Baltimore, MDNCT06968494Now EnrollingIRB Ready

Erectile Dysfunction Following Radical Prostatectomy Clinical Trial in Baltimore, MD

Access cutting-edge erectile dysfunction following radical prostatectomy treatment through this clinical trial at a research site in Baltimore. Study-provided care at no cost to qualified participants.

Sponsored by Comphya Inc.

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Expert Care in Baltimore

Access erectile dysfunction following radical prostatectomy specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related erectile dysfunction following radical prostatectomy treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to Baltimore

    Convenient for MD residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Baltimore site if eligible
  4. 4Begin participation

About This Erectile Dysfunction Following Radical Prostatectomy Study in Baltimore

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: * Is the device safe? * Does the device works well? Are the participants satisfied with the device? 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: * Come to the hospital for follow-up visits, * Complete questionnaires, * Activate the device every day, * Measure erection hardness. 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.

Sponsor: Comphya Inc.

Who Can Participate

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).

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Baltimore?

Yes, this clinical trial (NCT06968494) has an active research site in Baltimore, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Erectile Dysfunction Following Radical Prostatectomy Treatment Options in Baltimore, MD

If you're searching for erectile dysfunction following radical prostatectomy treatment options in Baltimore, MD, this clinical trial (NCT06968494) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Baltimore research site is actively enrolling participants for this clinical trial. You'll receive care from experienced erectile dysfunction following radical prostatectomy specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all erectile dysfunction following radical prostatectomy clinical trials near you to find additional studies recruiting in your area.

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