Shock Wave vs. On-demand Tadalafil for Erectile Dysfunction

Not Applicable

• Conditions: Erectile Dysfunction
• Interventions: Device: LI-ESWT; Drug: Tadalafil 20Mg Oral Tablet

• Registration Number: NCT05199727
• Lead Sponsor: Menoufia University

Brief Summary

The objective of this study is to evaluate the effectiveness and safety of focused Li-ESWT on 25 participants complaining of ED compared to 25 participants complaining of ED on medical treatment on a prospective clinical trial for 12 weeks.

Detailed Description

Penile erection is a very complex process which requires a delicate and coordinated equilibrium among the neurological, vascular and the tissue compartments. It also includes arterial dilation, trabecular smooth muscle relaxation, and activation of the corporeal veno occlusive mechanism.Erectile dysfunction is defined as persistent inability to achieve or maintain the erection that is sufficient to permit satisfactory sexual intercours. It has a multifactorial pathogenesis, one of them is vasculogenic ED that occurs due to diseases such as diabetes mellitus, hypertension, hyperlipidemia, smoking, or vascular occlusive disease.

ED is also the most commonly treated sexual disorder and it affects approximately 20% of adult males over the age of 20. Nowadays, there are several treatment solutions for patients with ED, either non-invasive or invasive but the phosphodiesterase 5 inhibitors are still the first-line therapy for ED.

However, PDE5-Is effect is limited due to their inability to improve penile blood flow for a time period that is sufficient to allow optimal oxygenation and recovery of Cavernosal vasculature. Also, they cannot improve spontaneous erections. Moreover, several patients ranging from 40% to 50% will not respond to drug therapy even after optimization approaches such as treatment combinations have been implemented.

Also, it was proven that the effect of long-term daily use of PDE5-Is on endothelial function has induced a short-term improvement in erectile function but probably not a longstanding one.

Another option for ED patients is the use of intracavernosal injections which is considered the second line of treatment. Although PDE5-Is and intracavernosal injections are effective and safe vasodilating agents, they are unable to alter the underlying predominant pathology in patients with vasculogenic ED (eg, cavernosal artery insufficiency).

Other options include the use of intraurethral injections, or vacuum constrictive devices that could serve as salvage therapy for patients who failed to respond to PDE5-Is. If the previous options failed or not preferred by the patient, penile prosthesis implantation would be the last resort treatment for ED.

Many trials were done to find a new treatment modality that would provide a rehabilitative or curative effect for ED. This modality should affect the endothelial function and improve penile hemodynamics. One of these modalities was low-intensity extracorporeal shockwave therapy.

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2021-12-20
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-06
• Last Update Submitted: 2022-01-06
• Study First Posted: 2022-01-20
• Last Update Posted: 2022-01-20
• Primary Completion: 2022-03
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

• Male patients
• ED at least for 6 months
• vasculogenic ED
• from 25-60 years old

Exclusion Criteria

• psychological patents
• neurological patients
• younger than 25 years old
• older than 60 years old

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shockwave group	LI-ESWT	This group will receive 6 sessions (2 per week) with average 6,000 shocks per session with the PiezoWave2 unit
Medical Treatment Group	Tadalafil 20Mg Oral Tablet	This group will receive self-administered Tadalafil on-demand

Primary Outcome Measures

Name	Time	Method
Erectile function assessed by International Index of Erectile Function-5	3 months	We will asessess erectile function using International Index of Erectile Function-5 (IIEF-5) where scores ≤6, severe; 8-16, moderate; 17-21, mild; and 22-25, none.

Secondary Outcome Measures

Name	Time	Method
Erection hardness score	3 months	We will assess the Erection Hardness Score (EHS) was based on self-estimated rigidity, categorized using a scale of 1- 4: (1) the penis is larger but not hard, (2) the penis is hard but not hard enough for penetration, (3) the penis is hard enough for penetration but not completely hard, and (4) the penis is completely hard and fully rigid for coitus

Trial Locations

Locations (1)

Menoufia University; 🇪🇬 Cairo, Egypt