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Trial registered on ANZCTR


Registration number
ACTRN12624000477527
Ethics application status
Approved
Date submitted
14/11/2023
Date registered
18/04/2024
Date last updated
18/04/2024
Date data sharing statement initially provided
18/04/2024
Date results provided
18/04/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical trial assessing penile prosthesis implant recovery care
Scientific title
A randomised, controlled trial on the concept of ERIC (Enhanced Recovery Implant Care) in clinical outcomes and patient satisfaction rates following inflatable penile prosthesis implantation
Secondary ID [1] 310962 0
Nil unknown
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Erectile dysfunction 332044 0
Penile prosthesis implant 332045 0
Condition category
Condition code
Surgery 328770 328770 0 0
Other surgery
Renal and Urogenital 328771 328771 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study evaluates the concept of ERIC (Enhanced Recovery Implant Care) on clinical outcomes and patient satisfaction rates following inflatable penile prosthesis (IPP) surgery.
The concept of ERIC includes strict intraoperative and postoperative care to maximise patient comfort and minimise surgical bruising (strict perioperative analgesic regime of intra-operative nerve block and device drug elution use, meticulous haemostatic closure and fitted scrotal care following IPP surgery). Professor Eric Chung is the principal supervisor/investigator for this trial. The setting for this trial is undertaken at various hospitals (Princess Alexandra Hospital, Greenslopes Private Hospital and St Andrew's War Memorial Hospital) with the involvement of the AndroUrology Centre. The intervention was performed over 12 months. Monitoring of intervention was carried out by an independent third party.
Perioperative analgesia regime consists of the following combination of oral medications - Oxycodone 5mg four times a day as required, tapentadol 100mg four times a day as required and NSAID (ibuprofen 400mg twice daily) for 7 days postoperatively. All patients complete a drug chart to document the intake of analgesia.
Meticulous hemostasis consists of water-tight closure of corporotomies, use of Surgicel fibrillar hemostat and 2-layer dartos closure of the scrotum.
The perioperative regime is administered by a nurse on day 0 of surgery and patients will take the necessary analgesia once discharged from the hospital.
Intervention code [1] 327393 0
Treatment: Surgery
Comparator / control treatment
The control group receives normal care. There will be no specific perioperative analgesic regime and additional haemostatic closure and fitted scrotal care following IPP surgery (compared to the ERIC group).
Normal care is lack of proper water-tight closure of corporotomies and, use of Surgicel fibrillar hemostat in the wound.
Control group
Active

Outcomes
Primary outcome [1] 336579 0
Objective measurement of multiple pain scores based on visual analogue scale (VAS)
Assessment method [1] 336579 0
Validated VAS score (this validated questionnaire is widely used in pain score)
Timepoint [1] 336579 0
Day 1, 7, 14, 28 (primary endpoint) and 42 postoperatively.
Primary outcome [2] 336997 0
Time to IPP cycling of the device
Assessment method [2] 336997 0
Ease of comfort to cycle device. Normally, the device is cycled at 6 weeks postoperatively. Still, in this study, we will see patients at 2, 4 and 6 weeks early postoperative period. So, we will determine if the patient can cycle the device earlier than the traditional 6-week postoperative period. Patients will complete data relating to the ease of comfort to the cycle device using the study-specific questionnaire.
Timepoint [2] 336997 0
Day 14, 28 (primary endpoint) and 42 postoperatively.
Primary outcome [3] 337701 0
Analgesic requirement (opioid dose equivalence).
Assessment method [3] 337701 0
Conversion of opioid dose equivalence using the study-specific questionnaire.
Timepoint [3] 337701 0
Day 1, 7, 14, 28 (primary endpoint) and 42 postoperatively.
Secondary outcome [1] 428848 0
Patient satisfaction rate.
Assessment method [1] 428848 0
validated 5-point patient satisfaction scale
Timepoint [1] 428848 0
Day 1, 7, 14, 28 and 42 postoperatively.
Secondary outcome [2] 431831 0
Intraoperative complications
Assessment method [2] 431831 0
Any reported intraoperative complications (blood transfusion or device damage) were obtained from hospital records and patient self-reporting using the study-specific questionnaire.
Timepoint [2] 431831 0
Intraoperative complications will be collected at the time of surgery Patients will be asked to self-report any complications in the 72-hour post-operative period

Eligibility
Key inclusion criteria
Males with age 21 to 80 years
Patients with erectile dysfunction who are keen on penile prosthesis implant
Minimum age
21 Years
Maximum age
80 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Concurrent penile reconstructive surgery
Unable to provide informed consent
Not wanting or unable to have penile prosthesis implant

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)
Randomisation of patients was conducted through central randomisation using a computer system and allocation involved contacting the holder of the allocation schedule who was “off-site”.
The surgeon is blinded to the clinical outcomes since an independent third party collects the data. Patients were randomised to receive ERIC vs normal care pathways with computer-generated numbers ( 1 for ERIC and 2 for normal care).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation
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/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/03/2021
Date of last participant enrolment
Anticipated
Actual
11/12/2021
Date of last data collection
Anticipated
Actual
14/05/2022
Sample size
Target
62
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 315219 0
Hospital
Name [1] 315219 0
Androurology Centre
Country [1] 315219 0
Australia
Primary sponsor type
Hospital
Name
Androurology Centre
Country
Australia
Secondary sponsor category [1] 317252 0
None
Name [1] 317252 0
Country [1] 317252 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314143 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 314143 0
Ethics committee country [1] 314143 0
Australia
Date submitted for ethics approval [1] 314143 0
18/01/2021
Approval date [1] 314143 0
08/02/2021
Ethics approval number [1] 314143 0

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 130570 0
Prof Eric Chung
Address 130570 0
AndroUrology Centre, Suite 3, 530 Boundary St. Spring Hill QLD 4000
Country 130570 0
Australia
Phone 130570 0
+61738321168
Fax 130570 0
+61-7-38328889
Email 130570 0
ericchg@hotmail.com
Contact person for public queries
Name 130571 0
Eric Chung
Address 130571 0
AndroUrology Centre, Suite 3, 530 Boundary St. Spring Hill QLD 4000
Country 130571 0
Australia
Phone 130571 0
+61738321168
Fax 130571 0
+61-7-38328889
Email 130571 0
ericchg@hotmail.com
Contact person for scientific queries
Name 130572 0
Eric Chung
Address 130572 0
AndroUrology Centre, Suite 3, 530 Boundary St. Spring Hill QLD 4000
Country 130572 0
Australia
Phone 130572 0
+61738321168
Fax 130572 0
+61-7-38328889
Email 130572 0
ericchg@hotmail.com

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Case-by-case basis at the discretion of the Primary Sponsor

Conditions for requesting access:
• -

What individual participant data might be shared?
• all of the individual participant data of primary and secondary outcomes

What types of analyses could be done with individual participant data?
• Only to achieve the aims in the approved proposal

When can requests for individual participant data be made (start and end dates)?
From:
Currently available with no end date determined

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Principal Investigator via email request on androurology@gmail.com or via post to AndroUrology Centre, Suite 3, 530 Boundary St. Spring Hill QLD 4000.

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20903Study protocol  ericchg@hotmail.com Study-related document.docx



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.