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Shock therapy for ED? new trial tests TENS device and tadalafil

NCT ID NCT07574268

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 03, 2026 · Updated 3 times

Summary

This study tested two treatments for erectile dysfunction (ED) in 185 men: a daily tadalafil pill (5 mg) and a nerve stimulation device (TENS) that sends mild electrical pulses to the penis. The goal was to see if these treatments improve blood flow and erection hardness. The trial compared the real treatments to placebo pills and sham stimulation. Results could point to new ways to manage ED without surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tadalafil and transcutaneous electrical neural stimulation (TENS) device
What this could lead to
If successful, this could offer men with erectile dysfunction a non-surgical, drug-free option using electrical stimulation, possibly combined with a daily pill.
What could go wrong
This is a completed Phase 4 trial, but results may not apply to all men with ED, especially those with heart conditions or pacemakers. The electrical device may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

185 people

The number who actually took part.

Started

May 2025

Finished

Apr 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * clinical diagnosis of erectile dysfunction for at least 6 months and confirmed with penile color doppler ultrasound Exclusion Criteria: * Patients with history of cardiovascular disease, contraindication for phosphodiesterase type 5 inhibitor, implanted cardiac pacemakers or defibrillators, anatomically significant penile deformities, active skin lesions at the electrode placement sites or any untreated endocrinal disorder that could affect the erectile function

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Menoufia Faculty of Medicine

    Shebin El-Kom, Menoufia, 32511, Egypt

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Other studies related to the condition(s) this trial covers.