Electro-acupuncture for recovery of erectile function after Robotic Assisted Radical Prostatectomy in Prostate Cancer patients: A feasibility study and randomised controlled trial.

INTERVENTION: Electroacupuncture for recovery of erectile function after robotic assisted radical prostatectomy: A feasibility study and randomised controlled trial. Standardised Protocol INTERVENTION GROUP A Participants in Group A (intervention) will be required to attend 10 visits over 8 weeks. 2 visits in the first 2 weeks and then 1 visit each week until the 8 weeks is complete. Scores are filled out week 1, 5 and the final scores are filled out in week 9. The credibility and acceptability questionnaire consist of 2 questions prior to treatment and 2 questions on completion of treatment. The first visit is the enrolment visit and treatment session will take 60 minutes. Each subsequent treatment visit will take 40 minutes. Group B (usual care) will fill out the scores remotely at week 1, 5 and 9. The scores for both groups will take approximately 10 minutes. A standardised protocol will be administered. Participants will receive 15 acupuncture points at each session. The selection of these points is based on traditional acupuncture point function as per Deadman (Deadman, Al‐Khafaji, & Baker, 1998) and anatomically local points. The intervention session will take 40 minutes. The patient will be positioned prone on the treatment table and asked to disrobe down to underwear and they will be covered with a towel. After a brief explanation of the intervention, the acupuncturist delivering the intervention will insert the acupuncture needles. The person delivering the intervention is a registered acupuncturist with over 15 years clinical experience. The needles will be retained in situ for a minimum of 20 minutes. Single use disposable stainless steel needles with gauge 0.20 x 25 mm and 0.22 x 40 mm. Needle size has been chosen due to suitability to the a CONDITION: Alternative and Complementary Medicine ‐ Other alternative and complementary medicine Cancer ‐ Prostate Erectile dysfunction;Prostate Cancer; ; Erectile dysfunction ; Prostate Cancer Renal and Urogenital ‐ Other renal and urogenital disorders SECONDARY OUTCOME: Anxiety ‐ measured by the MAX ‐ PC[Weeks 1, 5 and 9.] Changes in erectile function as measured by the EHS.[Weeks 1, 5 and 9.] Changes in erectile function as measured by the EPIC.[Weeks 1, 5 and 9.] Changes in erectile function as measured by the IIEF ‐ 5. [Weeks 1, 5 and 9.] Credibility and acceptability measured by the credibility and acceptability questionnaire[Prior to the first intervention treatment week 1 and after completion of the intervention week 9.] Primary outcome ; Adverse events: Safety of the intervention will be assessed by noting all adverse events on the assessment log. [At completion of the study after week 9.] Primary outcome ; Consent: The consent rate will be recorded by dividing the number of eligible participants by the number who agree to be part of the study. Reasons for not consenting will be noted. The percentage conversion measured as n eligible participants/ n consenting participants. the data will be collected from the study PICF. ; ; [At close of recruitment ; ; ] Primary outcome ; Intervention adherence: Adherence will be measured dividing the total number of participants starting the trial to those completing the intervention. Reasons for not completing the trial will be noted in both group A and group B. The data will be collected from the study with withdrawals noted on the assessment log .[At completion of the study after week 9 post commencement of the intervention.] Primary outcome INCLUSION CRITERIA: INCLUSION CRITERIA Inclusion criteria are: • Male; • >18 years • Have undergone Robotic assisted radical prostatectomy <=24 months ago with some nerve spare defined by the urologist as either unilateral, bilateral or partial nerve spare. PRIMARY OUTCOME: Acceptability: Acceptability will be measured by the survey and the open ended comments box for collecting qualitative data. The survey has been developed specifically for the study.[Completion of the study week 9. ] Eligibility: The eligibility rates will be determined by dividing the number of males who met the inclusion/exclusion criteria and those that didn’t and noting the reasons for not being eligible. The data will be collected from the study from the screening survey.[After close of recruitment ] To investigate feasibility and acceptability we will record and assess the following key trial parameters of screening, eligibility, consent, recruitment rate, intervention adherence and adverse events independently. Screening: The screening rate is defined as the number of males who had undergone a radical prostatectomy with unilateral or bilateral nerve spare and were deemed acceptable to the trial after meeting the inclusion/exclusion criteria. Acceptance or decline rates will be noted. This data is collected from the study from the screening log and enrolment.; ; ; ; ; ; ; ; [After close of recruitment.; ; ; ; ; ] ; Recruitment: Recruitment is measured by number of inquiries and enrolments per month of active recruitment. The percentage conversion to enrolments measured as n enrolled/ n enquiries and n enrolled/ n potentially eligible. ; Individual sources of recruitment will also be recorded, and each source then converted to a percentage of total enrolled. Percentage n of each source/ n total enrolled. Number of inquiries and clicks will be recorded from any ads and engagement rate will be generated as a percentage. The data will be collected from the study screening survey and collected from online advertising sources.[After close of recruitment] • Evidence of clear margins from the treating urologist • Continent defined as no pads or incontinent defined as either 1 pad per day or 2 or more pads per day • Deemed fully functional regarding potency prior to surgery via pre‐operative IIEF 5/SHIM score from urologist or via participant feedback • Have disclosed all medication including PDE5s, use of VED and injectable medications and do not alter the medication/standard care regime for the duration of the study • Willingness to provide informed consent and willingness to participate and comply with the study requirements.