- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05750615
What Affects Willingness to Self-manage a Pessary?
February 28, 2023 updated by: Manchester University NHS Foundation Trust
Understanding Factors Which Affect Willingness to Self-manage a Pessary for Pelvic Organ Prolapse: A Mixed Methods Study Aiming to Improve Access to Pessary Self-management.
Pessary self-management is defined as the patient's ability to remove and reinsert their pessary themselves at home.
Previous research has suggested that some women may prefer being able to remove and reinsert their pessary as they wish rather than wait for clinic appointments.
At the moment, not enough is known about pessary self-management, particularly what makes someone more or less likely to try pessary self-management.
The investigators would like to understand this better to try to help women overcome barriers they might face.
This study aims to collect data via both questionnaires and interviews to explore willingness to self-manage a pessary.
Using findings from the questionnaires and interviews, a group of women who use pessaries and healthcare professionals who provide pessary care will work together to develop a better way to support women to feel able and willing to manage their pessary in future.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
132
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lucy Dwyer, BNurs, MSc
- Phone Number: 01612761234
- Email: lucy.dwyer@mft.nhs.uk
Study Locations
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Manchester, United Kingdom, M13 9WU
- Recruiting
- Manchester University NHS Foundation Trust
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Contact:
- Lucy Dwyer
- Phone Number: 07830266256
- Email: lucy.dwyer@mft.nhs.uk
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Pessary using women and pessary practitioners
Description
Quantitative phase inclusion criteria
- Willing and able to give implied consent by completion of the questionnaire
- Female
- Over the age of 18 years
- Have retained a pessary for pelvic organ prolapse for a minimum of two weeks
- Able to speak and understand English
- Use a ring, shaatz, cube or inflatable pessary
Qualitative phase inclusion criteria
- Willing and able to give informed consent
- Female
- Over the age of 18 years
- Have retained a pessary for pelvic organ prolapse for a minimum of two weeks
- Speak English or, for those whose first or preferred language is a language other than English, speak a language there is an available interpreter for
Intervention development phase inclusion criteria Pessary using women
- Willing and able to give informed consent
- Female
- Over the age of 18 years
- Have retained a pessary for pelvic organ prolapse for a minimum of two weeks
- Speak English Pessary practitioners
- Willing and able to give informed consent
- Provide regular pessary care as part of clinical role (defined as insertion or removal of a woman's pessary on a minimum of a monthly basis)
- Speak English
Pilot phase inclusion criteria
- Willing and able to give informed consent, review the intervention and provide written and/or verbal feedback.
- Female
- Over the age of 18 years
- Have retained a pessary for pelvic organ prolapse for a minimum of two weeks
- Speak English
- Have no previous experience self-managing a pessary (defined as never having removed or inserted their pessary, or received any pessary self-management teaching or support from a healthcare professional)
Exclusion Criteria:
Quantitative phase exclusion criteria
- Lacking capacity to give implied consent by completion of the questionnaire
- Has a first or preferred language that is not English
- Use a shelf, gell-horn or donut pessary
Qualitative phase exclusion criteria
- Lacking capacity to give informed consent
- First or preferred language that is not English or a language there is an available interpreter for
Intervention development phase exclusion criteria Pessary using women
- Lacking capacity to give informed consent
- Does not speak English Pessary practitioners
- Lacking capacity to give informed consent
- Does not speak English
- Does not provide pessary care at a minimum of a monthly basis
Intervention pilot exclusion criteria
- Lacking capacity to give informed consent, review the intervention and provide written and/or verbal feedback.
- Does not speak English
- Have prior experience self-managing a pessary (defined as previously removing or inserting their pessary, or receiving any pessary self-management teaching or support from a healthcare professional)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Quantitative phase
Pessary using women
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Qualitative phase
Pessary using women
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Intervention development phase
Pessary using women and pessary practitioners
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|
Pilot phase
Pessary using women
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Uncertain what intervention will be co-created
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Willingness to self-manage a pessary
Time Frame: Through study completion, an average of 1 appointment (1 day)
|
Women will be asked whether they are willing or not to self-manage a pessary for prolapse.
This will be a binary yes, no or not sure answer.
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Through study completion, an average of 1 appointment (1 day)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Age
Time Frame: Through study completion, an average of 1 appointment (1 day)
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Full years since birth
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Through study completion, an average of 1 appointment (1 day)
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Pessary
Time Frame: Through study completion, an average of 1 appointment (1 day)
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Type and size of pessary in situ
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Through study completion, an average of 1 appointment (1 day)
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Length of pessary management
Time Frame: Through study completion, an average of 1 appointment (1 day)
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Total months pessary used for
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Through study completion, an average of 1 appointment (1 day)
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Comorbidities
Time Frame: Through study completion, an average of 1 appointment (1 day)
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Free text data for participant to report diagnosed health conditionns
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Through study completion, an average of 1 appointment (1 day)
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Self-management experience
Time Frame: Through study completion, an average of 1 appointment (1 day)
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The woman will be asked whether she has previously removed or inserted her pessary
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Through study completion, an average of 1 appointment (1 day)
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Self-management status
Time Frame: Through study completion, an average of 1 appointment (1 day)
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The woman will be asked whether she is currently self-managing her pessary (defined as removing and inserting it independently in between clinic appointments)
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Through study completion, an average of 1 appointment (1 day)
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Ethnicity
Time Frame: Through study completion, an average of 1 appointment (1 day)
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Ethnic groups in accordance with UK government agreed list of ethnicities
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Through study completion, an average of 1 appointment (1 day)
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Post code
Time Frame: Through study completion, an average of 1 appointment (1 day)
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Post code at home address to determine deprivation of home address in accordance with UK government index of deprivation
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Through study completion, an average of 1 appointment (1 day)
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Education status
Time Frame: Through study completion, an average of 1 appointment (1 day)
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Women will be asked to report their highest level of education
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Through study completion, an average of 1 appointment (1 day)
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Female genital self-image score (FGSIS)
Time Frame: Through study completion, an average of 1 appointment (1 day)
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Women will also be asked to complete the Female Genital Self-Image Scale (FGSIS-4), a reliable and validated 4-item questionnaire which measures women's attitude and beliefs about their genitals (Herbenick and Reece, 2010).
Scores in the FGSIS-4 range between 4-16, with a mean score of 12 in a nationally representative population of over 2000 American women (Herbenick et al., 2011).
Herbenick et al. (2011) have not determined a binary score for high and low FGSIS, however for the purpose of this study, a score of eight or less will indicate low FGSI, whereas more than eight will indicate high FGSI.
To score eight or less, a participant must disagree with all four statements describing genital self-image therefore this is deemed to accurately represent FGSIS-4.
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Through study completion, an average of 1 appointment (1 day)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 25, 2022
Primary Completion (Anticipated)
March 1, 2024
Study Completion (Anticipated)
March 1, 2024
Study Registration Dates
First Submitted
August 19, 2022
First Submitted That Met QC Criteria
February 28, 2023
First Posted (Actual)
March 1, 2023
Study Record Updates
Last Update Posted (Actual)
March 1, 2023
Last Update Submitted That Met QC Criteria
February 28, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B01328
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is no plan to make IPD available to other researchers
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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