Urinary Incontinence in an Inpatient Rehab Unit

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01499784
Recruitment Status : Completed
First Posted : December 26, 2011
Last Update Posted : October 27, 2015
Shirley Ryan AbilityLab
Information provided by (Responsible Party):
Anne Deutsch, Shirley Ryan AbilityLab

Brief Summary:

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 or disease Intervention/treatment Phase
Urinary Incontinence Behavioral: pelvic floor muscle training Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Can Urinary Incontinence be Treated in an In-patient Rehabilitation Setting?
Study Start Date : January 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Number of urinary incontinent episodes [ Time Frame: per day ]

Secondary Outcome Measures :
  1. Urinary incontinence severity [ Time Frame: participants will be followed for the duration of their hospital stay, an average of 2 weeks ]
    Sandvick Severity Scale

  2. ICIQ-SF [ Time Frame: participants will be followed for the duration of their hospital stay, average of 2 weeks ]
    quality of life

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01499784

Sponsors and Collaborators
Anne Deutsch
Shirley Ryan AbilityLab
Study Director: Laura Pickering, PT Shirley Ryan AbilityLab

Responsible Party: Anne Deutsch, Principal Investigator, Shirley Ryan AbilityLab Identifier: NCT01499784     History of Changes
Other Study ID Numbers: 61418
First Posted: December 26, 2011    Key Record Dates
Last Update Posted: October 27, 2015
Last Verified: October 2015

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