Safety and Tolerability of a Novel Implantable Neurostimulator for Ameliorate Erectile Function on Spinal Cord Injured Patients

Surgery

Sexual health

Online since 5 October 2024, updated 135 days ago

About this trial

This trial is enrolling 30 men with chronic spinal cord injury to test the effect of electrical stimulation on erectile function. If included, participants will undergo a surgical procedure to implant a device (CaverSTIM) that delivers targeted electrical stimulation to nerves that control erections (cavernous nerves in the penis). Final testing of safety, tolerability, and effectiveness of the CaverSTIM device on erectile function will be performed after 6 months.

Included participants

Gender

Male

Age

18 - 45 years

Injury level

T7 - L5

Severity (AIS)?

Time since injury

≥ 6 months

Healthy volunteers

T7-L5

Additionally, participants must

have a monogamous relationship with a female sexual partner

NOT have history of priapism or Lapeyronie's disease

History of erectile dysfunction

What’s involved

Type

Surgery

Details

- Participants will undergo a surgical procedure to implant a device (CaverSTIM) that delivers targeted electrical stimulation to the cavernous nerves. - Final testing of safety and tolerability of the CaverSTIM device will be performed after 6 months.

Potential benefits

Main benefits

Sexual health

Additional benefits

General health

Mental health and psychosocial factors

Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

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