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Recruiting NCT05750615

What Affects Willingness to Self-manage a Pessary?

Conditions: Prolapse; Female, Prolapse, Vaginal

Sex: Female
Ages: 18 Years – N/A
Enrollment: 132
Sponsor: Manchester University NHS Foundation Trust

Location: United Kingdom

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.

Eligibility Criteria

Quantitative phase inclusion criteriaWilling and able to give implied consent by completion of the questionnaireFemaleOver the age of 18 yearsHave retained a pessary for pelvic organ prolapse for a minimum of two weeksAble to speak and understand EnglishUse a ring, shaatz, cube or inflatable pessaryQualitative phase inclusion criteriaWilling and able to give informed consentFemaleOver the age of 18 yearsHave retained a pessary for pelvic organ prolapse for a minimum of two weeksSpeak English or, for those whose first or preferred language is a language other than English, speak a language there is an available interpreter forIntervention development phase inclusion criteria Pessary using womenWilling and able to give informed consentFemaleOver the age of 18 yearsHave retained a pessary for pelvic organ prolapse for a minimum of two weeksSpeak English Pessary practitionersWilling and able to give informed consentProvide 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 EnglishPilot phase inclusion criteriaWilling and able to give informed consent, review the intervention and provide written and/or verbal feedback.FemaleOver the age of 18 yearsHave retained a pessary for pelvic organ prolapse for a minimum of two weeksSpeak EnglishHave 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 criteriaLacking capacity to give implied consent by completion of the questionnaireHas a first or preferred language that is not EnglishUse a shelf, gell-horn or donut pessaryQualitative phase exclusion criteriaLacking capacity to give informed consentFirst or preferred language that is not English or a language there is an available interpreter forIntervention development phase exclusion criteria Pessary using womenLacking capacity to give informed consentDoes not speak English Pessary practitionersLacking capacity to give informed consentDoes not speak EnglishDoes not provide pessary care at a minimum of a monthly basisIntervention pilot exclusion criteriaLacking capacity to give informed consent, review the intervention and provide written and/or verbal feedback.Does not speak EnglishHave 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)

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05750615). StuddyBuddy aggregates publicly available trial information.