Randomised controlled trial comparing the clinical and cost-effectiveness of various washout policies versus no washout policy in preventing catheter associated complications in adults living with long-term catheters: study protocol for the CATHETER II study.

BACKGROUND: Various washout policies are widely used in adults living with long-term catheters (LTC). There is currently insufficient evidence on the benefits and potential harms of prophylactic LTC washout policies in the prevention of blockages and other LTC-related adverse events, such as urinary tract infections. CATHETER II tests the hypothesis that weekly prophylactic LTC washouts (normal saline or citric acid) in addition to standard LTC care reduce the incidence of catheter blockage requiring intervention compared to standard LTC care only in adults living with LTC. METHODS: CATHETER II is a pragmatic three-arm open multi-centre superiority randomised controlled trial with an internal pilot, economic analysis, and embedded qualitative study. Eligible participants are adults aged ≥ 18 years, who have had a LTC in use for ≥ 28 days, have no plans to discontinue the use of the catheter, are able to undertake the catheter washouts, and complete trial documentation or have a carer able to help them. Participants are identified from general practitioner practices, secondary/tertiary care, community healthcare, care homes, and via public advertising strategies. Participants are randomised 1:1:1 to receive a weekly saline (0.9%) washout in addition to standard LTC care, a weekly citric acid (3.23%) washout in addition to standard LTC care or standard LTC care only. Participants and/or carers will receive training to administer the washouts. Patient-reported outcomes are collected at baseline and for 24 months post-randomisation. The primary clinical outcome is catheter blockage requiring intervention up to 24 months post-randomisation expressed per 1000 catheter days. Secondary outcomes include symptomatic catheter-associated urinary tract infection requiring antibiotics, catheter change, adverse events, NHS/ healthcare use, and impact on quality of life. DISCUSSION: This study will guide treatment decision-making and clinical practice guidelines regarding the effectiveness of various prophylactic catheter washout policies in men and women living with LTC. This research has received ethical approval from Wales Research Ethics Committee 6 (19/WA/0015). TRIAL REGISTRATION: ISRCTN ISRCTN17116445 . Registered prospectively on 06 November 2019.

Assessment of the introduction of an adolescent transition urology clinic using a validated questionnaire.

BACKGROUND: Adolescents with complex urological conditions are at risk of bladder dysfunction, metabolic disturbances, neoplastic changes and deterioration in renal function. Hence they require appropriate transition to the adult service to ensure lifelong urological care is adequately provided. OBJECTIVE: Barriers and difficulties to the transition process have been identified in the literature. To overcome these difficulties an Adolescent Transition Urology Clinic (ATUC) was established in 2009 where the patients are seen by a paediatric and an adult urologist, a urology nurse and if needed an adolescent gynaecologist. Our aim was to assess the ATUC and present the patient's perspective to this new service using a validated questionnaire. MATERIALS AND METHODS: Data of all patients seen at the ATUC over the study period were prospectively recorded. Patients who completed the transition were contacted and asked to complete two online urological transition questionnaires: 1) The Care Transition Measure 15 (CTM-15) which is a validated questionnaire to assess the quality of care during transition from the patients' perspective. 2) The Transition Care Experience (TCE) which was created for the purpose of this study. RESULTS: Thirty patients attended the ATUC over 4.5 years, with 26 (87%) completing the transition to the adult urological care. Of the 26 patients there were 14 (54%) males with a mean age of 18 years. The most common underlying urological condition was neurogenic bladder (85%). Nineteen (73%) patients completed the questionnaires. Only 1 (5%) patient thought that attending the ATUC was not beneficial, 17 (89%) would recommend the ATUC to other adolescents and 9 (47%) patients considered 18 as the appropriate transition age. Overall, 74% thought that written information would have been useful and 21% considered the adult hospital as an inappropriate environment for young adults. After attending the ATUC, 2 (11%) patients thought their preferences were not met and 3 (16%) patients were not confident that they can take care of their health. DISCUSSION: Transition of patients with complex urological conditions should aim to facilitate transferring the care from the parent to the patient and preparing the adolescent to adult life by addressing their sexual and reproductive functions. Inadequate transition can have serious health consequences. On-going communication between the paediatric and the adult urologist facilitates the transition process even after the transfer of care has occurred. The CTM-15 has been considered as "the only available measure of quality of care during transition from the patients' perspective". Our study suggests that the large majority of adolescent attending the clinic are confident in looking after their complex urological condition. In addition one patient in 5 found the adult hospital environment an inappropriate place for adolescents and they would have preferred longer follow up in a children's hospital. The value of written information after clinic consultation seems to be a useful adjunct that might facilitate the complex transition process. CONCLUSION: This is the first report evaluating the transition of adolescents with complex urological conditions using a validated transition questionnaire. The combined paediatric/adult urology clinic is beneficial in addressing the patients' needs and allowing smooth transition of these complex patients to the adult service.