Group Learning Achieves Decreased Incidents of Lower Urinary Symptoms



Status:Completed
Conditions:Urology, Urology
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:55 - Any
Updated:10/21/2017
Start Date:September 2013
End Date:December 2016

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This three-site randomized controlled trial compares the effectiveness and cost-effectiveness
of a group-administered behavioral treatment program to no treatment. Women with stress,
urgency, or mixed urinary incontinence will be recruited and screened centrally, evaluated
clinically at each of three study sites, and random assigned to one of two treatment arms: 1.
Group behavioral treatment or 2. No treatment. Group treatment modalities have the potential
to reach a larger population of older women with urinary incontinence, not only in the
traditional medical settings, but also in community settings. The investigators hypothesize
that group behavioral treatment will be more effective than no treatment. The investigators
hypothesize that the group treatment will be cost-effective compared to no treatment.


Inclusion Criteria:

1. Female

2. Aged 55 years or older

3. Ability to understand, read and write English

4. Stress, urgency, or mixed urgency and stress urinary incontinence (UI) (by self
report)

5. On the International Consultation on Incontinence Modular Questionnaire - Short Form
(ICIQ UI-SF), frequency of leakage at least a 1 ("about once a week or less often") on
item #1 and volume of urine loss at least a 2 ("a small amount") on item #2.

6. Symptoms of three months duration or longer (on history)

7. Passing score (i.e., categorized as "probably not demented") on the MiniCog Test

8. Timed "Up and Go" Test (TUG) score of 20 seconds or less

9. Willing to undergo vaginal/pelvic examination

10. Signed informed consent form

Exclusion Criteria:

1. History of renal, bladder, uterine, ovarian, urethral, anal or rectal cancer,
radiation therapy to the pelvis for any cancer/malignancy, or any active
cancer/malignancy (except skin cancer)

2. Non-ambulatory (participant confined to bed or wheelchair)

3. Persistent pelvic pain (defined as daily pelvic pain > 3 months)

4. History of neurologic or end-stage diseases (e.g. cerebral vascular accident (CVA),
Parkinson's disease, multiple sclerosis, epilepsy, spinal cord tumor or trauma, spina
bifida, symptomatic herniated disc)

5. Previous treatment or current participation in a research study for UI, including
surgery or formal behavioral treatment (pelvic floor muscle training, biofeedback,
pelvic floor electrical stimulation, percutaneous tibial nerve stimulation, sacral
neuromodulation, botox or other periurethral injection)

6. Currently taking urinary incontinence or overactive bladder medications

7. History of other urinary conditions or procedures that may affect continence status
(e.g. urethral diverticula, previous augmentation cystoplasty or artificial urinary
sphincter; implanted nerve stimulators for urinary symptoms)

8. Participation in any drug/device research study.

9. Pelvic organ prolapse protruding past the introitus (at rest or persisting after
strain)

10. Evidence of urinary tract infection (UTI) by urine dipstick (leukocytes +1 or greater,
nitrites +1 or greater, leukocytes alone (w/o nitrites) +2 or greater, or presence of
hematuria > +1). Participants may be re-screened after treatment with antibiotics or
if hematuria work-up is negative.

11. History of 2 or more recurrent UTI's within the past year; more than one UTI within
past 6 months

12. Post void residual urine volume 150 cc or more.

13. Unstable medical condition (as determined by site PI)
We found this trial at
4
sites
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Birmingham, Alabama 35233
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Birmingham, AL
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Philadelphia, Pennsylvania 19104
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Royal Oak, Michigan 48073
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Royal Oak, MI
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