VERTICA Device for Erectile Dysfunction

Recruiting at 4 trial locations

Overseen By Petar Bajic, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: OHH-MED Medical Ltd

Must not be taking: Antiandrogens, Anticoagulants

Disqualifiers: Hypogonadism, Penile deformations, Neurological conditions, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

98 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new device called the VERTICA® RF Device to determine its effectiveness for men with mild to moderate erectile dysfunction (ED). Participants will use either the active device or a sham (inactive) version to compare results. The trial requires using the device at home for six months and tracking experiences after each sexual activity attempt. Men who have experienced ED for at least three months, are in a steady relationship, and are sexually active (at least weekly) may be suitable candidates. Participants must be willing to follow the study rules and have a smartphone. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new solutions for ED.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on anticoagulation or anti-platelet therapy, you cannot participate in the trial.

What prior data suggests that the VERTICA Device is safe for treating erectile dysfunction?

Research has shown that the VERTICA® RF Device may help treat mild to moderate erectile dysfunction (ED). In earlier studies, patients generally tolerated the device well. No serious side effects were reported, suggesting it is safe to use. However, like any treatment, some minor side effects might occur, but they haven't been significant enough to cause concern. The device is easy to use, which may help prevent mistakes and potential problems. Overall, current evidence suggests it is a safe option for those dealing with ED. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The VERTICA® RF Device is unique because it uses radiofrequency energy to address erectile dysfunction, a departure from the standard oral medications like Viagra and Cialis, which primarily enhance blood flow through the inhibition of specific enzymes. Unlike these oral treatments, the VERTICA® RF Device offers a non-invasive, device-based approach that may provide an alternative for those who cannot tolerate or do not respond well to pills. Researchers are excited about the potential of this device to offer a new mechanism of action that directly stimulates the physiological processes involved in achieving an erection, possibly leading to improved outcomes for patients who haven't found success with existing options.

What evidence suggests that the VERTICA device is effective for erectile dysfunction?

Research has shown that the VERTICA® RF Device might help treat mild to moderate erectile dysfunction (ED). In one study, 89% of patients improved their ability to achieve and maintain an erection, with better scores on assessments. The device addresses venous leakage, a common cause of ED, by helping control blood flow during an erection. Another study found that participants had better erectile function scores after using the device for one month. In this trial, participants will be assigned to either the active VERTICA® RF Device treatment arm or a sham comparator arm. These results suggest that the VERTICA® device could be a promising option for those dealing with ED. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for heterosexual male adults aged 22-85 with mild to moderate erectile dysfunction (ED) for at least 3 months. Participants must have a steady relationship, be sexually active, and own a smartphone. They can't join if they've had certain pelvic treatments or conditions, take specific medications, have major neurological issues, psychiatric disorders including premature ejaculation and substance abuse problems, or if their partner is pregnant.

Inclusion Criteria

I have been diagnosed with erectile dysfunction for at least 3 months.

I am sexually active, engaging in intercourse at least 6 times a month.

I am a heterosexual male aged between 22 and 85.

Exclusion Criteria

I have had bladder or colorectal cancer in the past.

History of psychiatric disorders, premature ejaculation and drug or alcohol abuse

Subjects who are cognitively challenged

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Active or Sham VERTICA® treatment, with initial treatment in a clinical setting followed by home use for 6 months

6 months

Initial in-person visit, monthly follow-up visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• VERTICA® RF Device

Trial Overview The VERTICA® RF Device's safety and effectiveness in treating ED are being tested. Men will randomly receive either the real device or a sham (fake) version to use at home for six months. They'll try sexual activity regularly and log each event while attending monthly check-ups where safety checks and more efficacy tests happen.

How Is the Trial Designed?

Group I: Active Experimental Treatment 1 Intervention

Group II: Sham Placebo Group 1 Intervention

VERTICA® RF Device is already approved in European Union for the following indications:

Approved in European Union as VERTICA RF Device for:

• Erectile dysfunction

Who Is Running the Clinical Trial?

OHH-MED Medical Ltd

Lead Sponsor

Trials

2

Recruited

130+

Published Research Related to This Trial

Several medications for treating male erectile dysfunction are being explored for women, indicating a growing interest in addressing female sexual dysfunction.

The EROS-CTD clitoral therapy device is one of the pharmacological options currently under investigation, highlighting advancements in both treatment and evaluation methods for female sexual health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of the Female Intervention Efficacy Index (FIEI) as an immediate outcome measure of medical intervention to treat female sexual dysfunction. Berman, LA., Berman, JR., Werbin, T., et al.[2015]

Vacuum erection devices (VED) are becoming a first-line treatment for erectile dysfunction, especially for patients who do not respond well to oral medications, such as older adults or those with diabetes and heart conditions.

Early use of VED after prostate cancer treatments, like radical prostatectomy, has shown promising results in preserving penile length and girth, suggesting it may play a crucial role in rehabilitation and prevention of erectile dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vacuum erection devices to treat erectile dysfunction and early penile rehabilitation following radical prostatectomy. Zippe, CD., Pahlajani, G.[2019]

Extracorporeal shock wave therapy (ESWT) and vacuum erectile devices (VED) both showed significant improvements in erectile function, with treatment success rates of 73.3% for ESWT and 67.7% for VED after 4 weeks of therapy.

Both treatments resulted in similar increases in erectile function scores (IIEF-5) and other measures, indicating that ESWT is as effective as VED for managing erectile dysfunction in the studied population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the effects of extracorporeal shock wave therapy and a vacuum erectile device on penile erectile dysfunction: a randomized clinical trial. Qi, T., Ye, L., Wang, B., et al.[2021]

In a study of 65 men attending a dedicated vacuum erectile device (VED) clinic after radical prostatectomy, 76.3% purchased a VED, indicating strong interest in this rehabilitation method.

While erectile function significantly improved with VED use compared to the 3-month postoperative scores, it remained lower than preoperative levels, highlighting the need for standardized penile rehabilitation programs to enhance recovery after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of vacuum erectile devices (VEDs) after radical prostatectomy: the initial Irish experience of a dedicated VED clinic. Nason, GJ., McNamara, F., Twyford, M., et al.[2018]

The vacuum constriction device (VED) is an effective nonsurgical treatment for erectile dysfunction in patients with corporeal veno-occlusive dysfunction (CVOD), with 76% of patients achieving satisfactory erections.

Among the 50 patients with documented CVOD, 56% reported satisfaction with the VED, indicating its efficacy is comparable to other treatments like injection therapy, regardless of the severity of their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the vacuum constriction device in patients with corporeal venous occlusive dysfunction. Kolettis, PN., Lakin, MM., Montague, DK., et al.[2010]

Citations

1. academic.oup.com academic.oup.com/jsm/article/22/Supplement_2/qdaf077.106/8127507

SAFETY AND EFFICACY ASSESSMENT OF THE VERTICA® VERTICA® device shows promise in the treatment of mild to moderate ED based on the pilot study and the ongoing trial. If the results of this ...

2. vertica-labs.com vertica-labs.com/erectile-dysfunction/

Clinical Info about RF home–use device - Vertica® Our results showed that 25/28 patients (89%) achieved an improvement in their erectile function, expressed by an increase of minimum 5 points for the moderate ...

3. clinicaltrial.be clinicaltrial.be/en/details/308110?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Safety and Efficacy of the VERTICA® RF Device for the Tre... The IIEF-EF total score ranges between 6 to 30. A higher total score indicates relatively better erectile functioning.

4. ucihealth.org ucihealth.org/about-us/news/2023/12/erectile-dysfunction-clinical-trial

UCI Health enrolls patient in first U.S. study of medical ... The Vertica device is designed to treat the root cause of ED by correcting venous leakage in the penis, ensuring that blood flow is regulated during erection.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S174360952201726X

A novel therapy for erectile dysfunction using a home ... A statistically and clinically significant improvement was demonstrated in the Full IIEF, IIEF-EF, and EHS scores at baseline vs. one month after ending ...

6. trialx.com trialx.com/clinical-trials/listings/218513/safety-and-efficacy-of-the-vertica-rf-device-for-the-treatment-of-ed/?&geo_lat=26.007&geo_lng=-80.1219&radius=10&place=Hollywood&user_country=United%20States

Safety and Efficacy of the VERTICA® RF Device for ... Clinical trial for Erectile Dysfunction , Safety and Efficacy of the VERTICA® RF Device for the Treatment of ED.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04484090

NCT04484090 | Safety and Efficacy of Ohhmed Treatments ... This study assess the safety, efficacy, ease of use, and satisfaction of the Vertica device by men with mild to moderate erectile dysfunction.

8. academic.oup.com academic.oup.com/jsm/article/21/Supplement_7/qdae167.280/7918884

A RADIO FREQUENCY DEVICE FOR THE TREATMENT OF ... In conclusion, the VERTICA® investigational device shows promise in the treatment of mild to moderate erectile dysfunction (ED) based on the pilot study and the ...