‘Supported‐at‐Home’ video tuition of the trial dose of intracavernosal alprostadil

Intracavernosal injections (ICIs) are important in the management of erectile dysfunction (ED) following failure of phosphodiesterase type 5 inhibitors (PDE5i) or in patients after a non-nerve-sparing robot-assisted radical prostatectomy (RARP). The first injection is traditionally taught in a face-to-face consultation [1], and the British National Formulary states that the first dose must be given by 'medically trained personnel and self-administration may only be undertaken after proper training' [2]. This has been to reduce the risk of complications, primarily priapism, which with the typical 5 μg initial dose of alprostadil is 1% [3]. During the COVID-19 pandemic, there were extensive waiting lists to access this service. In post-RARP patients, a delay in access to the tuition clinic can have a negative impact on erectile function outcomes [4-6]. The availability of newer alprostadil injection systems such as Caverject dual chamber (Pfizer Inc., New York, NY, USA) or Viridal Duo (Advanz Pharma, London, UK) has made self-administration easier for patients, but the need for face-to-face consultations continues. The aim of this study was to assess the safety and efficacy along with acceptability of 'Supported-at-Home' video tuition of ICI alprostadil. This clinical implementation study had institutional ethical board approval. At Guy's Hospital, an instructional video was written and recorded using Viridal Duo injector (Advanz Pharma), which was used in two centres: Guy's Hospital, London and St James' Hospital, Leeds. Inclusion criteria for recruitment were failure of PDE5i; basic technical skills (able to use internet/access YouTube); and able to attend their local accident and emergency department in case of priapism. Patients were excluded if they had: penile deformity (e.g., Peyronie's disease); indwelling catheter; any patient where sexual activity was contraindicated; on anticoagulants or had any bleeding disorders; any predisposing risk to priapism (e.g., sickle cell disease); history of priapism; or concomitant use of PDE5i. Patients were enrolled following an outpatient consultation. In this consultation, patients were informed of the indications, complications and procedural aspect of ICI and screened for recruitment. If recruited, all medical equipment was posted to the patient. This included a Viridal Duo Starter Pack (Advanz Pharma) including written instructions on how to inject, instructions for the day of injection and a quick-response (QR) code/link to our instructional video. The dose to be administered was 2.5 μg. Patients should not have taken any concomitant PDE5i for 3 days up to and including the day of injection. Patients could watch the video as many times as needed prior to their injection time. A nurse specialist was available via telephone at the time of their planned injection in case any issues occurred. A total of 39 patients were recruited from the two centres. The mean (range) age was 63 (35–79) years. The aetiology was post-RARP (18/35), diabetes (five), vasculogenic (three), idiopathic ED (three), post radical cystectomy (two), following androgen-deprivation therapy (two), and post rectal cancer treatment (two). Three patients decided not to proceed following initial recruitment and changed their preference to face-to-face tuition before reviewing any materials. One patient was unable to be contacted to arrange a 'Supported-at-Home' injection appointment. Therefore, 35 patients proceeded with the trial. One further patient subsequently decided against proceeding with the 'Supported-at-Home' model after seeing the video and written information. Thirty-four (out of 35) recruits (97%) found the video instructions clear and useful, with a median (interquartile range [IQR]) score of 5 (4–5). In all, 28 (80%) found the manufacturer's written instructions useful (median [IQR] score of 4 [4–5]). Patients who proceeded to injection after video tuition, found the injection moderately, very or extremely easy to perform (median [IQR] score of 4 [3–4]). Importantly, all patients understood where to ask for help if required. The video was watched a median (IQR) of 2.5 (2–3) times prior to injecting, with only one patient (3%) requiring telephone support. In all, 32 (91%) patients found the availability of telephone support helped with confidence even though it was not used. The patients that proceeded with injection were likely to recommend the 'Supported-at-Home' method of ICI tuition. These results are summarised in Table 1. All patients had a response to 2.5 μg alprostadil ICI, with a mean (range) EHS of 1.9 (1–4). Interestingly, 10 patients achieved an EHS of 3 or 4. The majority achieved their peak EHS 11–20 min after injection. The response ranged from 0 to 90 min duration, with a mean of 32 min. On a verbal scale of pain (0–10) the mean (range) pain score was 2.2 (0–4), with the majority only feeling pain around the injection site. No pain was experienced by nine patients (26%). The median time pain was experienced was 5 min; one patient felt discomfort that lasted into the following day. Experiencing pain or discomfort would not stop any patients from utilising ICI. No patients had any significant bruising; only four had mild bruising (12%). There were no cases of priapism. This study has shown that 'Supported-at-Home' video tuition of ICI alprostadil is a safe and effective method for administrating a first trial dose. Within this study, we reduced the initial trial dose of alprostadil to 2.5 μg. This was done to further reduce the quoted 1% risk of priapism at 5 μg and we had no cases of priapism. However, 10 patients (29%) achieved an EHS of 3 or 4. This beneficial response may relate to patients being in a more comfortable environment of their own home. This would also be expected to improve following resolution of anxiety around self-injecting. With 29% patients achieving an erection adequate for penetrative intercourse, there is evidence to support the use of this reduced dose. No other significant adverse events occurred. Additionally, no patients reported severe pain that would bar them for continuing with ICI treatment. Four patients, although initially motivated to try video tuition, did not proceed with the injection appointment and this shows the importance of appropriate selection of patients for 'Supported-at-Home' video tuition. However, following recruitment only one of the 35 patients did not feel confident to proceed with injection. This shows that patients have the skills to educate themselves about simple medical procedures without direct medical supervision. Furthermore, most patients found the combination of the video and written instructions clear and useful and utilised the ability to re-watch the video several times before their injection appointment. The availability of telephone support improved confidence to proceed with self-injection, even if the support was not required. We have implemented this 'Supported-at-Home' approach into clinical practice, running alongside our face-to-face ICI tuition clinic with a single clinical nurse specialist managing both simultaneously. This has allowed an increase in the number of patients managed in a single session and has been an essential aspect of reducing the backlog of patients awaiting initiation of ICI therapy and has also allowed re-instigation of time-dependent ED therapy after RARP. This has potential to reduce the cost and improve clinical efficiency of the ED clinic. This study has shown that 'Supported-at-Home' video tuition is safe, effective, and acceptable to patients. While utilising this alongside face-to-face appointments for appropriate patients it has the potential to significantly increase productivity within clinics. No authors have relevant conflicts of interest.