Protocol for a pilot randomised controlled trial to evaluate integrated support from pharmacist independent prescriber and third sector worker for people experiencing homelessness: the PHOENIx community pharmacy study.

BACKGROUND: People experiencing homelessness (PEH) have complex health and social care needs and most die in their early 40 s. PEH frequently use community pharmacies; however, evaluation of the delivery of structured, integrated, holistic health and social care intervention has not been previously undertaken in community pharmacies for PEH. PHOENIx (Pharmacy Homeless Outreach Engagement Non-medical Independent prescribing Rx) has been delivered and tested in Glasgow, Scotland, by NHS pharmacist independent prescribers and third sector homelessness support workers offering health and social care intervention in low threshold homeless drop-in venues, emergency accommodation and emergency departments, to PEH. Building on this work, this study aims to test recruitment, retention, intervention adherence and fidelity of community pharmacy-based PHOENIx intervention. METHODS: Randomised, multi-centre, open, parallel-group external pilot trial. A total of 100 PEH aged 18 years and over will be recruited from community pharmacies in Glasgow and Birmingham. PHOENIx intervention includes structured assessment in the community pharmacy of health, housing, benefits and activities, in addition to usual care, through weekly visits lasting up to six months. A primary outcome is whether to proceed to a definitive trial based on pre-specified progression criteria. Secondary outcomes include drug/alcohol treatment uptake and treatment retention; overdose rates; mortality and time to death; prison/criminal justice encounters; healthcare utilisation; housing tenure; patient-reported measures and intervention acceptability. Analysis will include descriptive statistics of recruitment and retention rates. Process evaluation will be conducted using Normalisation Process Theory. Health, social care and personal resource use data will be identified, measured and valued. DISCUSSION: If the findings of this pilot study suggest progression to a definitive trial, and if the definitive trial offers positive outcomes, it is intended that PHOENIx will be a publicly funded free-to-access service in community pharmacy for PEH. The study results will be shared with wider stakeholders and patients in addition to dissemination through medical journals and scientific conferences. TRIAL REGISTRATION: International Clinical Trial Registration ISRCTN88146807. Approved protocol version 2.0 dated July 19, 2022.

Management of refractory overactive bladder in children by transcutaneous posterior tibial nerve stimulation: A controlled study.

OBJECTIVE: To assess the objective efficacy of transcutaneous posterior tibial nerve stimulation in children presenting with overactive bladder resistant to well conducted treatment. MATERIAL AND METHOD: This was a randomized, double-blind, controlled study on 20 children with OAB. All patients were previously treated with anticholinergic drugs associated with detrusor rehabilitation, diet advice, bladder-voiding hygiene and constipation treatment, with poor clinical results. Patients were randomized into two groups: -Group A: treatment with PTNS (n = 11). -Group B: sham treatment (n = 9). The program lasted 12 consecutive weeks with two 30-minutes sessions a week. Each patient underwent pre-stimulation urodynamic testing to validate bladder overactivity followed by a post-stimulation testing. Pre- and post-stimulation urodynamic parameters were compared in order to objectively evaluate the treatment's efficacy. The patients noted their incontinence episodes for 7 consecutive days in a diary before the beginning of the program, in the middle and at the end of it: this led to computing an incontinence score (score ranged from 0 to 13, from good to poor). The difference between the pre-stimulation and post-stimulation score enabled to express clinical results in terms of poor (less than a 3-point decrease), medium (a 3 to 5-point decrease), good (6 to 8-point decrease), very good (final score ranged between 0 and 3). Children were questioned regarding their impression of being stimulated or not. RESULTS: In Group A, there were five very good clinical results (45%), one medium (10%) and five poor results (45%). In group B, nine very good results (66%) and three poor results (33%) were noted. Regarding urodynamic testing, volume voided during urgency (184 mL to 265 mL), maximal cystomanometry volume (215 mL to 274 mL) and volume at the onset of the first overactive detrusor contraction (ODC) (48 mL to 174 mL) were significantly increased in Group A (p = 0.002, p = 0.024 and p = 0.001) and maximal bladder pressure during ODC had decreased (61 to 46) (p = 0.042). 85% children in group A thought they were being stimulated vs. 70% in group B. CONCLUSION: Even though we noticed urodynamics improvements in group A, which objectively supports the efficacy of TCTPNS, clinical results remained the same between the two groups. In spite of the small size of our sample, this underlines the placebo effect of any type management in this pediatric population. Studying precisely the maximal useful voltage and duration of stimulation should then be relevant in order to yield maximal benefits from this easy-to-use procedure.

Botulinum toxin injections in the management of non-neurogenic overactive bladders in children.

INTRODUCTION: Non-neurogenic detrusor overactivity in children leads to varying degrees of functional impairments (urinary urgency, pollakiuria, urge incontinence, nocturia). Botulinum toxin has shown its effectiveness in the management of detrusor overactivity in neurological patients. OBJECTIVES: To evaluate the relevance of intravesical Botulinum toxin injections for the treatment of non-neurogenic overactive bladders in children. These pediatric patients were resistant to all the usual therapeutics (e.g. bladder/bowel rehabilitation, anticholinergic drugs, management of diet/hygiene habits and constipation, percutaneous posterior tibial nerve stimulation). MATERIALS AND METHODS: 8 children (mean age: 12.5years), 5 girls, 3 boys with daytime and/or nighttime incontinence and non-neurogenic detrusor overactivity validated by urodynamic testing. Urodynamic testing was conducted before the injections as well as 6weeks and 1year post injections. We used Dysport® 8 Speywood Units/kg injected via cystoscopy into 25 different sites. RESULTS: We noted improvements without any complaints during bladder voiding for all patients, in 6 patients the overactivity disappeared after 1 injection. Compliance was improved early-on in half the cases and at 1year for all cases (from 12% to 61%, p=0.01). Noninhibited contractions decreased constantly in both frequency and intensity. Clinical symptoms improved: mean of 7.75 daytime urinary incontinence episodes (IE) per week before the injection vs. 3 after the procedure (p=0.04). For nighttime IE the improvement was even more noticeable with 7.38 nighttime IE episodes per week before the injection vs. 2.06 after the procedure (p=0,02). CONCLUSION: Intradetrusor Botulinum toxin injections are a potential therapeutic option for the management of non-neurogenic detrusor overactivity in children resistant to the usual treatments.