Ultrasound for Erectile Dysfunction

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Androgen deprivation

Disqualifiers: Moderate ED, Prior pelvic surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

10 Participants Needed

Trial Summary

What is the purpose of this trial?

Researchers are trying to determine whether there is additional utility to using vibroelastography, a noninvasive ultrasound technique to evaluate for the presence of tissue fibrosis, in conjunction with standard penile duplex Doppler ultrasound to assess erectile function (recovery) after prostate cancer surgery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Ultrasound Vibroelastography (UVE) for erectile dysfunction?

The research does not provide direct evidence of the effectiveness of Ultrasound Vibroelastography (UVE) for treating erectile dysfunction, but it does explore the use of similar ultrasound techniques like shear wave elastography (SWE) for diagnosing erectile dysfunction, suggesting potential diagnostic benefits. ^{1 2 3 4 5}

Is ultrasound treatment generally safe for humans?

Ultrasound treatments, including those using contrast agents, are generally safe for humans. Most side effects are mild and temporary, such as tenderness or redness, and serious reactions are rare. Proper technique is important to minimize risks. ^{6 7 8 9 10}

How is the treatment Ultrasound Vibroelastography (UVE) unique for erectile dysfunction?

Ultrasound Vibroelastography (UVE) is unique because it uses a noninvasive ultrasound technique to assess the stiffness of tissues, which can help diagnose and potentially treat erectile dysfunction by providing detailed information about the penile tissue's condition without the need for invasive procedures. ^{1 3 5 11 12}

Research Team

Matthew J. Ziegelmann, M.D.

Principal Investigator

Mayo Clinic

Eligibility Criteria

Men over 40 with early-stage prostate cancer (low to intermediate risk) and mild or no erectile dysfunction, as measured by a score of ≥21 on the IIEF. They must be interested in preserving sexual function and planning to undergo nerve-sparing prostatectomy surgery.

Inclusion Criteria

I want to consult about preserving or improving my sexual function.

International Index of Erectile Function (IIEF) of ≥ 21 points at baseline (no or mild erectile dysfunction)

I am scheduled for a prostate surgery that spares the nerves.

Exclusion Criteria

I have undergone hormone therapy for cancer.

Moderate or severe ED based on IIEF criteria (score < 21)

I am scheduled for a prostate surgery that does not preserve nerves.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgery Assessment

Ultrasound vibroelastography performed before surgery to establish baseline viscoelasticity

1 week

1 visit (in-person)

Post-surgery Monitoring

Ultrasound vibroelastography performed at 3, 6, and 9 months post-prostatectomy to assess changes in viscoelasticity

9 months

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the main assessment period

3 months

Treatment Details

Interventions

• Ultrasound Vibroelastography (UVE)

Trial Overview The trial is testing Ultrasound Vibroelastography (UVE), a noninvasive technique, alongside standard penile duplex Doppler ultrasound to see if it better assesses erectile function recovery after prostate cancer surgery.

Participant Groups

Group I: Ultrasound viscoelastography (UVE) in radical proctectomy recovery Experimental Treatment 1 Intervention

Subjects undergoing radical prostatectomy for prostate cancer disease as standard of care will have a ultrasound vibroelastography performed before surgery, 3 months, 6 months and 9 months post-prostatectomy.

Ultrasound Vibroelastography (UVE) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Ultrasound Vibroelastography for:

• Assessment of erectile function recovery after prostate cancer surgery
• Evaluation of tissue fibrosis

Approved in European Union as Vibroelastography for:

• Assessment of erectile function recovery after prostate cancer surgery
• Evaluation of tissue fibrosis

Approved in Canada as Ultrasound Elastography for:

• Assessment of erectile function recovery after prostate cancer surgery
• Evaluation of tissue fibrosis

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

In a study of 43 patients with erectile dysfunction, contrast-enhanced ultrasonography (CEUS) accurately diagnosed 21 out of 23 cases of corpus cavernosal venous leakage (CCVL), demonstrating its effectiveness in identifying this condition.

CEUS is a safe and less invasive diagnostic tool for venous erectile dysfunction, providing a reliable alternative to more invasive procedures like corpus cavernography.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Contrast-enhanced ultrasonography in the diagnosis of venous erectile dysfunction]. Gao, QQ., Jin, ZB., Shi, L., et al.[2022]

Shear wave elastography (SWE) demonstrated a significant difference in measurements between men with erectile dysfunction (ED) and healthy volunteers, indicating its potential as a diagnostic tool for ED.

With a cut-off value of 17.1 kPa, SWE showed high specificity (94.29%) and positive predictive value (85.71%) for diagnosing ED, suggesting it could be a reliable method in clinical evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shear wave elastography: Can it be a new radiologic approach for the diagnosis of erectile dysfunction? Turkay, R., Inci, E., Yenice, MG., et al.[2022]

A novel method using ultrasonic shear wave elastography (SWE) was developed to predict arteriogenic erectile dysfunction (AED) in 98 male patients, showing a strong correlation between SWE measurements and erectile function.

SWE demonstrated high sensitivity (89.6%) and specificity (78.6%) in distinguishing AED from healthy subjects, suggesting it could be a non-invasive alternative to the traditional penile Doppler ultrasonography for diagnosing erectile dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of shear wave elastography measured in the flaccid state in predicting arteriogenic erectile dysfunction. Zhang, Y., Zhou, W., Wu, X., et al.[2021]

In a study of 45 patients with erectile dysfunction (ED), color Doppler ultrasonography (CDUS) effectively differentiated between vasculogenic and non-vasculogenic causes of ED, with significant findings in nocturnal penile tumescence (NPT) rates among different groups.

Nocturnal electrobioimpedance volumetric assessment (NEVA) showed a strong correlation with CDUS results, particularly indicating that NEVA can help identify the underlying causes of ED, especially noting lower blood volume changes in the venogenic ED group compared to non-vasculogenic ED.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comparison study on the diagnosis of erectile dysfunction with color Doppler ultrasonography and nocturnal electrobioimpedance volumetric assessment]. Li, JB., Huang, DZ., Rao, K., et al.[2016]

In a study of 215 patients with erectile dysfunction (ED), pharmacocolor-coded duplex sonography (PHCCDS) effectively assessed both arterial flow and venous leakage, revealing critical hemodynamic information necessary for understanding ED.

The results indicated that PHCCDS can identify specific blood flow patterns in the penile arteries and veins, making it a valuable tool for diagnosing ED, while suggesting that additional tests like pharmacocavernosometry and -graphy (PHCM and PHCG) are only needed for patients considering surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of the penile vascular system with color-coded duplex sonography and pharmacocavernosometry and -graphy in impotent men. Andresen, R., Wegner, HE.[2019]

Ultrasound contrast agents are generally safe for clinical use, with serious adverse reactions being rare and most adverse events being minor and self-resolving, such as headache and nausea.

The Contrast Media Safety Committee found that while intolerance to some components can occur, generalized allergy-like reactions are infrequent, emphasizing the overall well-tolerated nature of these agents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of ultrasound contrast agents. Jakobsen, JA., Oyen, R., Thomsen, HS., et al.[2020]

Contrast-enhanced ultrasound (CEUS) using the approved agent Lumason has a highly favorable safety profile in pediatric patients, with serious adverse events occurring in only 0.22% of children across 4,518 examinations.

The majority of adverse events related to CEUS were non-serious, with a low incidence rate of 1.20%, indicating that CEUS is a safe imaging option for evaluating conditions in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contrast-enhanced ultrasound: a comprehensive review of safety in children. Ntoulia, A., Anupindi, SA., Back, SJ., et al.[2021]

Microfocused Ultrasound with Visualization (MFU-V) has a well-established safety profile, showing only mild and transient side effects like tenderness and redness, with rare adverse events typically linked to improper technique.

When used correctly, MFU-V treatments are safe, with most side effects resolving quickly and without lasting effects, indicating its efficacy in cosmetic dermatology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of the safety profile for microfocused ultrasound with visualization. Hitchcock, TM., Dobke, MK.[2022]

The survey highlights current opinions on the safety of diagnostic ultrasound applications, indicating a need for ongoing evaluation of its safety profile.

The paper outlines specific labeling requirements for ultrasound equipment as proposed by the Netherlands' Committee on the Safety of Ultrasound, emphasizing the importance of clear communication regarding output levels and potential adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic ultrasound equipment. Safety and dosimetry. Thijssen, JM., van Beekum, WT., Daniëls, O., et al.[2005]

In a study involving 23,188 abdominal examinations using the ultrasound contrast agent SonoVue, only 29 adverse events (AEs) were reported, indicating a very low incidence of complications.

The overall rate of serious adverse events was extremely low at 0.0086%, and SonoVue demonstrated a good safety profile, comparable to or better than other contrast agents used in radiology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of Sonovue in abdominal applications: retrospective analysis of 23188 investigations. Piscaglia, F., Bolondi, L.[2022]

Ultrasonic velocitometry (UV) is as accurate as duplex ultrasonography (DU) for measuring peak flow velocities in the cavernous artery, based on a study of 24 patients who underwent both tests after receiving papaverine.

The new fixed-angle UV device is a safe and easier-to-learn alternative to DU, making it a promising option for assessing penile arterial hemodynamics in an office setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of penile ultrasonic velocitometry versus penile duplex ultrasonography to assess penile arterial hemodynamics. Knoll, LD., Abrams, JH.[2019]

Ultrasound examination, including B-scan, Duplex scan, and Doppler color imaging, is an effective diagnostic tool for identifying various causes of erectile dysfunction in 70 patients, allowing for a detailed assessment of penile morphology and blood flow.

The findings from these ultrasound techniques can guide tailored treatment strategies, particularly for patients considering revascularization procedures, and improve monitoring for those undergoing self-injection therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The value of corpus cavernosum sonography following administration of vasoactive substances in the diagnosis of patients with erectile impotence]. Derouet, H., Steffens, J., Scheffler, P., et al.[2015]

References

1. China pubmed.ncbi.nlm.nih.gov

[Contrast-enhanced ultrasonography in the diagnosis of venous erectile dysfunction]. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Shear wave elastography: Can it be a new radiologic approach for the diagnosis of erectile dysfunction? [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Role of shear wave elastography measured in the flaccid state in predicting arteriogenic erectile dysfunction. [2021]

4. China pubmed.ncbi.nlm.nih.gov

[Comparison study on the diagnosis of erectile dysfunction with color Doppler ultrasonography and nocturnal electrobioimpedance volumetric assessment]. [2016]

5. England pubmed.ncbi.nlm.nih.gov

Assessment of the penile vascular system with color-coded duplex sonography and pharmacocavernosometry and -graphy in impotent men. [2019]

6. Germany pubmed.ncbi.nlm.nih.gov

Safety of ultrasound contrast agents. [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

Contrast-enhanced ultrasound: a comprehensive review of safety in children. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Review of the safety profile for microfocused ultrasound with visualization. [2022]

9. Ireland pubmed.ncbi.nlm.nih.gov

Diagnostic ultrasound equipment. Safety and dosimetry. [2005]

10. England pubmed.ncbi.nlm.nih.gov

The safety of Sonovue in abdominal applications: retrospective analysis of 23188 investigations. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Evaluation of penile ultrasonic velocitometry versus penile duplex ultrasonography to assess penile arterial hemodynamics. [2019]

12. Germany pubmed.ncbi.nlm.nih.gov

[The value of corpus cavernosum sonography following administration of vasoactive substances in the diagnosis of patients with erectile impotence]. [2015]