Prolapse; FemaleNCT05750615
What Affects Willingness to Self-manage a Pessary?
An observational study of Prolapse; Female and Prolapse, Vaginal, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Prolapse; Female, Prolapse, Vaginal
- What is being tested?
- Uncertain what intervention will be co-created
- How many people
- 132 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Aug 2022to Mar 2024
- Phase
- Observational
- 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
Study population: Pessary using women and pessary practitioners
Who may be able to join
None listed.
Who cannot join
- 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
Show all 17Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Manchester University NHS Foundation Trust
Manchester, M13 9WU
Lucy Dwyer, 07830266256, lucy.dwyer@mft.nhs.uk
About this study
Official title: 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.
- Conditions
- Prolapse; Female, Prolapse, Vaginal
- Being tested
- Uncertain what intervention will be co-created
- Medical subject headings
- Prolapse, Uterine Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uncertain what intervention will be co-createdOther
Uncertain what intervention will be co-created
| Study group | Role | What they receive |
|---|---|---|
| Quantitative phase | Pessary using women | |
| Qualitative phase | Pessary using women | |
| Intervention development phase | Pessary using women and pessary practitioners | |
| Pilot phase | Pessary using women Receives: Other: Uncertain what intervention will be co-created |
What is being measured
The primary outcome is the main question the study is designed to answer.
Willingness to self-manage a pessary
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.
Measured: Through study completion, an average of 1 appointment (1 day)
Secondary outcomes (10)
Age
Full years since birth
Measured: Through study completion, an average of 1 appointment (1 day)
Pessary
Type and size of pessary in situ
Measured: Through study completion, an average of 1 appointment (1 day)
Length of pessary management
Total months pessary used for
Measured: Through study completion, an average of 1 appointment (1 day)
Comorbidities
Free text data for participant to report diagnosed health conditionns
Measured: Through study completion, an average of 1 appointment (1 day)
Self-management experience
The woman will be asked whether she has previously removed or inserted her pessary
Measured: Through study completion, an average of 1 appointment (1 day)
Self-management status
The woman will be asked whether she is currently self-managing her pessary (defined as removing and inserting it independently in between clinic appointments)
Measured: Through study completion, an average of 1 appointment (1 day)
Ethnicity
Ethnic groups in accordance with UK government agreed list of ethnicities
Measured: Through study completion, an average of 1 appointment (1 day)
Post code
Post code at home address to determine deprivation of home address in accordance with UK government index of deprivation
Measured: Through study completion, an average of 1 appointment (1 day)
Education status
Women will be asked to report their highest level of education
Measured: Through study completion, an average of 1 appointment (1 day)
Female genital self-image score (FGSIS)
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.
Measured: Through study completion, an average of 1 appointment (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start25 Aug 2022
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolapse; FemaleStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750615
- Sponsor's protocol ID
- B01328
- Status last verified
- Feb 2023
- First submitted
- 19 Aug 2022
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IPD available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05750615
- Acronym / sponsor ID
- B01328
- Conditions
- Prolapse; Female, Prolapse, Vaginal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Study start
- 25 Aug 2022 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 1 Mar 2023 (actual)
- 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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Quantitative phase | – | –Pessary using women |
| Qualitative phase | – | –Pessary using women |
| Intervention development phase | – | –Pessary using women and pessary practitioners |
| Pilot phase | – | Other: Uncertain what intervention will be co-createdPessary using women |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pessary using women and pessary practitioners
Key inclusion criteria (0 listed)
Key exclusion criteria (17 listed)
- 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
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 |
|---|---|---|
| Uncertain what intervention will be co-createdUncertain what intervention will be co-created | Other | Pilot phase |
Primary outcome
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.
10 secondary outcomes
Age
Time frame: Through study completion, an average of 1 appointment (1 day)
Pessary
Time frame: Through study completion, an average of 1 appointment (1 day)
Length of pessary management
Time frame: Through study completion, an average of 1 appointment (1 day)
Comorbidities
Time frame: Through study completion, an average of 1 appointment (1 day)
Self-management experience
Time frame: Through study completion, an average of 1 appointment (1 day)
Self-management status
Time frame: Through study completion, an average of 1 appointment (1 day)
Ethnicity
Time frame: Through study completion, an average of 1 appointment (1 day)
Post code
Time frame: Through study completion, an average of 1 appointment (1 day)
Education status
Time frame: Through study completion, an average of 1 appointment (1 day)
Female genital self-image score (FGSIS)
Time frame: Through study completion, an average of 1 appointment (1 day)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Individual participant dataSharing planned: No. There is no plan to make IPD available to other researchers
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prolapse; Female and Prolapse, Vaginal, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
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 0 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 1 Mar 2023. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucy Dwyer, BNurs, MSc (01612761234, lucy.dwyer@mft.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Willingness to self-manage a pessary (time frame: Through study completion, an average of 1 appointment (1 day)). 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 1 Mar 2023.