Inflammatory Bowel DiseasesMenSH-IBDNCT06562751
Developing an Intervention to Help Nurses Improve Sexual Healthcare in Men With Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Diseases, run by York Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Inflammatory Bowel Disease (IBD) is a chronic, relapsing and remitting disease that can greatly impact health and personal well-being. Sexual health, relationships and intimacy have been raised as key concerns for those living with the disease. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Questionnaire, Focus group and Interview
- How many people
- 792 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Oct 2024to 22 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: As above
Who may be able to join
- A diagnosis of Crohn's Disease, Ulcerative Colitis or IBD-U who identifies as male OR Currently in (or in the last 5 years) an intimate partnership with a person who identifies as male and has a diagnosis for Crohn's Disease, Ulcerative Colitis or IBD-U.
- OR An NHS employee whose current employment involves oversight of the delivery and provision of a secondary care IBD patient service within their employing organisation. This may be a healthcare professional or non-clinical manager.
- OR A registered nurse who as part of their current role is responsible of the provision of care to patients with IBD.
- OR A health professional registered with the GMC, NMC or HCPC whose professional role is considered part of the IBD multidisciplinary team. Currently or previously employed in a role that directly provides care, support or advice to men with a diagnosis of IBD.
- OR A representative of a charitable, not-for profit, professional, public or governmental organisation that is engaged with men who suffer from long term conditions or IBD specifically.
Who cannot join
- Unable to provide informed consent Less than 18 years old Does not speak English Not able to participate in the research activity (questionnaire, interview, focus group or workshop)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing an Intervention to Help Nurses Improve the Assessment and Care of the Sexual Health Needs of Men With Inflammatory Bowel Disease: a Mixed Methods Study Using Co-production
Inflammatory Bowel Disease (IBD) is a chronic, relapsing and remitting disease that can greatly impact health and personal well-being. Sexual health, relationships and intimacy have been raised as key concerns for those living with the disease. Men's sexual health and well-being has been identified as a neglected area. This study will lead to the development of an intervention that will help nurses to improve the assessment and care of the sexual health and well-being needs of men with IBD.
Read the detailed description
This research aims to develop an intervention to help nurses improve the assessment and care of the sexual health needs of men with Inflammatory Bowel Disease (IBD). This is a long-term digestive condition that is often diagnosed between the ages of 15-30 years. Patients often have bloody diarrhoea, abdominal pain, incontinence, and fatigue.
When severe, the disease can lead to hospital admission and surgery. There is growing recognition that IBD can negatively affect sexual health and impact on patients' relationships and quality of life, but men's needs have been neglected in research. Men report that their sexual health is rarely discussed at National Health Service (NHS) IBD clinic appointments, and specialist information and support are lacking. In this study the investigators will work with men with IBD, the partners of men with IBD, nurses, and other healthcare professionals to develop a nursing intervention that addresses this unmet need through information, assessment, and support.
This study consists of three main parts which have been labelled workstreams. In Workstream One the investigators will identify how the sexual health of men with IBD is currently assessed and cared for in the NHS using three large scale surveys that will include; (1) NHS Trusts (2) Nurses (3) People with IBD.
In Workstream Two the investigators will gather ideas on appropriate ways to improve the healthcare of men with IBD by conducting interviews with men with IBD and partners of men with IBD. The investigators will also conduct focus groups with healthcare professionals to hear their ideas of how services can be improved.
In Workstream Three the investigators will hold a series of workshops with patients and healthcare professionals to develop an intervention and consider how and why it could help patients.
The design of the study has been developed with a patient advisory group and input from IBD health professionals.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Questionnaire, Focus group, Interview, Workshop
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Online questionnaire designed by the investigatory team.
Focus groupOther
Online focus group
InterviewOther
Online semi-structured interview
WorkshopOther
Online and face to face co-production workshops
| Study group | Role | What they receive |
|---|---|---|
| Survey 1 (National Health Service Inflammatory Bowel Disease services) | A survey designed by the investigators to ascertain current Inflammatory Bowel Disease service provision for sexual healthcare. A representative from each service will complete one online survey that should take approximately 15 minutes to complete. Receives: Other: Questionnaire | |
| Survey 2 (Inflammatory Bowel Disease nurses survey) | A survey designed by the investigators to ascertain current nursing practice for sexual healthcare within Inflammatory Bowel Disease (IBD) services. Registered nurses working with people with IBD will complete one online survey that should take approximately 15 minutes to complete. Receives: Other: Questionnaire | |
| Survey 3 (men with IBD) | A survey designed by the investigators to ascertain the needs of men with Inflammatory Bowel Disease (IBD). Men with a diagnosis of IBD will complete one online survey that should take approximately 15 minutes to complete. Receives: Other: Questionnaire | |
| Interviews | Men with a diagnosis of Inflammatory Bowel Disease (IBD) and the partners of men with IBD will undertake online, semi-structured interviews that will last no longer than 60 minutes. Participants can be interviewed with their partner or individually. Participants without a partner or whose partner does not wish to be interviewed will be interviewed individually. Receives: Other: Interview | |
| Focus Groups | Healthcare professionals and appropriate stakeholders (for example charitable organisations) will participate in focus groups. Each focus group will contain 6-8 members. There will be three groups in total. Receives: Other: Focus group | |
| Co-production workshops | A group of 8-12 inclusive of men with IBD, the partners of men with IBD and healthcare professionals and appropriate stakeholders will participate in three co-production workshops to develop a prototype intervention and logic model to patient benefit. Receives: Other: Workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prototype intervention
A prototype intervention to improve the assessment and care of the sexual health needs of men with Inflammatory bowel disease (IBD). The intervention will provide nurses with the improved understanding of the support and knowledge and skills required to effectively assess the sexual health needs of men with Inflammatory Bowel Disease and provide appropriate patient-centred care.
Measured: 18 months
Secondary outcomes (3)
Survey 1 outcomes:
Determine provision of sexual healthcare, assessment and support services to men with IBD in UK National Health Services including whether these differ between male and female patients.
Measured: 18 months
Survey 2 outcome
Facilitators, barriers and confidence of nurses to delivery sexual health assessment, care and advice to male patients.
Measured: 18 months
Survey 3 outcome
Perceived needs, preferences and barriers in regards to sexual health in men with Inflammatory Bowel Disease.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start17 Oct 2024
- Primary completion22 Jan 2026
- Study completion22 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 792 participants (actual)
Sponsor and investigators
- Lead sponsor
- York Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of York, York St John University, National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Sara Ma, MSc, Principal investigator, York St John University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562751
- Sponsor's protocol ID
- MenSH-IBD
- Acronym
- MenSH-IBD
- Status last verified
- Apr 2026
- First submitted
- 5 Jul 2024
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ma S, Forshaw G, Kanaan M, Knapp P, Robinson W, Selinger C, Galdas P. Developing an Intervention to Improve Sexual Health Assessment and Care in Men With Inflammatory Bowel Disease. J Adv Nurs. 2026 May;82(5):5521-5533. doi: 10.1111/jan.70199. Epub 2025 Sep 5.
PubMed 40913018
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing an Intervention to Help Nurses Improve the Assessment and Care of the Sexual Health Needs of Men With Inflammatory Bowel Disease: a Mixed Methods Study Using Co-production
- ClinicalTrials.gov ID
- NCT06562751
- Acronym / sponsor ID
- MenSH-IBD / MenSH-IBD
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 792 participants (actual)
- Lead sponsor
- York Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of York, York St John University, National Institute for Health Research, United Kingdom
- Study start
- 17 Oct 2024 (actual)
- Primary completion
- 22 Jan 2026 (actual)
- Study completion
- 22 Jan 2026 (actual)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Inflammatory Bowel Disease (IBD) is a chronic, relapsing and remitting disease that can greatly impact health and personal well-being. Sexual health, relationships and intimacy have been raised as key concerns for those living with the disease. Men's sexual health and well-being has been identified as a neglected area. This study will lead to the development of an intervention that will help nurses to improve the assessment and care of the sexual health and well-being needs of men with IBD.
Detailed description
This research aims to develop an intervention to help nurses improve the assessment and care of the sexual health needs of men with Inflammatory Bowel Disease (IBD). This is a long-term digestive condition that is often diagnosed between the ages of 15-30 years. Patients often have bloody diarrhoea, abdominal pain, incontinence, and fatigue.
When severe, the disease can lead to hospital admission and surgery. There is growing recognition that IBD can negatively affect sexual health and impact on patients' relationships and quality of life, but men's needs have been neglected in research. Men report that their sexual health is rarely discussed at National Health Service (NHS) IBD clinic appointments, and specialist information and support are lacking. In this study the investigators will work with men with IBD, the partners of men with IBD, nurses, and other healthcare professionals to develop a nursing intervention that addresses this unmet need through information, assessment, and support.
This study consists of three main parts which have been labelled workstreams. In Workstream One the investigators will identify how the sexual health of men with IBD is currently assessed and cared for in the NHS using three large scale surveys that will include; (1) NHS Trusts (2) Nurses (3) People with IBD.
In Workstream Two the investigators will gather ideas on appropriate ways to improve the healthcare of men with IBD by conducting interviews with men with IBD and partners of men with IBD. The investigators will also conduct focus groups with healthcare professionals to hear their ideas of how services can be improved.
In Workstream Three the investigators will hold a series of workshops with patients and healthcare professionals to develop an intervention and consider how and why it could help patients.
The design of the study has been developed with a patient advisory group and input from IBD health professionals.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Survey 1 (National Health Service Inflammatory Bowel Disease services) | – | Other: QuestionnaireA survey designed by the investigators to ascertain current Inflammatory Bowel Disease service provision for sexual healthcare. A representative from each service will complete one online survey that should take approximately 15 minutes to complete. |
| Survey 2 (Inflammatory Bowel Disease nurses survey) | – | Other: QuestionnaireA survey designed by the investigators to ascertain current nursing practice for sexual healthcare within Inflammatory Bowel Disease (IBD) services. Registered nurses working with people with IBD will complete one online survey that should take approximately 15 minutes to complete. |
| Survey 3 (men with IBD) | – | Other: QuestionnaireA survey designed by the investigators to ascertain the needs of men with Inflammatory Bowel Disease (IBD). Men with a diagnosis of IBD will complete one online survey that should take approximately 15 minutes to complete. |
| Interviews | – | Other: InterviewMen with a diagnosis of Inflammatory Bowel Disease (IBD) and the partners of men with IBD will undertake online, semi-structured interviews that will last no longer than 60 minutes. Participants can be interviewed with their partner or individually. Participants without a partner or whose partner does not wish to be interviewed will be interviewed individually. |
| Focus Groups | – | Other: Focus groupHealthcare professionals and appropriate stakeholders (for example charitable organisations) will participate in focus groups. Each focus group will contain 6-8 members. There will be three groups in total. |
| Co-production workshops | – | Other: WorkshopA group of 8-12 inclusive of men with IBD, the partners of men with IBD and healthcare professionals and appropriate stakeholders will participate in three co-production workshops to develop a prototype intervention and logic model to patient benefit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- As above
Key inclusion criteria (5 listed)
- A diagnosis of Crohn's Disease, Ulcerative Colitis or IBD-U who identifies as male OR Currently in (or in the last 5 years) an intimate partnership with a person who identifies as male and has a diagnosis for Crohn's Disease, Ulcerative Colitis or IBD-U.
- OR An NHS employee whose current employment involves oversight of the delivery and provision of a secondary care IBD patient service within their employing organisation. This may be a healthcare professional or non-clinical manager.
- OR A registered nurse who as part of their current role is responsible of the provision of care to patients with IBD.
- OR A health professional registered with the GMC, NMC or HCPC whose professional role is considered part of the IBD multidisciplinary team. Currently or previously employed in a role that directly provides care, support or advice to men with a diagnosis of IBD.
- OR A representative of a charitable, not-for profit, professional, public or governmental organisation that is engaged with men who suffer from long term conditions or IBD specifically.
Key exclusion criteria (1 listed)
- Unable to provide informed consent Less than 18 years old Does not speak English Not able to participate in the research activity (questionnaire, interview, focus group or workshop)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireOnline questionnaire designed by the investigatory team. | Other | Survey 1 (National Health Service Inflammatory Bowel Disease services), Survey 2 (Inflammatory Bowel Disease nurses survey), Survey 3 (men with IBD) |
| Focus groupOnline focus group | Other | Focus Groups |
| InterviewOnline semi-structured interview | Other | Interviews |
| WorkshopOnline and face to face co-production workshops | Other | Co-production workshops |
Primary outcome
Prototype intervention
Time frame: 18 months
A prototype intervention to improve the assessment and care of the sexual health needs of men with Inflammatory bowel disease (IBD). The intervention will provide nurses with the improved understanding of the support and knowledge and skills required to effectively assess the sexual health needs of men with Inflammatory Bowel Disease and provide appropriate patient-centred care.
3 secondary outcomes
Survey 1 outcomes:
Time frame: 18 months
Survey 2 outcome
Time frame: 18 months
Survey 3 outcome
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Derived from this study: PubMed 40913018Ma S, Forshaw G, Kanaan M, Knapp P, Robinson W, Selinger C, Galdas P. Developing an Intervention to Improve Sexual Health Assessment and Care in Men With Inflammatory Bowel Disease. J Adv Nurs. 2026 May;82(5):5521-5533. doi: 10.1111/jan.70199. Epub 2025 Sep 5.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Ma, MSc principal investigator
York St John University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by York Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prototype intervention (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06562751, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.