What Affects Willingness to Self-manage a Pessary?

February 28, 2023 updated by: Manchester University NHS Foundation Trust

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
132

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
      • Manchester, United Kingdom, M13 9WU
        • Recruiting
        • Manchester University NHS Foundation Trust
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pessary using women and pessary practitioners

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Uncertain what intervention will be co-created

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Willingness to self-manage a pessary
Time Frame: Through study completion, an average of 1 appointment (1 day)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Age
Time Frame: Through study completion, an average of 1 appointment (1 day)
Full years since birth
Through study completion, an average of 1 appointment (1 day)
Pessary
Time Frame: Through study completion, an average of 1 appointment (1 day)
Type and size of pessary in situ
Through study completion, an average of 1 appointment (1 day)
Length of pessary management
Time Frame: Through study completion, an average of 1 appointment (1 day)
Total months pessary used for
Through study completion, an average of 1 appointment (1 day)
Comorbidities
Time Frame: Through study completion, an average of 1 appointment (1 day)
Free text data for participant to report diagnosed health conditionns
Through study completion, an average of 1 appointment (1 day)
Self-management experience
Time Frame: Through study completion, an average of 1 appointment (1 day)
The woman will be asked whether she has previously removed or inserted her pessary
Through study completion, an average of 1 appointment (1 day)
Self-management status
Time Frame: Through study completion, an average of 1 appointment (1 day)
The woman will be asked whether she is currently self-managing her pessary (defined as removing and inserting it independently in between clinic appointments)
Through study completion, an average of 1 appointment (1 day)
Ethnicity
Time Frame: Through study completion, an average of 1 appointment (1 day)
Ethnic groups in accordance with UK government agreed list of ethnicities
Through study completion, an average of 1 appointment (1 day)
Post code
Time Frame: Through study completion, an average of 1 appointment (1 day)
Post code at home address to determine deprivation of home address in accordance with UK government index of deprivation
Through study completion, an average of 1 appointment (1 day)
Education status
Time Frame: Through study completion, an average of 1 appointment (1 day)
Women will be asked to report their highest level of education
Through study completion, an average of 1 appointment (1 day)
Female genital self-image score (FGSIS)
Time Frame: Through study completion, an average of 1 appointment (1 day)
Women will also be asked to complete the Female Genital Self-Image Scale (FGSIS-4), a reliable and validated 4-item questionnaire which measures women's attitude and beliefs about their genitals (Herbenick and Reece, 2010). Scores in the FGSIS-4 range between 4-16, with a mean score of 12 in a nationally representative population of over 2000 American women (Herbenick et al., 2011). Herbenick et al. (2011) have not determined a binary score for high and low FGSIS, however for the purpose of this study, a score of eight or less will indicate low FGSI, whereas more than eight will indicate high FGSI. To score eight or less, a participant must disagree with all four statements describing genital self-image therefore this is deemed to accurately represent FGSIS-4.
Through study completion, an average of 1 appointment (1 day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Manchester University NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 25, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 1, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 1, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B01328

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make IPD available to other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings