VERTICA Device for Erectile Dysfunction

Recruiting at 3 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

Trial Summary

What is the purpose of this trial?

This trial involves using a device called VERTICA® to help adults with mild to moderate erectile dysfunction (ED). Participants will use the device at home for several months and report their experiences. The goal is to see if the device can improve their ability to achieve and maintain an erection.

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 data supports the effectiveness of the VERTICA RF Device treatment for erectile dysfunction?

The vacuum erection device (VED), which is similar to the VERTICA RF Device, has been shown to be effective in treating erectile dysfunction, especially in patients who do not respond well to oral medications. Studies have demonstrated that VEDs can help achieve successful erections and are beneficial in penile rehabilitation after prostate surgery. ^{1 2 3 4 5}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. England 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. [2015]

2. United States 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. [2021]

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

Vacuum erection devices to treat erectile dysfunction and early penile rehabilitation following radical prostatectomy. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Efficacy of vacuum erectile devices (VEDs) after radical prostatectomy: the initial Irish experience of a dedicated VED clinic. [2018]

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

Efficacy of the vacuum constriction device in patients with corporeal venous occlusive dysfunction. [2010]