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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether adding a special type of ultrasound, called ultrasound vibroelastography (UVE), can better assess erectile function recovery after prostate cancer surgery. Researchers aim to determine if this noninvasive technique provides more information than standard ultrasound alone. Men diagnosed with localized prostate cancer, who have mild or no erectile dysfunction, and are planning prostate removal surgery might be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance post-surgery recovery assessments.

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 prior data suggests that this ultrasound technique is safe for evaluating erectile function recovery?

Research has shown that ultrasound vibroelastography (UVE) is a promising tool for diagnosing erectile dysfunction (ED). UVE is non-invasive, meaning it doesn't involve surgery or entering the body. It has been safely used to assess tissue health by measuring stiffness or flexibility.

Studies have found that people generally tolerate this method well, with most reporting no significant pain or side effects. Although detailed information on negative effects is limited, its non-invasive nature suggests a low risk of harm. This makes it an appealing option for those considering participation in a clinical trial using this type of ultrasound.

Consulting a healthcare provider is crucial to understand the implications of joining a trial and to determine if it is the right choice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Ultrasound Vibroelastography (UVE) for erectile dysfunction because it offers a non-invasive alternative that could enhance recovery after prostate surgery. Traditional treatments, like medications or injections, primarily address symptoms without directly aiding tissue recovery. UVE works differently by using sound waves to assess and potentially improve the elasticity and function of penile tissues post-surgery. This innovative approach could provide more precise insights into recovery progress and ultimately support better rehabilitation outcomes.

What evidence suggests that ultrasound vibroelastography is effective for assessing erectile function recovery after prostate cancer surgery?

Research has shown that ultrasound vibroelastography (UVE) can help assess erectile dysfunction (ED). This technique measures tissue stiffness, revealing changes in the penis that lead to ED. Studies have found that UVE can detect tissue differences that other methods might miss. This trial will evaluate UVE in patients undergoing radical prostatectomy for prostate cancer to predict how well a patient might regain erectile function after surgery. Early findings suggest that combining UVE with standard ultrasound methods might provide a clearer picture of erectile health. ^{2 4 6 7 8}

Who Is on the Research Team?

Matthew J. Ziegelmann, M.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S009042951830102X

A Novel Noninvasive Ultrasound Vibro-elastography ... Male Sexual Dysfunction. A Novel Noninvasive Ultrasound Vibro-elastography Technique for Assessing Patients With Erectile Dysfunction and Peyronie Disease.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10063753/

Comparison of preoperative penile elastographic ... Erectile dysfunction (ED) is defined as the inability to maintain an adequate erection to achieve satisfactory sexual performance and maintain an erection [2].

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/and.14359

Role of shear wave elastography (SWE) in erectile ... Another study suggested that SWE help in the diagnosis of erectile dysfunction (ED), regardless of aetiology (Turkay et al., 2017). On reviewing ...

4. arxiv.org arxiv.org/pdf/1806.00415

A Numerical Study of the Relationship Between Erectile ... Erectile dysfunction (ED) is defined as the inability to achieve and/or maintain an erection satisfactory for penetrative sexual intercourse. Although.

5. researchgate.net researchgate.net/publication/379175843_Ultrasound_Elastography_as_a_Diagnostic_Tool_for_Peyronie's_Disease_A_State-of-the-Art_Review

(PDF) Ultrasound Elastography as a Diagnostic Tool for ... both PD and erectile dysfunction (ED), and two with isolated ED [. 41. ]. Ultrasound vibro-. elastography was performed. The main objectives of ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1751616119307933

A pilot patient study and its correlation with penile ... The ratio of collagen to smooth muscle often increases in men with ED, resulting in corporal fibrosis, and eventual veno-occlusive dysfunction (Mulhallet al., ...

7. siemens1313.github.io siemens1313.github.io/assets/pdf/2018-penile-urology.pdf

2018-penile-urology.pdf - Boran Zhou ED, erectile dysfunction; EF, erectile function; IIEF-EFD, International Index of Erectile Function-Erectile Function Domain; OR, odds ratio;.

8. researchgate.net researchgate.net/topic/Erectile-Dysfunction~Doppler-Ultrasonography/publications

Erectile Dysfunction and Doppler Ultrasonography This study sought to investigate the correlation between Helicobacter pylori (Hp) and arteriogenic erectile dysfunction (ED). This study included 30 patients ...