NCT03623880

Enhancing Behavioral Treatment for Women With Pelvic Floor Disorders

Completed NA Last updated 30 March 2023

What this trial tests

NA trial testing Unified Protocol in Pelvic Floor Disorders in 38 participants. Completed in 10 December 2020.

Timeline

3 September 2018

Primary endpoint
10 December 2020

10 December 2020

Quick facts

Lead sponsor	Northwestern University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	38
Start date	3 September 2018
Primary completion	10 December 2020
Estimated completion	10 December 2020
Sites	1 location across United States

Drugs / interventions tested

• Unified Protocol
• Supportive Therapy

Conditions studied

• Pelvic Floor Disorders — all drugs for Pelvic Floor Disorders →
• Anxiety — all drugs for Anxiety →
• Urinary Urgency — all drugs for Urinary Urgency →
• Urinary Incontinence — all drugs for Urinary Incontinence →

Sponsor

Northwestern University

Who can join

18 and older, female only, with Pelvic Floor Disorders or Anxiety. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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?

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Enhancing behavioral treatment for women with pelvic floor disorders: Study protocol for a pilot randomized controlled trial.
   Taple BJ, Griffith JW, Weaver C, Kenton KS. · · 2020 · cited 3× · PMID 31956723 · DOI 10.1016/j.conctc.2019.100514