Enhancing Behavioral Treatment for Women With Pelvic Floor Disorders

NCT ID: NCT03623880

Last Updated: 2023-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-03
• Study Completion Date: 2020-12-10

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:

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?

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Unified Protocol

This is a type of CBT for emotional distress.

Group Type: EXPERIMENTAL

Unified Protocol

Intervention Type: BEHAVIORAL

The unified protocol is a form of cognitive behavior therapy focused on helping the person reduce emotional distress through cognitive changes and behavioral skills. Exercises included confronting emotional-driven behaviors and mindfulness activities.

Supportive Therapy

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

Group Type: ACTIVE_COMPARATOR

Supportive Therapy

Intervention Type: BEHAVIORAL

Supportive therapy seeks to improve self-esteem, aid the patient with problem solving, and provide structured support using empathetic listening.

Interventions

Unified Protocol

The unified protocol is a form of cognitive behavior therapy focused on helping the person reduce emotional distress through cognitive changes and behavioral skills. Exercises included confronting emotional-driven behaviors and mindfulness activities.

Intervention Type: BEHAVIORAL

Supportive Therapy

Supportive therapy seeks to improve self-esteem, aid the patient with problem solving, and provide structured support using empathetic listening.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

James W Griffith

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Northwestern University

Chicago, Illinois, United States

Countries

United States

References

Taple BJ, Griffith JW, Weaver C, Kenton KS. Enhancing behavioral treatment for women with pelvic floor disorders: Study protocol for a pilot randomized controlled trial. Contemp Clin Trials Commun. 2020 Jan 3;17:100514. doi: 10.1016/j.conctc.2019.100514. eCollection 2020 Mar.

Reference Type: DERIVED

PMID: 31956723 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

STU00207124

Identifier Type: -

Identifier Source: org_study_id