Pelvic Floor DisordersNCT02758561
Motivational Interviewing in Women's Pelvic Wellness Education
A study testing Workshop in people with Pelvic Floor Disorders and Urinary Incontinence (UI), run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Floor Disorders, Urinary Incontinence (UI), Pelvic Prolapse Conditions
- What is being tested?
- Workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- May 2016to 6 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women ages >18 years old
- Urinary incontinence and/or pelvic organ prolapse
- First visit with urogynecologist
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 2015 Motivational Interviewing in Women's Pelvic Wellness Education Project
This pilot study will assess the feasibility and acceptability of an educational workshop on pelvic floor disorders and its potential impact on decisional conflict.
Read the 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.
- Being tested
- Workshop
- Keywords
- decisional aid, workshops, urinary incontinence, pelvic organ prolapse, pelvic floor dysfunction, decisional conflict
- Medical subject headings
- Pelvic Floor Disorders, Urinary Incontinence, Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WorkshopBehavioural
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 group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | Standard of care |
| Workshop | Experimental | 90 minute workshop on either Urinary Incontinence (UI) or Pelvic Organ Prolapse (POP) Receives: Behavioral: Workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in "Decisional Conflict" between baseline and followup, as measured by the Decisional Conflict Scale (O'Connor 1995).
The decisional conflict scale (DCS) is a validated scale that measures (a) perceived uncertainty between options, (b) factors contributing to uncertainty (feeling uninformed, unclear about values, unsupported in decision making), and (c) factors contributing to effective decision making (feeling the choice is informed, values-based, likely to be implemented, and satisfaction with the decision). 13 A total decisional conflict score from 0 (no decisional conflict) to 100 (extremely high decisional conflict) is given, as well as five sub-scores for each factor listed above.
Measured: 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 (1)
Participant satisfaction with the workshop.
Non-validated questionnaire addressing participants' perceived satisfaction with the following aspects of the workshop: group discussion, the information session, and the workshop as a whole. In addition there are four free text questions: 1) What changes will you make in your decision for treatment as a result of this workshop?; 2)Tell us about one thing you found most valuable in this workshop; 3)What would you change about this workshop?; 4) Other comments
Measured: This will be measured using a survey administered to participants immediately following the workshop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2017
- Study completion6 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor DisordersStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Joyce Schachter, MD, FRCSC, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02758561
- Sponsor's protocol ID
- 20150564-01H
- Status last verified
- Mar 2019
- First submitted
- 22 Dec 2015
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 2015 Motivational Interviewing in Women's Pelvic Wellness Education Project
- ClinicalTrials.gov ID
- NCT02758561
- Acronym / sponsor ID
- 20150564-01H
- Keywords
- decisional aid, workshops, urinary incontinence, pelvic organ prolapse, pelvic floor dysfunction, decisional conflict
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- May 2016
- Primary completion
- May 2017 (actual)
- Study completion
- 6 Nov 2017 (actual)
- First posted
- 2 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –Standard of care |
| Workshop | Experimental | Behavioral: Workshop90 minute workshop on either Urinary Incontinence (UI) or Pelvic Organ Prolapse (POP) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women ages >18 years old
- Urinary incontinence and/or pelvic organ prolapse
- First visit with urogynecologist
Key exclusion criteria (6 listed)
- Anal incontinence
- Previous pelvic radiation therapy
- Requirement for a Substitute Decision Maker
- Inability to attend the workshop
- Unwilling to attend an English-language workshop
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WorkshopThe 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. | Behavioural | Workshop |
Primary outcome
Change in "Decisional Conflict" between baseline and followup, as measured by the Decisional Conflict Scale (O'Connor 1995).
Time frame: 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.
The decisional conflict scale (DCS) is a validated scale that measures (a) perceived uncertainty between options, (b) factors contributing to uncertainty (feeling uninformed, unclear about values, unsupported in decision making), and (c) factors contributing to effective decision making (feeling the choice is informed, values-based, likely to be implemented, and satisfaction with the decision). 13 A total decisional conflict score from 0 (no decisional conflict) to 100 (extremely high decisional conflict) is given, as well as five sub-scores for each factor listed above.
1 secondary outcome
Participant satisfaction with the workshop.
Time frame: This will be measured using a survey administered to participants immediately following the workshop
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joyce Schachter, MD, FRCSC principal investigator
The Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Workshop in people with Pelvic Floor Disorders and Urinary Incontinence (UI), run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in "Decisional Conflict" between baseline and followup, as measured by the Decisional Conflict Scale (O'Connor 1995). (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2019.