Selective dorsal rhizotomy (SDR) is one of the treatment options available for spasticity management in ambulatory children and young people with cerebral palsy (CYPwCP). Although improvements in gross motor function one to two years after surgery have been established, evidence of longer-term benefit requires further investigation. Given the irreversible nature of SDR and the increased rehabilitation commitments required from families and clinicians, providing evidence of longer-term benefits is essential to support their decision-making. This study aims to investigate medium (3–5 years) and long-term (6–10 years) SDR outcomes in ambulatory children with CP and how SDR affects families’ lives over time.

This is a convergent parallel mixed-methods study using the International Classification of Functioning, Disability and Health as a theoretical framework. The study aims to recruit 90 CYPwCP participants, who had SDR at a tertiary hospital in the UK when aged between 3 and 14 years. Participants (parents and CYPwCP) will be invited to complete an online survey and attend the hospital for one follow-up visit 3 or more years after SDR. Comparisons will be made with existing data on objective measures and parent-reported outcomes collected in clinical practice at baseline, 6, 12 and 24 months to understand the trajectory of changes. Semistructured interviews will be conducted with 18–20 parents/carers and 25–30 CYPwCP to understand their perspectives on the outcomes of SDR compared with their prior expectations. The Framework Method will be used to analyse qualitative data both inductively and deductively. Qualitative and quantitative study data will be integrated using joint displays.

Ethical approval has been obtained through the Coventry and Warwick Research and Ethics Committee (24/WM/0078). Findings will be shared through international conferences, peer-reviewed journals, social media and dissemination events for families and CYP.

NCT06518889.

The ageing population in Europe is experiencing a significant rise in urinary incontinence (UI), which affects millions and incurs substantial healthcare costs. While conservative treatment (eg, behavioural strategies, pelvic floor exercises) can help manage UI, there is a need for evidence-based eHealth solutions to improve adherence and treatment outcomes. The KOKU Bladder project aims to co-create, develop and test an eHealth intervention to improve bladder health (BH) and UI in adults aged 50 and over.

Phase 1 will consist of the co-creation and technological development of the eHealth solution. First, a rapid review will be undertaken to identify eHealth solutions (ie, technologies and websites), including behaviour change techniques (BCTs) and elements of gamification for self-management of BH and UI in adults aged 50 and over. Also, a consultation with eight experts on BH/UI and/or BCTs will be conducted to explore recommendations for the new eHealth solution. The PROSECO framework will facilitate an assessment of the co-creation process. Phase 1 will additionally include the conduction of at least six focus groups, to be held in Kaunas (Lithuania), Catalonia (Spain) and Manchester (UK) to co-create the contents of the digital solution. Each focus group will include 10–12 community-dwelling adults aged 50+, with different physical conditions and continence status, as well as health professionals and other stakeholders. The information collected will be analysed thematically. First, we will hold three focus groups, one in each country, to find out the opinion of the participants. Once the focus groups are finished and the first version of the technological solution is created, participants will test it and provide feedback in three additional focus groups. Participants’ opinions will be taken into account to make modifications to the solution and co-create the final version. Gamification methods and the Honeycomb model for user experience will be followed in order to achieve a technological solution that is adequate for its target population.

Phase 2 will consist of a multicentre pilot study with a mixed method (quantitative and qualitative) approach to assess the feasibility and acceptability of the newly developed technological solution. At least 120 participants (40 per country) will be recruited and randomised into two groups: intervention (KOKU Bladder) and control (indirect health education). The primary outcome will be the severity of UI, according to the International Consultation on Incontinence Questionnaire-UI short form. Secondary outcomes will include quality of life (EuroQol 5-Dimension, 5-Level), life-impact related to UI (Incontinence Impact Questionnaire-7), lower urinary tract symptoms (Symptoms of Lower Urinary Tract Dysfunction Research Network Symptom Index-10 (LURN SI-10)), International Consultation Questionnaire on Incontinence Bowel Score, Patient Global Impression of Improvement; levels of physical activity and sedentary behaviour (accelerometer), as well as satisfaction with treatment (Client Satisfaction Questionnaire (CSQ-8)). The latter, together with recruitment, adherence, retention, attrition and data loss, will be used for measuring intervention feasibility and acceptability. Statistical and clinical significance, as well as effect size, will be calculated.

The project is approved by the Research Ethics Committee of IRIS-CC approved the project on 9 January 2025 (code 24/095), the Research Ethics Committee of Hospital Universitari Arnau de Vilanova of Lleida on 27 January 2025 (CEIC-3201), the Commission on Research Ethics of Lithuania on 3 March 2025 (SMTEK-31) and the Research Ethics Committee 3 of the University of Manchester on 13 August 2025 (2025-23619-43258). Participation and withdrawal will be voluntary. Informed consent will be obtained from candidates willing to join the project. Study results will be disseminated via publication of scientific articles, presentations at professional workshops, webinars and congresses, as well as through social media and lay summaries for participants and the general public.

NCT06583733.

CRD42024597624.