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Completed

NCT Number: NCT06562751

Developing an Intervention to Help Nurses Improve Sexual Healthcare in Men With Inflammatory Bowel Disease

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Sarah Ma

York, North Yorkshire, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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)

Treatment and study plan

Questionnaire

Other

Online questionnaire designed by the investigatory team.

Focus Group

Other

Online focus group

interview

Other

Online semi-structured interview

Workshop

Other

Online and face to face co-production workshops

Primary outcomes

  1. 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.

Secondary outcomes

  1. Survey 1 outcomes:

    Time frame: 18 months

    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.

  2. Survey 2 outcome

    Time frame: 18 months

    Facilitators, barriers and confidence of nurses to delivery sexual health assessment, care and advice to male patients.

  3. Survey 3 outcome

    Time frame: 18 months

    Perceived needs, preferences and barriers in regards to sexual health in men with Inflammatory Bowel Disease.

Sponsors and collaborators

Lead sponsor

York Teaching Hospitals NHS Foundation Trust

Other

Collaborators

  • National Institute for Health Research, United Kingdom
  • University of York
  • York St John University

Registry information

Official study 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

Acronym: MenSH-IBD

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 20, 2024
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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