Erectile DysfunctionPhase 4NCT07574268
Efficacy of Transcutaneous Electrical Neural Stimulation and Tadalafil in Men With Erectile Dysfunction: A Randomized, Double-Blind, Bi-centric, Placebo- and Sham-Controlled Trial
A Phase 4 study testing Placabo, Tadalafil 5 mg and Active TENS in people with Erectile Dysfunction, run by Menoufia University at 1 site in Egypt.
Trial summary
Organic erectile failure is thought to be caused predominantly by neurogenic or vascular disorders. Venoocclusive dysfunction of the corpora cavernosa induces erectile dysfunction in 20-30% and appears clinically by premature erection loss. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Placabo, Tadalafil 5 mg and Active TENS
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 185 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2025to 1 Apr 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of erectile dysfunction for at least 6 months and confirmed with penile color doppler ultrasound
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Organic erectile failure is thought to be caused predominantly by neurogenic or vascular disorders. Venoocclusive dysfunction of the corpora cavernosa induces erectile dysfunction in 20-30% and appears clinically by premature erection loss.
The increased venous outflow from the corpora cavernosa can be illustrated as a so called 'venous leakage' by cavernosography being responsible for the therapeutical failure of intracavernously applied vasoactive substances. Cavernous smooth muscle pathology proven in some of the patients with venous leakage gave little hope to reconstructive surgery.
Read more
However, own examinations let assume that the etiology of 'venous leakage' is caused by endogenic and exogenic factors. Furthermore, reversible venous leakage was observed. Any therapeutic option of the veno-occlusive dysfunction showed disappointing results with a respective success rate of 20% in the long-term follow-up (surgical venous resection, percutaneous transpenile venous embolisms).
Finally the vacuum device or penile prosthetics are the only therapeutical option for the patients. Physiologically, bulbocavernous and ischiocavernous muscles increase the intracavernous pressure of the tumescent penis.
Regular pelvic floor exercise can be achieved by a physiotherapist which seems to be a time-consuming and expensive procedure, or an advantageous transcutaneous electrical stimulation which is the standard therapy for the treatment of posttraumatic atrophy of the striated muscular system.
Thus an external stimulator device has been developed to evaluate the therapeutical potency of striated muscle exercise in patients with erectile dysfunction. The present clinical study documents the first experiences with this EIS device and outlines its potency for the treatment of erectile dysfunction.
- Conditions
- Erectile Dysfunction
- Being tested
- Placabo, Tadalafil 5 mg, Sham stimulation, Active TENS
- Keywords
- Erectile Dysfunction, TENS, transcutaneous electrical neural stimulation, tadalafil
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlacaboDrug
Placebo resembling Tadalafil 5 mg oral tablet to be given once daily for 3 months
Tadalafil 5 mgDrug
Tadalafil 5 mg oral tablet to be given once daily for 3 months
Sham stimulationDevice
Electrical stimulation using PhalliMax system which delivers low-frequency and low-intensity TENS currents. The stimulation is intended to treat cavernous smooth muscle insufficiency by stimulating penile tissue to enhance blood flow. Self-adhesive electrodes were systematically applied on the patient according to a specific anatomical configuration: 1) Electrodes were placed on the lateral sides of the penile shaft or in a circumferential manner below the glans and at the penile root to target the corpora cavernosa. 2) Electrodes were placed on the perineum and suprapubic region to target the pelvic floor muscles. Patients were instructed to perform the stimulation sessions daily for a duration of 30 minutes for 3 months. Pulse frequency is set to 30 Hz, width to 85 microseconds a and stimulation cycles included stimulation phase for 3 seconds then rest phase for 6 seconds.
Here patients will receive only one stimulation cycle for 3 seconds then output decline to zero.
Active TENSDevice
Electrical stimulation using PhalliMax system which delivers low-frequency and low-intensity TENS currents. The stimulation is intended to treat cavernous smooth muscle insufficiency by stimulating penile tissue to enhance blood flow. Self-adhesive electrodes were systematically applied on the patient according to a specific anatomical configuration: 1) Electrodes were placed on the lateral sides of the penile shaft or in a circumferential manner below the glans and at the penile root to target the corpora cavernosa. 2) Electrodes were placed on the perineum and suprapubic region to target the pelvic floor muscles. Patients were instructed to perform the stimulation sessions daily for a duration of 30 minutes for 3 months. Pulse frequency is set to 30 Hz, width to 85 microseconds a and stimulation cycles included stimulation phase for 3 seconds then rest phase for 6 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Sham-placebo | Other | This group will receive Sham stimulation along with Placebo similar to tadalafil Receives: Drug: Placabo; Device: Sham stimulation |
| Active-Placebo | Other | This group will receive active stimulation along with Placebo similar to tadalafil Receives: Drug: Placabo; Device: Active TENS |
| Sham-Tadalafil | Other | This group will receive Sham stimulation along with tadalafil Receives: Drug: Tadalafil 5 mg; Device: Sham stimulation |
| Active-Tadalafil | Other | This group will receive active stimulation along with tadalafil Receives: Drug: Tadalafil 5 mg; Device: Active TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak systolic volume
Measured in cm/s to assess the arterial inflow via Penile Color Doppler Ultrasound
Measured: 3 months
End diastolic volume
Measured in cm/s to evaluate the integrity of the veno-occlusive mechanism via Penile Color Doppler Ultrasound
Measured: 3 months
Resistive index
equals peak systolic volume - end diastolic volume / peak systolic volume, all measured via Penile Color Doppler Ultrasound
Measured: 3 months
Secondary outcomes (2)
Erection Hardness Score
a Doppler-related erection grading system with the following Grades: Grade0: Lack of response, Grade1: Mild tumescence, Grade2: Tumescence insufficient for penetration, Grade3: Rigidity sufficient for penetration and Grade4: Complete rigidity. via Penile Color Doppler Ultrasound
Measured: 3 months
IIEF-5 score
The IIEF-5 questionnaire (International Index of Erectile Function) is a 5-item, validated tool used to diagnose the presence and severity of erectile dysfunction (ED) where Scores range from 5-25, with lower scores indicating more severe dysfunction
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start1 May 2025
- Primary completion1 Jan 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ammar Fathi Mohamed AlOrabi, Menoufia University
- Investigators
- Mohamed Alhefnawy, Study director, Urology Department, Benha University, Benha, Qalubia, EgyptIslam Said, Principal investigator, Urology Department, Benha University, Benha, Qalubia, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07574268
- Sponsor's protocol ID
- TENS and Tadalafil in ED
- Status last verified
- May 2026
- First submitted
- 3 May 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Transcutaneous Electrical Neural Stimulation and Tadalafil in Men With Erectile Dysfunction: A Randomized, Double-Blind, Bi-centric, Placebo- and Sham-Controlled Trial
- ClinicalTrials.gov ID
- NCT07574268
- Acronym / sponsor ID
- TENS and Tadalafil in ED
- Conditions
- Erectile Dysfunction
- Keywords
- Erectile Dysfunction, TENS, transcutaneous electrical neural stimulation, tadalafil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Organic erectile failure is thought to be caused predominantly by neurogenic or vascular disorders. Venoocclusive dysfunction of the corpora cavernosa induces erectile dysfunction in 20-30% and appears clinically by premature erection loss.
The increased venous outflow from the corpora cavernosa can be illustrated as a so called 'venous leakage' by cavernosography being responsible for the therapeutical failure of intracavernously applied vasoactive substances. Cavernous smooth muscle pathology proven in some of the patients with venous leakage gave little hope to reconstructive surgery.
However, own examinations let assume that the etiology of 'venous leakage' is caused by endogenic and exogenic factors. Furthermore, reversible venous leakage was observed. Any therapeutic option of the veno-occlusive dysfunction showed disappointing results with a respective success rate of 20% in the long-term follow-up (surgical venous resection, percutaneous transpenile venous embolisms).
Finally the vacuum device or penile prosthetics are the only therapeutical option for the patients. Physiologically, bulbocavernous and ischiocavernous muscles increase the intracavernous pressure of the tumescent penis.
Regular pelvic floor exercise can be achieved by a physiotherapist which seems to be a time-consuming and expensive procedure, or an advantageous transcutaneous electrical stimulation which is the standard therapy for the treatment of posttraumatic atrophy of the striated muscular system.
Thus an external stimulator device has been developed to evaluate the therapeutical potency of striated muscle exercise in patients with erectile dysfunction. The present clinical study documents the first experiences with this EIS device and outlines its potency for the treatment of erectile dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sham-placebo | Other | Drug: Placabo, Device: Sham stimulationThis group will receive Sham stimulation along with Placebo similar to tadalafil |
| Active-Placebo | Other | Drug: Placabo, Device: Active TENSThis group will receive active stimulation along with Placebo similar to tadalafil |
| Sham-Tadalafil | Other | Drug: Tadalafil 5 mg, Device: Sham stimulationThis group will receive Sham stimulation along with tadalafil |
| Active-Tadalafil | Other | Drug: Tadalafil 5 mg, Device: Active TENSThis group will receive active stimulation along with tadalafil |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- clinical diagnosis of erectile dysfunction for at least 6 months and confirmed with penile color doppler ultrasound
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlacaboPlacebo resembling Tadalafil 5 mg oral tablet to be given once daily for 3 months | Drug | Active-Placebo, Sham-placebo |
| Tadalafil 5 mgTadalafil 5 mg oral tablet to be given once daily for 3 months | Drug | Active-Tadalafil, Sham-Tadalafil |
| Sham stimulationElectrical stimulation using PhalliMax system which delivers low-frequency and low-intensity TENS currents. The stimulation is intended to treat cavernous smooth muscle insufficiency by stimulating penile tissue to enhance blood flow. Self-adhesive electrodes were systematically applied on the patient according to a specific anatomical configuration: 1) Electrodes were placed on the lateral sides of the penile shaft or in a circumferential manner below the glans and at the penile root to target the corpora cavernosa. 2) Electrodes were placed on the perineum and suprapubic region to target the pelvic floor muscles. Patients were instructed to perform the stimulation sessions daily for a duration of 30 minutes for 3 months. Pulse frequency is set to 30 Hz, width to 85 microseconds a and stimulation cycles included stimulation phase for 3 seconds then rest phase for 6 seconds. Here patients will receive only one stimulation cycle for 3 seconds then output decline to zero. | Device | Sham-Tadalafil, Sham-placebo |
| Active TENSElectrical stimulation using PhalliMax system which delivers low-frequency and low-intensity TENS currents. The stimulation is intended to treat cavernous smooth muscle insufficiency by stimulating penile tissue to enhance blood flow. Self-adhesive electrodes were systematically applied on the patient according to a specific anatomical configuration: 1) Electrodes were placed on the lateral sides of the penile shaft or in a circumferential manner below the glans and at the penile root to target the corpora cavernosa. 2) Electrodes were placed on the perineum and suprapubic region to target the pelvic floor muscles. Patients were instructed to perform the stimulation sessions daily for a duration of 30 minutes for 3 months. Pulse frequency is set to 30 Hz, width to 85 microseconds a and stimulation cycles included stimulation phase for 3 seconds then rest phase for 6 seconds. | Device | Active-Placebo, Active-Tadalafil |
Primary outcome
Peak systolic volume
Time frame: 3 months
Measured in cm/s to assess the arterial inflow via Penile Color Doppler Ultrasound
End diastolic volume
Time frame: 3 months
Measured in cm/s to evaluate the integrity of the veno-occlusive mechanism via Penile Color Doppler Ultrasound
Resistive index
Time frame: 3 months
equals peak systolic volume - end diastolic volume / peak systolic volume, all measured via Penile Color Doppler Ultrasound
2 secondary outcomes
Erection Hardness Score
Time frame: 3 months
IIEF-5 score
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Alhefnawy study director
Urology Department, Benha University, Benha, Qalubia, Egypt
Islam Said principal investigator
Urology Department, Benha University, Benha, Qalubia, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Placabo, Tadalafil 5 mg and Active TENS in people with Erectile Dysfunction, run by Menoufia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak systolic volume (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.