Shock Wave vs. On-demand Tadalafil for Erectile Dysfunction

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05199727
• Other study ID #: 5/2021UROL9
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: May 2022

Study information

• Verified date: January 2022
• Source: Menoufia University
• Contact: HOSAM KOTB, master
• Phone: 01022707580
• Email: hosam.kotb2020[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Device:
• LI-ESWT
Low intenisty shockwave therapy newly used for treatment of erectile dysfunction by applying 6 sessions on 3 weeks (2 sessions /week)

Drug:
• Tadalafil 20Mg Oral Tablet
Patients on this arm will allocate on on-demand tadalafil 20 mg for treatment of ED

Locations

Country	Name	City	State
Egypt	Menoufia University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Clavijo RI, Kohn TP, Kohn JR, Ramasamy R. Effects of Low-Intensity Extracorporeal Shockwave Therapy on Erectile Dysfunction: A Systematic Review and Meta-Analysis. J Sex Med. 2017 Jan;14(1):27-35. doi: 10.1016/j.jsxm.2016.11.001. Epub 2016 Dec 13. Review. — View Citation

Dong L, Chang D, Zhang X, Li J, Yang F, Tan K, Yang Y, Yong S, Yu X. Effect of Low-Intensity Extracorporeal Shock Wave on the Treatment of Erectile Dysfunction: A Systematic Review and Meta-Analysis. Am J Mens Health. 2019 Mar-Apr;13(2):1557988319846749. doi: 10.1177/1557988319846749. — View Citation

Mo DS, Zhan XX, Shi HW, Cai HC, Meng J, Zhao J, Shang XJ. [Efficacy and safety of low-intensity extracorporeal shock wave therapy in the treatment of ED: A meta-analysis of randomized controlled trials]. Zhonghua Nan Ke Xue. 2019 Mar;25(3):257-264. Chinese. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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