Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000886886
Ethics application status
Approved
Date submitted
10/02/2021
Date registered
8/07/2021
Date last updated
2/11/2022
Date data sharing statement initially provided
8/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Electro-acupuncture for recovery of erectile function after Robotic Assisted Radical Prostatectomy in Prostate Cancer patients: A feasibility study and randomised controlled trial.
Scientific title
Electro-acupuncture for improving erectile dysfunction after Robotic Assisted Radical Prostatectomy: A randomized controlled trial and feasibility and acceptability study.
Secondary ID [1] 303340 0
Nil
Universal Trial Number (UTN)
Trial acronym
EDY study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Erectile dysfunction 320622 0
Prostate Cancer 321157 0
Condition category
Condition code
Cancer 318477 318477 0 0
Prostate
Alternative and Complementary Medicine 318956 318956 0 0
Other alternative and complementary medicine
Renal and Urogenital 318957 318957 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 319671 0
Treatment: Devices
Comparator / control treatment
Group B - The usual care group is the control group. Group B is defined continuing with their 'usual care' medication and/or use of erection rehabilitation devices but group B does not not receive the intervention.
Participants in Group B will be required to complete the same questionnaires via a secure online email link. Group B will be offered the intervention treatment at completion of the trial if it is shown to have some benefit.
Control group
Active

Outcomes
Primary outcome [1] 326440 0
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.
Timepoint [1] 326440 0
After close of recruitment.
Primary outcome [2] 326882 0
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.
Timepoint [2] 326882 0
Completion of the study week 9.
Primary outcome [3] 326883 0
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.
Timepoint [3] 326883 0
After close of recruitment
Secondary outcome [1] 391497 0
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.
Timepoint [1] 391497 0
At close of recruitment
Secondary outcome [2] 392968 0
Primary outcome
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.
Timepoint [2] 392968 0
After close of recruitment
Secondary outcome [3] 392969 0
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 .
Timepoint [3] 392969 0
At completion of the study after week 9 post commencement of the intervention.
Secondary outcome [4] 392970 0
Primary outcome
Adverse events: Safety of the intervention will be assessed by noting all adverse events on the assessment log.
Timepoint [4] 392970 0
At completion of the study after week 9.
Secondary outcome [5] 392971 0
Changes in erectile function as measured by the IIEF - 5.
Timepoint [5] 392971 0
Weeks 1, 5 and 9.
Secondary outcome [6] 392972 0
Changes in erectile function as measured by the EHS.
Timepoint [6] 392972 0
Weeks 1, 5 and 9.
Secondary outcome [7] 392973 0
Changes in erectile function as measured by the EPIC.
Timepoint [7] 392973 0
Weeks 1, 5 and 9.
Secondary outcome [8] 392974 0
Anxiety - measured by the MAX - PC
Timepoint [8] 392974 0
Weeks 1, 5 and 9.
Secondary outcome [9] 392975 0
Credibility and acceptability measured by the credibility and acceptability questionnaire
Timepoint [9] 392975 0
Prior to the first intervention treatment week 1 and after completion of the intervention week 9.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised into 2 groups: one being the intervention and the other being usual care. The sequence generation of participants to either the intervention or control (usual care) will be undertaken using a computer random number generator (Research Randomizer: https://www.randomizer.org/).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
Sample sizes will consist of 2 groups of 30 men per arm of the trial which is sufficient to determine numbers for a larger trial (Billingham et al., 2013); this requires a recruitments number of 72, for a dropout rate of 20%.

Key trial parameters of screening, eligibility, consent, recruitment rate, intervention adherence and adverse events will be presented as descriptive statistics. We used ANOVA to identify between-group differences, adjusting for baseline score as a co-variate. Where data was not normally distributed, we used non-parametric measures (Mann-Whitney U tests). Intention-to-treat analysis was used. Analysis and interpretation of the findings was conducted by blinded investigators. Investigators agreed on the interpretation of the findings before revealing the allocation of either group. At the time of interpretation of findings, the two groups were only referred to as “Group 1” or “Group 2”. Group numbers were also not revealed as this could have compromised blinding.

Thematic analysis will be used for the data in the open ended comments box (Braun & Clarke, 2006).
Secondary objectives: Changes in erectile function as measured by the IIEF-5/SHIM, EHS and EPIC.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2022
Actual
1/08/2022
Date of last participant enrolment
Anticipated
1/08/2023
Actual
Date of last data collection
Anticipated
1/08/2023
Actual
Sample size
Target
72
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18580 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment hospital [2] 18581 0
Sydney Adventist Hospital - Wahroonga
Recruitment postcode(s) [1] 32954 0
2050 - Camperdown
Recruitment postcode(s) [2] 32955 0
2076 - Wahroonga

Funding & Sponsors
Funding source category [1] 307757 0
University
Name [1] 307757 0
Western Sydney University
Country [1] 307757 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
NICM Health Research Institute
158-160 Hawkesbury Rd,
Westmead NSW, 2145
Country
Australia
Secondary sponsor category [1] 308486 0
None
Name [1] 308486 0
Address [1] 308486 0
Country [1] 308486 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307778 0
Adventist Healthcare Ltd Human Research Ethics Comittee
Ethics committee address [1] 307778 0
Ethics committee country [1] 307778 0
Australia
Date submitted for ethics approval [1] 307778 0
21/10/2020
Approval date [1] 307778 0
14/12/2020
Ethics approval number [1] 307778 0
2020-040
Ethics committee name [2] 308970 0
St Vincent's Hospital
Ethics committee address [2] 308970 0
Ethics committee country [2] 308970 0
Australia
Date submitted for ethics approval [2] 308970 0
03/06/2021
Approval date [2] 308970 0
30/06/2021
Ethics approval number [2] 308970 0
2021/ETH00033

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108466 0
Dr Suzanne Grant
Address 108466 0

NICM Health Research Institute
Western Sydney University
Marcus Blackmore building J
158-160 Hawkesbury rd
Westmead
NSW 2145
Country 108466 0
Australia
Phone 108466 0
+61 419126209
Fax 108466 0
Email 108466 0
[email protected]
Contact person for public queries
Name 108467 0
Emma Wong
Address 108467 0
Emma Wong
NICM Health Research Institute
Western Sydney University
Marcus Blackmore building J
158-160 Hawkesbury rd
Westmead
NSW 2145
Country 108467 0
Australia
Phone 108467 0
+61 421021124
Fax 108467 0
Email 108467 0
[email protected]
Contact person for scientific queries
Name 108468 0
Emma Wong
Address 108468 0
Emma Wong
NICM Health Research Institute
Western Sydney University
Marcus Blackmore building J
158-160 Hawkesbury rd
Westmead
NSW 2145
Country 108468 0
Australia
Phone 108468 0
+61 421021124
Fax 108468 0
Email 108468 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data on the feasibility of the intervention and changes in erectile function scores will be shared after anaylsis.
When will data be available (start and end dates)?
Following publication with no end date decided
Available to whom?
The data will be available to the public via publication.
Available for what types of analyses?
None specific
How or where can data be obtained?
Unrestricted access via free publication


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10549Statistical analysis plan    This will be available after publication



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.