Shock Wave vs. On-demand Tadalafil for Erectile Dysfunction
NCT ID: NCT05199727
Last Updated: 2022-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2021-09-01
2022-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Shockwave group
This group will receive 6 sessions (2 per week) with average 6,000 shocks per session with the PiezoWave2 unit
LI-ESWT
Low intenisty shockwave therapy newly used for treatment of erectile dysfunction by applying 6 sessions on 3 weeks (2 sessions /week)
Medical Treatment Group
This group will receive self-administered Tadalafil on-demand
Tadalafil 20Mg Oral Tablet
Patients on this arm will allocate on on-demand tadalafil 20 mg for treatment of ED
Interventions
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LI-ESWT
Low intenisty shockwave therapy newly used for treatment of erectile dysfunction by applying 6 sessions on 3 weeks (2 sessions /week)
Tadalafil 20Mg Oral Tablet
Patients on this arm will allocate on on-demand tadalafil 20 mg for treatment of ED
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ED at least for 6 months
* vasculogenic ED
* from 25-60 years old
Exclusion Criteria
* neurological patients
* younger than 25 years old
* older than 60 years old
25 Years
60 Years
MALE
Yes
Sponsors
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Menoufia University
OTHER
Responsible Party
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Hosam Kotb
Principal investigator
Principal Investigators
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fouad zanaty, professor
Role: STUDY_DIRECTOR
Menoufia University
Locations
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Menoufia University
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Other Identifiers
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5/2021UROL9
Identifier Type: -
Identifier Source: org_study_id
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