Enhancing Behavioral Treatment for Women With Pelvic Floor Disorders

Northwestern University

Status: Completed

Conditions: Urinary Straining; Urinary Urgency; Pelvic Floor Disorders; Lower Urinary Tract Symptoms; Nocturia; Anxiety; Urinary Hesitancy; Urinary Frequency/Urgency; Urinary Incontinence

Treatments: Behavioral: Supportive Therapy; Behavioral: Unified Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT03623880

STU00207124

Details and patient eligibility

About

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?

Enrollment: 38 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Unified Protocol

Experimental group

Description:

This is a type of CBT for emotional distress.

Treatment:

Behavioral: Unified Protocol

Supportive Therapy

Active Comparator group

Description:

This is a commonly-used form of all-purpose psychotherapy, often used as a comparator in CBT clinical trials.

Treatment:

Behavioral: Supportive Therapy