Shock Wave vs. On-demand Tadalafil for Erectile Dysfunction

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of the Efficacy and Safety of Low Intensity Extracorporeal Shock Wave Therapy Versus On-demand Tadalafil for Erectile Dysfunction

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Device: LI-ESWT
* Drug: Tadalafil 20Mg Oral Tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shockwave group<br>This group will receive 6 sessions (2 per week) with average 6,000 shocks per session with the PiezoWave2 unit | Device: LI-ESWT<br>* Low intenisty shockwave therapy newly used for treatment of erectile dysfunction by applying 6 sessions on 3 weeks (2 sessions /week)<br>* Other names: Shockwave therapy;|
| Active Comparator: Medical Treatment Group<br>This group will receive self-administered Tadalafil on-demand | Drug: Tadalafil 20Mg Oral Tablet<br>* Patients on this arm will allocate on on-demand tadalafil 20 mg for treatment of ED<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erectile function assessed by International Index of Erectile Function-5 | 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erection hardness score | 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 | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erectile dysfunction, Shock wave, Clinical trial