Using ultrasound to assess erectile dysfunction after prostate cancer surgery
Ultrasound Vibroelastography in Post-Prostatectomy Erectile Dysfunction
This study is testing a new ultrasound method to see if it can help men recover their erectile function after prostate cancer surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 40 Years and up |
| Sex | Male |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT05109208 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of vibroelastography, a noninvasive ultrasound technique, in evaluating tissue fibrosis alongside standard penile duplex Doppler ultrasound to assess erectile function recovery in patients who have undergone radical prostatectomy for prostate cancer. The goal is to determine if this combined approach provides additional insights into erectile dysfunction recovery. Participants will be monitored for their erectile function post-surgery to evaluate the utility of this method.
Who should consider this trial
Good fit: Ideal candidates are men over 40 with localized prostate cancer who are scheduled for nerve-sparing prostatectomy and have mild erectile dysfunction.
Not a fit: Patients with moderate to severe erectile dysfunction or those who have had prior pelvic or penile surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the assessment and management of erectile dysfunction in men recovering from prostate cancer surgery.
How similar studies have performed: While the use of ultrasound techniques in assessing erectile function is established, the specific combination of vibroelastography with standard methods is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria include: * Age \> 40 years * Clinically localized prostate cancer (American Urological Association Grade Groups 1-2; cT1c or cT2a-b; PSA \< 10) without clinic or imaging evidence of localized extra-prostatic or metastatic disease (i.e. AUA low and favorable intermediate risk prostate cancer) * International Index of Erectile Function (IIEF) of ≥ 21 points at baseline (no or mild erectile dysfunction) * Patient-expressed interest in consultation for sexual function (erectile function) preservation/ optimization * Planned bilateral nerves-paring prostatectomy Exclusion criteria include: * Moderate or severe ED based in IIEF criteria (score \< 21) * History of prior pelvic or penile surgery * Current or prior androgen deprivation therapy * Planned non-nerve sparing prostatectomy
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Matthew J. Ziegelmann, M.D. — Mayo Clinic
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.