What Affects Willingness to Self-manage a Pessary?

Study Overview
=================
Brief 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. 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.

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.

Conditions
-----------------
Prolapse; Female, Prolapse, Vaginal

Intervention / Treatment
-----------------
* Other: Uncertain what intervention will be co-created


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Quantitative phase<br>Pessary using women | |
| Qualitative phase<br>Pessary using women | |
| Intervention development phase<br>Pessary using women and pessary practitioners | |
| Pilot phase<br>Pessary using women | Other: Uncertain what intervention will be co-created<br>* Uncertain what intervention will be co-created<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Through study completion, an average of 1 appointment (1 day) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age | Full years since birth | Through study completion, an average of 1 appointment (1 day) | 
| Pessary | Type and size of pessary in situ | Through study completion, an average of 1 appointment (1 day) | 
| Length of pessary management | Total months pessary used for | Through study completion, an average of 1 appointment (1 day) | 
| Comorbidities | Free text data for participant to report diagnosed health conditionns | 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 | 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) | Through study completion, an average of 1 appointment (1 day) | 
| Ethnicity | Ethnic groups in accordance with UK government agreed list of ethnicities | 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 | Through study completion, an average of 1 appointment (1 day) | 
| Education status | Women will be asked to report their highest level of education | 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. | Through study completion, an average of 1 appointment (1 day) |