Enhancing Behavioral Treatment for Women With Pelvic Floor Disorders
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Northwestern University
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - Profile V2.0: Adult v1.0 - Anxiety 4a T Score
Study Overview
Brief Summary
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:
- To demonstrate that UP-CBT is an effective form of therapy for women with lower urinary tract symptoms.
- To use baseline characteristics in moderation analyses to determine which women will be most likely to have a good response to therapy.
- 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?
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Arms & Interventions
Unified Protocol
This is a type of CBT for emotional distress.
Intervention: Unified Protocol (Behavioral)
Supportive Therapy
This is a commonly-used form of all-purpose psychotherapy, often used as a comparator in CBT clinical trials.
Intervention: Supportive Therapy (Behavioral)
Outcomes
Primary Outcomes
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - Profile V2.0: Adult v1.0 - Anxiety 4a T Score
Time Frame: 1 week; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up
Self-report measure of anxiety symptoms. Min T Score = 40.3; Max T Score = 81.6. Raw scores are summed, then converted to T Scores from a lookup table. Higher T scores represent a worse outcome (i.e., greater number of anxiety symptoms).
Urinary Distress Inventory (UDI-6)
Time Frame: 3 months; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up
Self-report measure of urinary symptoms and bother. Scores are scale scores: mean value of items answered multiplied by 25; min scale score = 0; max scale score = 100. This scale score can be combined with the scale scores of the Pelvic Organ Prolapse Distress Inventory (POPDI-6) and Colorectal-Anal Distress Inventory (CRAD-8) to form the Pelvic Floor Distress Inventory (PFDI-20) summary score: add three scale scores together (range 0 to 300). Higher score indicates worse outcome (i.e., greater urinary symptoms and bother).
Secondary Outcomes
- Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - Profile V2.0: Adult v1.0 - Ability to Participate in Social Roles and Activities 4a T Score(1 week; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up)
- Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - Profile V2.0: Adult v1.0 - Pain Interference 4a T Score(1 week; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up)
- PROMIS Pain Intensity(1 week; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up)
- Colorectal-Anal distress Inventory 8 (CRAD-8)(3 months; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up)
- Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6)(3 months; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up)
- Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - Profile V2.0: Adult v1.0 - Depression 4a T Score(1 week; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up)
- Patient Global Impression of Improvement (PGI-I)(This item assess how the patient is "right now" compared to beginning treatment; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up)
- Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - Profile V2.0: Adult v1.0 - Physical Function 4a T Score(1 week; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up)
- Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - Profile V2.0: Adult v1.0 - Fatigue 4a T Score(1 week; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up)
- Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - Profile V2.0: Adult v1.0 - Sleep Disturbance 4a T Score(1 week; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up)
Investigators
James W Griffith
Associate Professor
Northwestern University