None listed
Conditions
Brief summary
This study will investigate the feasibility, acceptability and effect of electroacupuncture on erectile dysfunction after robotic assisted radical prostatectomy in prostate cancer patients Who is it for? You may be eligible to join this study if you are over 18 and have undergone robotic assisted radical prostatectomy > 6 weeks ago and <=24 months ago and experience erectile dysfunction as a result of the surgery. Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants group A will receive an electroacupuncture intervention for 10 visits over 8 weeks. Participants group B will continue with their usual care which may include medications and use of devices. Feasibility and acceptability of the intervention will be assessed by recording key trial parameters of screening, eligibility, consent, recruitment rate, intervention adherence and adverse events. Erectile function will be assessed using questionnaires. It is hoped that this research project will provide more information on whether electroacupuncture could be another treatment option for erectile dysfunction after radical prostatectomy which would improve the lives of many men.
Interventions
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
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 anatomy of the acupuncture point. Each session will be 40 minutes, and the needles in situ for 20 mins. The intervention can be administered >6 weeks and <24 months after robotic assisted radical prostatectomy. Participants attendance and compliance will be recorded under the primary feasibility objective of retention and intervention adherence. Attendance and compliance is recorded on the assessment log
Sponsors
Western Sydney University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
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. • 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.
Exclusion criteria
EXCLUSION CRITERIA Applicants will be excluded from the study if they have: • Demand-type pacemakers; • Any metal implantable devices in the pelvic region or penile prosthesis; • Nil nerve spare; • Participants with a history of a psychological illness or a mental illness that may impair their ability to consent; • Participants with morbid obesity (BMI index >40); • People with a cognitive impairment, an intellectual disability; • Needle phobia; • Are on anticoagulants other than aspirin; • Enrolled in other investigational studies that have the potential to impact on erectile function; • Had previous acupuncture or electroacupuncture for potency recovery.
Outcome results
None listed