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The goal of this clinical trial is to assess if a new device is safe to use as a potential treatment for erectile dysfunction following radical prostatectomy.
The main questions it aims to answer are:
Participants will be implanted with the device during the ongoing prostatectomy surgery and will be asked to complete the following tasks during 6 months follow-up:
Researchers will compare an implanted group (participants having the device) with a control group (participants not having the device) to see if the device works well.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implanted group | Experimental | The study device will be implanted during the ongoing prostatectomy surgery. Participants will then be asked to activate it everyday. |
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| Control group | No Intervention | Participants in the control group will undergo standard prostatectomy and will not be implanted with the study device. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activation of pro-erectile nerves within the pelvic plexus | Device | The study device is an active implantable device. The device activates the cavernous nerves by delivering electrical pulses, to trigger an on-demand erection. The daily delivery of electrical pulses to the cavernous nerves will also allow participants to recover natural erectile function. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of adverse events | Adverse events will be reported using MedDRA terminology. | 6 months |
| Occurrence of surgical complications | Surgical complications will be ranked according to the Clavien-Dindo classification | 6 months |
| Occurrence of device deficiencies | Device deficiencies will be systematically reported and recorded. | 6 months |
| Pain | Patients will be asked to rate pain on a visual analog scale (from 0 to 10) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Device effectiveness | Erectile response obtained when activating the study device will be objectively assessed by measuring penile rigidity with the RigiScan device. | 6 months |
| Subjective Device effectiveness |
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Inclusion Criteria:
Exclusion Criteria:
Gender eligibility: male. Not based on self-representation of gender identity.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Helen Crowe | Contact | +61 3 8373 7600 | helenrcrowe@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Vincent's Private Hospital | Active, not recruiting | Fitzroy | Victoria | 3065 | Australia | |
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Erectile function will be subjectively assessed by asking participants to complete validated questionnaires (International Index of Erectile Function, IIEF-15 and Erection Hardness Score, EHS).
| 6 months |
| Erectile function recovery | Nocturnal penile erections will be assessed with the RigiScan device. Nocturnal erections reflect the extent of recovery of natural erectile function. | 6 months |
| Delineation of the surgical implantation procedure | The surgeon will record information related to the implantation (duration, position of the device, grading ease of implantation steps, and any comments). | 6 months |
| Royal Melbourne Hospital |
| Active, not recruiting |
| Melbourne |
| Victoria |
| 3050 |
| Australia |
| Australian Prostate Centre | Recruiting | North Melbourne | Victoria | 3051 | Australia |
|
| Epworth HealthCare | Active, not recruiting | Richmond | Victoria | 3121 | Australia |