Electro-acupuncture for recovery of erectile function after Robotic Assisted Radical Prostatectomy in Prostate Cancer patients: A feasibility study and randomised controlled trial.
- Conditions
- Erectile dysfunctionProstate CancerCancer - ProstateAlternative and Complementary Medicine - Other alternative and complementary medicineRenal and Urogenital - Other renal and urogenital disorders
- Registration Number
- ACTRN12621000886886
- Lead Sponsor
- Western Sydney University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 72
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
Applicants will be excluded from the study if they have:
•Demand-type pacemakers;
•Any metal implantable devices in the pelvic region or penile prosthesis;
• 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method