What Affects Willingness to Self-manage a Pessary?

NCT05750615 | Unknown

• 1 other identifier: B01328
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (10)

• Age

  Through study completion, an average of 1 appointment (1 day)

• Pessary

  Through study completion, an average of 1 appointment (1 day)

• Length of pessary management

  Through study completion, an average of 1 appointment (1 day)

• Comorbidities

  Through study completion, an average of 1 appointment (1 day)

• Self-management experience

  Through study completion, an average of 1 appointment (1 day)

Study Arms (4)

Quantitative phase

Pessary using women

Qualitative phase

Pessary using women

Intervention development phase

Pessary using women and pessary practitioners

Pilot phase

Pessary using women

Other: Uncertain what intervention will be co-created

Interventions

Uncertain what intervention will be co-created OTHER

Uncertain what intervention will be co-created

Pilot phase

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pessary using women and pessary practitioners

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead

Study Sites (1)

Manchester University NHS Foundation Trust

Manchester, M13 9WU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Prolapse; Uterine Prolapse

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pelvic Organ Prolapse

Central Study Contacts

Lucy Dwyer, BNurs, MSc

CONTACT

01612761234; lucy.dwyer@mft.nhs.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: March 1, 2023
• Study Start: August 25, 2022
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)