What Affects Willingness to Self-manage a Pessary?

NCT ID: NCT05750615

Last Updated: 2023-03-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 132 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-25
• Study Completion Date: 2024-03-31

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.

Conditions

Prolapse; Female; Prolapse, Vaginal

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Quantitative phase

Pessary using women

No interventions assigned to this group

Qualitative phase

Pessary using women

No interventions assigned to this group

Intervention development phase

Pessary using women and pessary practitioners

No interventions assigned to this group

Pilot phase

Pessary using women

Uncertain what intervention will be co-created

Intervention Type: OTHER

Uncertain what intervention will be co-created

Interventions

Uncertain what intervention will be co-created

Uncertain what intervention will be co-created

Intervention Type: OTHER

Eligibility Criteria

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

• 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

• 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

• 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

• 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

• Lacking capacity to give informed consent
• First or preferred language that is not English or a language there is an available interpreter for

• 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

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Manchester University NHS Foundation Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Manchester University NHS Foundation Trust

Manchester, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Lucy Dwyer, BNurs, MSc

Role: CONTACT

lucy.dwyer@mft.nhs.uk

01612761234

Facility Contacts

Lucy Dwyer

Role: primary

lucy.dwyer@mft.nhs.uk

07830266256

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

B01328

Identifier Type: -

Identifier Source: org_study_id