What Affects Willingness to Self-manage a Pessary?

NHS Foundation Trust

Status

Enrolling

Conditions

Prolapse, Vaginal

Prolapse; Female

Treatments

Other: Uncertain what intervention will be co-created

Study type

Observational

Funder types

Other

Identifiers

NCT05750615

B01328

Details and patient eligibility

About

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.

Enrollment

132 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)