Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implanted group | Experimental | Participants in the implanted group will be implanted with the study device during ongoing prostatectomy surgery. |
|
| 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 pro-erectile nerves by delivering electrical pulses. The daily delivery of electrical pulses to the pro-erectile nerves may allow participants to recover natural erectile function. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of adverse events | Adverse events will be systematically reported. | 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 assessment | Participants will be asked to rate pain on a visual analog scale (from 0 to 10) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Device Effectiveness | Device effectiveness will be assessed by asking participants to complete validated questionnaires. | 6 months |
| Erectile function rehabilitation | Nocturnal penile erections will be assessed with the RigiScan device. Nocturnal erections reflect the extent of rehabilitation of natural erectile function. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Gender eligibility: male. Not based on self-representation of gender identity.
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rana Harb | Contact | 410-502-5500 | rharb1@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Christian Pavlovich, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Recruiting | Baltimore | Maryland | 21287 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 6 months |
| Duration of Surgical Implantation Procedure | Time (in minutes) from initial implant placement to final suture of the implant. | During surgical procedure |
| Ease of Implantation Steps | Surgeon-reported rating of the ease of each implantation step using a standardized ordinal scale. | During surgical procedure |