Clinical trial NCT02758561: Motivational Interviewing in Women's Pelvic Wellness Education
Official title: 2015 Motivational Interviewing in Women's Pelvic Wellness Education Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Floor Disorders
Urinary Incontinence (UI)
Pelvic Prolapse Conditions
Keywords: decisional aid
workshops
urinary incontinence
pelvic organ prolapse
pelvic floor dysfunction
decisional conflict
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2016-05-02
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This pilot study will assess the feasibility and acceptability of an educational workshop on pelvic floor disorders and its potential impact on decisional conflict.

Detailed description: Pelvic floor disorders can significantly affect a woman's quality of life, yet many feel uncomfortable openly discussing these topics. Treatments include lifestyle modification, medications, and/or surgery. "Decisional conflict" arises when patients have difficulty choosing between several viable treatment options. Factors contributing to decisional conflict include biased information, poor peer support, and unaddressed fears. Effective counselling may help address these factors.

There are few studies on how decision coaching can help women with prolapse and incontinence reach a satisfactory decision about treatment. This study aims to use the principals of shared decision making to address decisional conflict surrounding treatment for pelvic floor disorders. Specifically, the investigators will evaluate the feasibility and acceptability of small group workshops on pelvic organ prolapse and urinary incontinence led by a nurse continence advisor and a psychologist (decision coach).

Results of this study will inform future development of interdisciplinary, patient-centered approaches to enhanced decision making in women's health.

Eligibility criteria: Inclusion Criteria:

* Women ages \>18 years old
* Urinary incontinence and/or pelvic organ prolapse
* First visit with urogynecologist

Exclusion Criteria:

* Anal incontinence
* Previous pelvic radiation therapy
* Requirement for a Substitute Decision Maker
* Inability to attend the workshop
* Unwilling to attend an English-language workshop
* Unwilling to complete English-language surveys

Primary outcomes:
measure: Change in "Decisional Conflict" between baseline and followup, as measured by the Decisional Conflict Scale (O'Connor 1995).
timeFrame: The Decisional Conflict Scale (DCS), will be administered to participants in the control and intervention groups at baseline and first follow up visit, approx. 3 months later.
Secondary outcomes:
measure: Participant satisfaction with the workshop.
timeFrame: This will be measured using a survey administered to participants immediately following the workshop
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital, Riverside Campus
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: Joyce Schachter, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: