Enhancing Behavioral Treatment for Women With Pelvic Floor Disorders

NCT03623880 | Completed

• 1 other identifier: STU00207124
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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. 1.To demonstrate that UP-CBT is an effective form of therapy for women with lower urinary tract symptoms.
2. 2.To use baseline characteristics in moderation analyses to determine which women will be most likely to have a good response to therapy.
3. 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

Outcome Measures

Primary Outcomes (2)

• Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - Profile V2.0: Adult v1.0 - Anxiety 4a T Score

  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).

  1 week; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up

• Urinary Distress Inventory (UDI-6)

  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).

  3 months; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up

Secondary Outcomes (10)

• 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

• 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

• 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-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

Study Arms (2)

Unified Protocol

EXPERIMENTAL

This is a type of CBT for emotional distress.

Behavioral: Unified Protocol

Supportive Therapy

ACTIVE COMPARATOR

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

Behavioral: Supportive Therapy

Interventions

Unified Protocol 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.

Unified Protocol

Supportive Therapy BEHAVIORAL

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

Supportive Therapy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• 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.

  PMID: 31956723 DERIVED

MeSH Terms

Conditions

Pelvic Floor Disorders; Anxiety Disorders; Urinary Incontinence; Nocturia; Lower Urinary Tract Symptoms

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases; Mental Disorders; Urination Disorders; Urologic Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 3, 2018
• First Posted: August 9, 2018
• Study Start: September 3, 2018
• Primary Completion: December 10, 2020
• Study Completion: December 10, 2020
• Last Updated: March 30, 2023

Record last verified: 2023-03

Locations

US (1)