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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quantitative phase | Pessary using women | ||
| Qualitative phase | Pessary using women | ||
| Intervention development phase | Pessary using women and pessary practitioners | ||
| Pilot phase | Pessary using women |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Uncertain what intervention will be co-created | Other | Uncertain what intervention will be co-created |
|
| 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) |
| 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 |
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Quantitative phase inclusion criteria
Qualitative phase inclusion criteria
Intervention development phase inclusion criteria Pessary using women
Pilot phase inclusion criteria
Exclusion Criteria:
Quantitative phase exclusion criteria
Qualitative phase exclusion criteria
Intervention development phase exclusion criteria Pessary using women
Intervention pilot exclusion criteria
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Pessary using women and pessary practitioners
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lucy Dwyer, BNurs, MSc | Contact | 01612761234 | lucy.dwyer@mft.nhs.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manchester University NHS Foundation Trust | Recruiting | Manchester | M13 9WU | United Kingdom |
There is no plan to make IPD available to other researchers
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 4, 2022 | Aug 22, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011391 | Prolapse |
| D014596 | Uterine Prolapse |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
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| 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) |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D056887 | Pelvic Organ Prolapse |