Clinical trial NCT05750615: What Affects Willingness to Self-manage a Pessary?
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prolapse; Female
Prolapse, Vaginal
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2023-03-01
Enrollment: 132
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pessary using women and pessary practitioners

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.


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)

Primary outcomes:
measure: Willingness to self-manage a pessary
timeFrame: Through study completion, an average of 1 appointment (1 day)
Secondary outcomes:
measure: Age
timeFrame: Through study completion, an average of 1 appointment (1 day)
measure: Pessary
timeFrame: Through study completion, an average of 1 appointment (1 day)
measure: Length of pessary management
timeFrame: Through study completion, an average of 1 appointment (1 day)
measure: Comorbidities
timeFrame: Through study completion, an average of 1 appointment (1 day)
measure: Self-management experience
timeFrame: Through study completion, an average of 1 appointment (1 day)
measure: Self-management status
timeFrame: Through study completion, an average of 1 appointment (1 day)
measure: Ethnicity
timeFrame: Through study completion, an average of 1 appointment (1 day)
measure: Post code
timeFrame: Through study completion, an average of 1 appointment (1 day)
measure: Education status
timeFrame: Through study completion, an average of 1 appointment (1 day)
measure: Female genital self-image score (FGSIS)
timeFrame: Through study completion, an average of 1 appointment (1 day)
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
Study officials:
References: