Motivational Interviewing in Women's Pelvic Wellness Education

NCT02758561

Last updated date
Study Location
The Ottawa Hospital, Riverside Campus
Ottawa, Ontario, K1H 7W9, Canada
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pelvic Floor Disorders, Urinary Incontinence (UI), Pelvic Prolapse Conditions
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Women ages >18 years old

- Urinary incontinence and/or pelvic organ prolapse

- First visit with urogynecologist

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Pelvic Floor Disorders, Urinary Incontinence (UI), Pelvic Prolapse ConditionsMotivational Interviewing in Women's Pelvic Wellness Education
NCT02758561
  1. Ottawa, Ontario
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Motivational Interviewing in Women's Pelvic Wellness Education
Official Title  ICMJE 2015 Motivational Interviewing in Women's Pelvic Wellness Education Project
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Pelvic Floor Disorders
  • Urinary Incontinence (UI)
  • Pelvic Prolapse Conditions
Intervention  ICMJE Behavioral: Workshop

The first 15 minutes will be an information session on either Urinary Incontinence (UI) or Pelvic Organ Prolapse (PO) led by a Nurse Continence Advisor.

The following 60 minutes will comprise a psychologist-led group discussion. The structured discussion will encourage participants to share experiences, thoughts, and feelings on pelvic floor disorders. Resistances and barriers to seeking treatment will be discussed. Decision-making processes will be explored.

During the final 15 minutes, participants will be asked to complete a survey to evaluate the workshop. The survey will assess satisfaction with the information provided, quality of group discussion, comfort level with the group experience, and their satisfaction with the roles of the nurse continence advisor and psychologist.

Study Arms  ICMJE
  • No Intervention: Standard of care
    Standard of care
  • Experimental: Workshop
    90 minute workshop on either Urinary Incontinence (UI) or Pelvic Organ Prolapse (POP)
    Intervention: Behavioral: Workshop
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 28, 2016)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 6, 2017
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02758561
Other Study ID Numbers  ICMJE 20150564-01H
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Ottawa Hospital Research Institute
Study Sponsor  ICMJE Ottawa Hospital Research Institute
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Joyce Schachter, MD, FRCSCThe Ottawa Hospital
PRS Account Ottawa Hospital Research Institute
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP