Implantable device to treat erectile dysfunction after radical prostatectomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants undergoing nerve-sparing radical prostatectomy will receive the implantable device during their surgery or be compared with a control group who do not receive the device. The device is designed to activate pro-erectile nerves within the pelvic plexus, and implanted participants will be asked to activate it daily and measure erection hardness. All participants will attend scheduled follow-up visits and complete questionnaires over six months to monitor safety, device function, and satisfaction. Outcomes in the implanted group will be compared with the control group, with safety as the primary focus and erectile function and patient-reported satisfaction as secondary measures.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Men of ages between 30-75 years with indication for nerve-sparing prostatectomy surgery;
* Cancer stage T1c and T2a;
* Grade Groups 1 and 2 as well as low volume Grade Group 3 (Gleason score 4 + 3 = 7), as determined by biopsy (2 cores or less GG3) or single index MRI lesion of GG3 disease;
* IIEF-15 erectile function domain score equal to or greater than 26;
* Men interested in minimizing the effect of radical prostatectomy on erectile function;
* Ability to read and understand patient information materials and willingness to sign a written informed consent.

Exclusion Criteria:

* Men with neurological disease, including a history of spinal cord injury or trauma;
* IIEF-15 erectile function domain score less than 26;
* Failure to demonstrate adequate nocturne erectile function prioi prostatectomy (nocturnal RigiScan measure);
* Men with PSA \> 20 ng/mL;
* History of ED, priapism and Peyronie disease;
* History of previous pelvic surgery, trauma or irradiation therapy;
* Currently have an active implantable device.
* Patient diagnosed with neurologic degenerative diseases that may negatively impact erectile functions;
* Identification of technical or clinical limitation to properly apply the use of nerve-sparing techniques during operation;
* Inability to understand and demonstrate device use instructions;
* Patients with insulin-dependent diabetes who suffer peripheral neuropathy or other diabetes associated complications;
* Patient unwillingness to engage in sexual activity;
* Patient is currently participating in another clinical investigation that would serve as a contraindication to implant a neurostimulator device to augment erectile function;
* Have participated in any drug or device trial in the last 4 weeks or plan to participate in any other drug or device study during the next 24 months;
* Possess any other characteristics that, per the investigator's judgment, may increase the risk or impair data collection for the procedure/study;
* Patient is a member of a vulnerable population (Vulnerable participants include those who lack consent capacity, including the mentally ill, prisoners, cognitively impaired participants, and employee volunteers).

Where it's running

• Johns Hopkins Hospital
  Baltimore, Maryland, United States Recruiting

Study contacts

• Principal investigator: Christian Pavlovich, MD — Johns Hopkins University
• Study coordinator: Rana Harb
• Email: rharb1@jhmi.edu
• Phone: 410-502-5500

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Platelet-Rich Plasma for Erectile Dysfunction After Prostate Surgery

  This trial tests whether injecting a patient’s own platelet-rich plasma can improve erectile function in men who have persistent ED more than a year after nerve-sparing radical prostatectomy.

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• Multimodal Prehabilitation and Rehabilitation for Men Undergoing Robot-Assisted Prostate Surgery

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• Mobile perioperative education with video pelvic floor training after radical prostatectomy

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• New nerve surgery to help men regain erections after prostate cancer surgery

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.