Ultrasound for Erectile Dysfunction
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Mayo Clinic
Must not be taking: Androgen deprivation
Disqualifiers: Moderate ED, Prior pelvic surgery, others
No Placebo Group
Approved in 3 Jurisdictions
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.
12345Is 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.
678910How 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.
1351112Eligibility 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.
+2 more
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.
+1 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Ultrasound viscoelastography (UVE) in radical proctectomy recoveryExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo Clinic in RochesterRochester, MN
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Who Is Running the Clinical Trial?
Mayo ClinicLead Sponsor
References
[Contrast-enhanced ultrasonography in the diagnosis of venous erectile dysfunction]. [2022]To investigate the effect and safety of contrast-enhanced ultrasonography (CEUS) in the diagnosis of venous erectile dysfunction (VED).
Shear wave elastography: Can it be a new radiologic approach for the diagnosis of erectile dysfunction? [2022]Erectile dysfunction (ED) is a common health problem among males, and radiology has limited use in its diagnosis and treatment. Shear wave elastography (SWE) is a new sonographic technique. In this study, we examined the significance of SWE in the diagnosis of ED.
Role of shear wave elastography measured in the flaccid state in predicting arteriogenic erectile dysfunction. [2021]The gold-standard method for diagnosing arteriogenic erectile dysfunction (AED) is the penile Doppler ultrasonography. We proposed a novel method for predicting AED using ultrasonic shear wave elastography (SWE) considering that the former was invasive and variable. A total of 98 male patients were enrolled in our study, referred for ED between December 2018 and October 2020. For comparison, we also included 42 volunteers from the Healthy Physical Examination Center of our hospital. The Penile Doppler Ultrasonography (PDU) and SWE were performed for all patients with the intracavernosal injection (ICI). We named three groups as AED group, nonvascular ED group and healthy controls group. No statistically significant differences were found among the three groups in terms of demographic and clinical characteristics. There were no significant differences in IIEF-5 between AED and nonvascular ED. A significant (r = 0.642, p
[Comparison study on the diagnosis of erectile dysfunction with color Doppler ultrasonography and nocturnal electrobioimpedance volumetric assessment]. [2016]To study the diagnostic value of color Doppler ultrasonography(CDUS) and nocturnal electrobioimpedance volumetric assessment (NEVA) in the assessment of erectile dysfunction (ED) and in differentiating the causes of ED.
Assessment of the penile vascular system with color-coded duplex sonography and pharmacocavernosometry and -graphy in impotent men. [2019]To examine the extent to which color-coded duplex sonography permits complete clarification of vessel-dependent erectile dysfunction (ED).
Safety of ultrasound contrast agents. [2020]The use of ultrasound contrast agents has increased over recent years. The Contrast Media Safety Committee (CMSC) of the European Society of Urogenital Radiology (ESUR) decided to review the safety of ultrasound contrast agents in humans and to draw up guidelines. A comprehensive literature search and review was carried out. The resulting report was discussed by the CMSC of ESUR and at the 11th European Symposium on Urogenital Radiology in Santiago de Compostela, Spain, in 2004. Ultrasound contrast agents approved for clinical use are well tolerated, and serious adverse reactions are rarely observed. Adverse events are usually minor (e.g. headache, nausea, altered taste, sensation of heat) and self-resolving. These symptoms may not be related to the ultrasound contrast materials as they have also been observed in placebo-control groups. Intolerance to some components may occur. Generalized allergy-like reactions occur rarely. Ultrasound contrast agents are generally safe. The ultrasound scanning time and the acoustic output should be kept to the lowest level consistent with obtaining diagnostic information. Adverse reactions should be treated symptomatically.
Contrast-enhanced ultrasound: a comprehensive review of safety in children. [2021]Contrast-enhanced ultrasound (CEUS) has been increasingly used in pediatric radiology practice worldwide. For nearly two decades, CEUS applications have been performed with the off-label use of gas-containing second-generation ultrasound contrast agents (UCAs). Since 2016, the United States Food and Drug Administration (FDA) has approved the UCA Lumason for three pediatric indications: the evaluation of focal liver lesions and echocardiography via intravenous administration and the assessment of vesicoureteral reflux via intravesical application (contrast-enhanced voiding urosonography, ceVUS). Prior to the FDA approval of Lumason, numerous studies with the use of second-generation UCAs had been conducted in adults and children. Comprehensive protocols for clinical safety evaluations have demonstrated the highly favorable safety profile of UCA for intravenous, intravesical and other intracavitary uses. The safety data on CEUS continue to accumulate as this imaging modality is increasingly utilized in clinical settings worldwide. As of August 2021, 57 pediatric-only original research studies encompassing a total of 4,518 children with 4,906 intravenous CEUS examinations had been published. As in adults, there were a few adverse events; the majority of these were non-serious, although very rarely serious anaphylactic reactions were reported. In the published pediatric-only intravenous CEUS studies included in our analysis, the overall incidence rate of serious adverse events was 0.22% (10/4,518) of children and 0.20% (10/4,906) of all CEUS examinations. Non-serious adverse events from the intravenous CEUS were observed in 1.20% (54/4,518) of children and 1.10% (54/4,906) of CEUS examinations. During the same time period, 31 studies with the intravesical use of UCA were conducted in 12,362 children. A few non-serious adverse events were encountered (0.31%; 38/12,362), but these were most likely attributable to the bladder catheterization rather than the UCA. Other developing clinical applications of UCA in children, including intracavitary and intralymphatic, are ongoing. To date, no serious adverse events have been reported with these applications. This article reviews the existing pediatric CEUS literature and provides an overview of safety-related information reported from UCA uses in children.
Review of the safety profile for microfocused ultrasound with visualization. [2022]The Safety of Microfocused Ultrasound with Visualization (MFU-V) has been well established in both controlled clinical studies and in clinical use, showing only mild and transient anticipated side effects and only rare unanticipated adverse events (AEs). This publication discusses the safety profile of MFU-V based on data from a variety of sources. Reports of side effects and AEs were obtained from published peer-reviewed medical literature, clinical studies, in-market use reports (AEs reported to the manufacturer), and retrospective chart reviews of patient treatments. Events that were typical included tenderness, redness, and slight edema. Rare events included bruising, welting, and nerve-related effects (paresthesia and paresis). Rare incidence of surface thermal effects was seen in some cases where improper technique was used. In all cases where the device was uses properly, the safety events reported tended to be transient, mild in nature, and resolved without sequelae. In general, unexpected and rare AEs could be attributed to incorrect treatment technique or classified as unrelated to MFU-V treatment. Side effects that do occur are generally mild and transient in nature. MFU-V consistently allows for safe treatment when correct treatment technique is used.
Diagnostic ultrasound equipment. Safety and dosimetry. [2005]A survey of present opinions on the safety of diagnostic ultrasound applications is presented together with some data on output levels. Physical mechanisms involved in potential adverse effects are described. Labelling requirements of the equipment are defined and specified. These requirements are contained in a recent proposal of the Netherlands' Committee on the Safety of Ultrasound.
The safety of Sonovue in abdominal applications: retrospective analysis of 23188 investigations. [2022]The aim of the present retrospective study was to assess the incidence of adverse events (AE) of a second-generation ultrasound contrast agent in real clinical practice. A total of 28 Italian Centres provided data on the postmarketing use of SonoVue (Bracco Spa, Milan, Italy) in abdominal examination performed between December 2001 and December 2004. A total of 23 188 investigations were reported. No fatal event occurred. AEs were reported in 29 cases, of which only two were graded as serious; the rest, 27, were nonserious (23 mild, three moderate and one severe). The overall reporting rate of serious AE was 0.0086%. Overall, only four AEs required treatment (two serious, two nonserious including one moderate and one severe AEs). In conclusion, the present large-scale retrospective analysis showed that SonoVue has a good safety profile in abdominal applications, with an AE reporting rate lower than or similar to that reported for radiologic and magnetic resonance contrast agents.
Evaluation of penile ultrasonic velocitometry versus penile duplex ultrasonography to assess penile arterial hemodynamics. [2019]A prospective study was performed comparing duplex ultrasonography (DU) and ultrasonic velocitometry (UV), using a new fixed-angle device, in assessing penile arterial hemodynamics. Cavernous arterial peak systolic and end-diastolic flow velocities were measured.
[The value of corpus cavernosum sonography following administration of vasoactive substances in the diagnosis of patients with erectile impotence]. [2015]In 70 Patients with erectile dysfunction, ultrasound examination of both corpora cavernosa after intracavernous injection of papaverine was done using B-scan, Duplex scan and Doppler color. B-scan can detect morphological disease in a penis profundis, the higher degrees of cavernous muscle myopathia, and disease of the tunica albuginea. For the analysis of pulse curve and the measurement of blood-flow velocity, the Duplex scan is necessary. Doppler color imaging enables ultra sonographic examination of a dorsalis and a penis profundis and can detect intracavernous vascular pathology. The results show that ultrasonography is an important diagnostic tool in patients with erectile dysfunction. A differentiated therapeutic strategy can be based on this examination, especially when revascularization procedures are being discussed. Additionally, better follow-up of patients under self-injection therapy is possible.