Efficacy of Transcutaneous Electrical Neural Stimulation and Tadalafil in Men With Erectile Dysfunction: A Randomized, Double-Blind, Bi-centric, Placebo- and Sham-Controlled Trial

NCT07574268 | Completed Phase 4

• 1 other identifier: TENS and Tadalafil in ED
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Erectile Dysfunction

Keywords

Erectile Dysfunction; TENS; transcutaneous electrical neural stimulation; tadalafil

Outcome Measures

Primary Outcomes (3)

• Peak systolic volume

  Measured in cm/s to assess the arterial inflow via Penile Color Doppler Ultrasound

  3 months

• End diastolic volume

  Measured in cm/s to evaluate the integrity of the veno-occlusive mechanism via Penile Color Doppler Ultrasound

  3 months

• Resistive index

  equals peak systolic volume - end diastolic volume / peak systolic volume, all measured via Penile Color Doppler Ultrasound

  3 months

Secondary Outcomes (2)

• Erection Hardness Score

  3 months

• IIEF-5 score

  3 months

Study Arms (4)

Sham-placebo

OTHER

This group will receive Sham stimulation along with Placebo similar to tadalafil

Drug: Placabo; Device: Sham stimulation

Active-Placebo

OTHER

This group will receive active stimulation along with Placebo similar to tadalafil

Drug: Placabo; Device: Active TENS

Sham-Tadalafil

OTHER

This group will receive Sham stimulation along with tadalafil

Drug: Tadalafil 5 mg; Device: Sham stimulation

Active-Tadalafil

OTHER

This group will receive active stimulation along with tadalafil

Drug: Tadalafil 5 mg; Device: Active TENS

Interventions

Placabo DRUG

Placebo resembling Tadalafil 5 mg oral tablet to be given once daily for 3 months

Active-Placebo; Sham-placebo

Tadalafil 5 mg DRUG

Tadalafil 5 mg oral tablet to be given once daily for 3 months

Active-Tadalafil; Sham-Tadalafil

Sham stimulation DEVICE

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.

Sham-Tadalafil; Sham-placebo

Active TENS DEVICE

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.

Active-Placebo; Active-Tadalafil

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical diagnosis of erectile dysfunction for at least 6 months and confirmed with penile color doppler ultrasound

You may not qualify if:

• 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

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menoufia Faculty of Medicine

Shebin El-Kom, Menoufia, 32511, Egypt

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Mohamed Alhefnawy

  Urology Department, Benha University, Benha, Qalubia, Egypt

  STUDY DIRECTOR

• Islam Said

  Urology Department, Benha University, Benha, Qalubia, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: May 3, 2026
• First Posted: May 7, 2026
• Study Start: June 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: March 1, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-05

Locations

EG (1)