Enhancing Behavioral Treatment for Women With Pelvic Floor Disorders



Status:Recruiting
Conditions:Anxiety, Anxiety, Other Indications, Overactive Bladder, Overactive Bladder, Urology
Therapuetic Areas:Gastroenterology, Nephrology / Urology, Psychiatry / Psychology, Other
Healthy:No
Age Range:18 - Any
Updated:3/15/2019
Start Date:September 3, 2018
End Date:September 2019
Contact:Bayley J Taple, MS
Email:btaple@u.northwestern.edu
Phone:3125033811

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The purpose of this proposal is to test a novel behavioral treatment - Unified Protocol
Cognitive-Behavior Therapy (UP-CBT)1 - to enhance quality of life in women with pelvic floor
disorders. Emotional distress is treatable using behavioral procedures, and effective
treatment would increase women's emotional health and help to reduce urinary symptoms (e.g.,
incontinence, frequent urination). Women with pelvic floor disorders are often seen in the
urogynecology clinic, which makes this setting ideal for offering additional interventions
that may improve their quality of life. Unfortunately, many women with pelvic floor disorders
may not receive effective behavioral treatment, such as cognitive behavior therapy, because
urogynecologists and other medical professionals may not be aware of providers in their
community who offer this treatment. The investigators will enhance treatment options by 1)
providing evidence for an all-purpose cognitive-behavioral intervention (i.e., UP-CBT), 2)
offering treatment in the urogynecology clinic, maximizing convenience, and 3) improving
clinical outcomes for these patients.

Specific Aims:

1. To demonstrate that UP-CBT is an effective form of therapy for women with lower urinary
tract symptoms.

2. To use baseline characteristics in moderation analyses to determine which women will be
most likely to have a good response to therapy.

3. To use mediation analyses to test a possible causal chain of events - Does treatment
lead to lower anxiety, which in turn leads to fewer urinary symptoms?


Inclusion Criteria:

- Female

- Age 18 years or older

- Presence of one or more of the following urinary symptoms in past 12 months and
currently seeking treatment: frequency, nocturia, urgency, leakage, hesitancy,
straining, or dribbling

- Willing and able to provide informed consent

- Anxious presentation and/or history of anxiety

- English speaking

- Willing to defer usual treatment for urinary problems

Exclusion Criteria:

- Blood in the urine, positive urine culture, signs of infection

- Pregnant, or 6 months or less postpartum

- Psychosis, dementia, or other cognitive impairment that would preclude participation

- Recent (within 6 months) pelvic or endoscopic surgery, urethral stricture, pelvic
malignancy, current chemotherapy or other cancer therapy, pelvic device or implant
complication

- Recent (within 12 months) Botox injection to the bladder or pelvic structures

- Currently in psychotherapy

- Current alcohol or substance use disorder

- Difficulty communicating in English
We found this trial at
1
site
303 East Superior Street
Chicago, Illinois 60611
Phone: 312-695-7748
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mi
from
Chicago, IL
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