentation that many patients admitted to an inpatient rehabilitation facility do have UI. In 2005, out of 403,697 Medicare beneficiaries admitted to a rehab hospital, 24% were incontinent. These studies were able to illustrate that UI affects all diagnoses. UI was shown to make a significant contribution to patient outcomes independent of functional status at admission. It is also a large determinant of discharge destination. In the United Kingdom in 2004, 62% of incontinent stroke patients were discharged to a sub acute home with only 5% placement for continent stroke survivors. Another study determined that urinary incontinence after having a stroke predicted a higher likelihood of an adverse outcome when controlled for age, type of stroke, and length of hospital stay. May, et. al., was able to state while in an acute rehab setting that patients with spinal cord injuries ranked bowel and bladder care, along with skin care, as most important in an education class with 12 different topics. This shows that patients find bladder function a large priority in their care, even in an in-patient setting. In the poster presentation mentioned above, many patients with UI in an acute care rehab setting do not improve Functional Independence Measure (FIM) status from admission to discharge. Currently there is no research available for the treatment of UI in an acute care rehab hospital, though it has been shown to be an issue with many of those admitted. So the question arises, "Would addressing urinary incontinence with physical therapy interventions and behavioral modifications improve incontinence in this population during the acute rehab stage?"

详细描述

This project will look at the possibility of treating in-patients with UI at RIC while in the acute rehab hospital setting to determine what positive outcomes are possible. Subjects will be provided both individual and group sessions to help educate and treat those suffering with UI. Subjects would participate in a weekly educational class of lecture and video and then perform both pelvic floor and general exercises in a group setting for the remainder of their stay. Pre- and post- values of the listed outcome measures would be taken and analyzed.

The purpose of this fellowship is to determine if, through an educational and exercise class setting, improvements can be made in women with UI in an acute rehab hospital. Also, surveys will be used to see if patients find this type of intervention satisfactory and appropriate in this level of care. Another outcome of this fellowship will be to expand this intervention to other inpatient units and day rehab sites in the RIC system.

Specific Aim #1: To determine if women with urinary incontinence in an acute care rehab setting are satisfied with a group setting to treat UI Hypothesis 1: Women with urinary incontinence in an acute care rehab setting will find a group educational and exercise class appropriate for an acute care rehab hospital setting.

Specific Aim #2: To determine if women with urinary incontinence in an acute rehab setting feel the group setting of educational class of lecture and video and exercise class was effective in reducing the amount or severity of UI Hypothesis 2: Women with urinary incontinence in an acute care rehab setting will find a group educational (lecture and video) and exercise class effective in reducing the amount or severity of UI Specific Aim #3: To determine if women's quality of life improves with treating incontinence in an inpatient rehab setting Hypothesis 3: Quality of life will improve for women with urinary incontinence treated through group educational and exercise classes in an acute care rehab setting.

Methods This is a prospective pilot study of 15 women who have been admitted to the Rehab Institute of Chicago. There will not be a control group, and all 15 women will be in the intervention group. Patients will be selected from the 4th floor inpatient unit. Diagnoses will include women with orthopedic injuries, spinal surgeries, s/p surgical procedures, and general debility due to hospitalizations. All types of incontinence will be included in the study. UI will be defined as having an episode of loss of urine in the last 3 months.

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 99 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Inclusion includes English-speaking women over the age of 18 who have been admitted to the Rehabilitation Institute of Chicago with reports of urinary incontinence in the past 3 months. Those who report "yes" to the screening questions who fit the above criteria will be screened by the principal investigator to ensure they fall into the criteria.

排除标准

  • Non-English speaking women under the age of 18, or those that do not give consent to participate in the study will not be enrolled. Also excluded will be any woman who has any chance of being pregnant or having an active urinary tract infection. No women with active infection lesions, unknown vaginal bleeding or those who have never had any kind of pelvic examination will be included in the study. Other exclusion criteria include women with a neurogenic bladder or admission FIM scores on sections Comprehension and Memory of below
  • Women with reports of significant pelvic pain or recent pelvic surgery or radiation or post-partum in last 6 months will be excluded.

结局指标

主要结局

Number of urinary incontinent episodes

时间窗: per day

次要结局

  • Urinary incontinence severity(participants will be followed for the duration of their hospital stay, an average of 2 weeks)
  • ICIQ-SF(participants will be followed for the duration of their hospital stay, average of 2 weeks)

研究者

发起方
Anne Deutsch
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Anne Deutsch

Principal Investigator

Shirley Ryan AbilityLab

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