Urinary Incontinence in an Inpatient Rehab Unit

This study has been completed.
Sponsor:
Collaborator:
Rehabilitation Institute of Chicago
Information provided by (Responsible Party):
Anne Deutsch, Rehabilitation Institute of Chicago
ClinicalTrials.gov Identifier:
NCT01499784
First received: December 20, 2011
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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?"


Condition Intervention
Urinary Incontinence
Behavioral: pelvic floor muscle training

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Can Urinary Incontinence be Treated in an In-patient Rehabilitation Setting?

Resource links provided by NLM:


Further study details as provided by Rehabilitation Institute of Chicago:

Primary Outcome Measures:
  • Number of urinary incontinent episodes [ Time Frame: per day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Urinary incontinence severity [ Time Frame: participants will be followed for the duration of their hospital stay, an average of 2 weeks ] [ Designated as safety issue: No ]
    Sandvick Severity Scale

  • ICIQ-SF [ Time Frame: participants will be followed for the duration of their hospital stay, average of 2 weeks ] [ Designated as safety issue: No ]
    quality of life


Enrollment: 5
Study Start Date: January 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pelvic Floor muscle Training
educational class for behavioral modification and group exercise class for pelvic floor muscle training
Behavioral: pelvic floor muscle training
behavioral modification and pelvic floor muscle training

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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 4. Women with reports of significant pelvic pain or recent pelvic surgery or radiation or post-partum in last 6 months will be excluded.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01499784

Sponsors and Collaborators
Anne Deutsch
Rehabilitation Institute of Chicago
Investigators
Study Director: Laura Pickering, PT Rehabilitation Institute of Chicago
  More Information

No publications provided

Responsible Party: Anne Deutsch, Principal Investigator, Rehabilitation Institute of Chicago
ClinicalTrials.gov Identifier: NCT01499784     History of Changes
Other Study ID Numbers: 61418
Study First Received: December 20, 2011
Last Updated: May 20, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 18, 2014