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Clinical trial assessing penile prosthesis implant recovery care

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000477527
Enrollment
60
Registered
2024-04-18
Start date
2021-03-05
Completion date
2021-12-11
Last updated
2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Enhanced Recovery After Surgery (ERAS) has been accepted as a standard of care designed to achieve early recovery and reduce stress response following surgery. While penile prosthesis implantation is a safe and effective treatment for males with erectile dysfunction, it is not without complications including postoperative pain and scrotal hematoma. This study evaluates the concept of ERIC (Enhanced Recovery Implant Care) on clinical outcomes and patient satisfaction rates following inflatable penile prosthesis (IPP) surgery. ERIC pathway appears to improve clinical outcomes and postoperative recovery following IPP surgery in terms of pain score, the analgesic requirement, and time to IPP cycling, as well as the overall patient satisfaction rate.

Interventions

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). Professo

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.

Sponsors

Androurology Centre
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
Male
Age
21 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

Males with age 21 to 80 years Patients with erectile dysfunction who are keen on penile prosthesis implant

Exclusion criteria

Concurrent penile reconstructive surgery Unable to provide informed consent Not wanting or unable to have penile prosthesis implant

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026