Erectile DysfunctionNCT05199727
Shock Wave vs. On-demand Tadalafil for Erectile Dysfunction
A study testing LI-ESWT and Tadalafil 20Mg Oral Tablet in people with Erectile Dysfunction, run by Menoufia University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 25 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- LI-ESWT and Tadalafil 20Mg Oral Tablet
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2021to May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male patients
- ED at least for 6 months
- vasculogenic ED
- from 25-60 years old
Who cannot join
- psychological patents
- neurological patients
- younger than 25 years old
- older than 60 years old
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Menoufia University
Cairo, 32632
Menoufia University, 048 2222170, irbmnf@mnf.edu.eg
About this study
Official title: Comparison of the Efficacy and Safety of Low Intensity Extracorporeal Shock Wave Therapy Versus On-demand Tadalafil for Erectile Dysfunction
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.
Read the 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.
- Conditions
- Erectile Dysfunction
- Being tested
- LI-ESWT, Tadalafil 20Mg Oral Tablet
- Keywords
- Erectile dysfunction, Shock wave, Clinical trial
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LI-ESWTDevice
Also called Shockwave therapy
Low intenisty shockwave therapy newly used for treatment of erectile dysfunction by applying 6 sessions on 3 weeks (2 sessions /week)
Tadalafil 20Mg Oral TabletDrug
Patients on this arm will allocate on on-demand tadalafil 20 mg for treatment of ED
| Study group | Role | What they receive |
|---|---|---|
| Shockwave group | Experimental | This group will receive 6 sessions (2 per week) with average 6,000 shocks per session with the PiezoWave2 unit Receives: Device: LI-ESWT |
| Medical Treatment Group | Active comparator | This group will receive self-administered Tadalafil on-demand Receives: Drug: Tadalafil 20Mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start1 Sep 2021
- Primary completionMar 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hosam Kotb, Menoufia University
- Investigators
- fouad zanaty, professor, Study director, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05199727
- Sponsor's protocol ID
- 5/2021UROL9
- Status last verified
- Jan 2022
- First submitted
- 20 Dec 2021
- Last updated
- 20 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31027441Clavijo 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.
PubMed 27986492Mo 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.
PubMed 32216245
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy and Safety of Low Intensity Extracorporeal Shock Wave Therapy Versus On-demand Tadalafil for Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT05199727
- Acronym / sponsor ID
- 5/2021UROL9
- Conditions
- Erectile Dysfunction
- Keywords
- Erectile dysfunction, Shock wave, Clinical trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shockwave group | Experimental | Device: LI-ESWTThis group will receive 6 sessions (2 per week) with average 6,000 shocks per session with the PiezoWave2 unit |
| Medical Treatment Group | Active comparator | Drug: Tadalafil 20Mg Oral TabletThis group will receive self-administered Tadalafil on-demand |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male patients
- ED at least for 6 months
- vasculogenic ED
- from 25-60 years old
Key exclusion criteria (4 listed)
- psychological patents
- neurological patients
- younger than 25 years old
- older than 60 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LI-ESWTAlso: Shockwave therapyLow intenisty shockwave therapy newly used for treatment of erectile dysfunction by applying 6 sessions on 3 weeks (2 sessions /week) | Device | Shockwave group |
| Tadalafil 20Mg Oral TabletPatients on this arm will allocate on on-demand tadalafil 20 mg for treatment of ED | Drug | Medical Treatment Group |
Primary outcome
Erectile function assessed by International Index of Erectile Function-5
Time frame: 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.
1 secondary outcome
Erection hardness score
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
- Background: PubMed 31027441Dong 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.
- Background: PubMed 27986492Clavijo 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.
- Background: PubMed 32216245Mo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
fouad zanaty, professor study director
Menoufia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LI-ESWT and Tadalafil 20Mg Oral Tablet in people with Erectile Dysfunction, run by Menoufia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact HOSAM KOTB, master (01022707580, hosam.kotb2020@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erectile function assessed by International Index of Erectile Function-5 (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05199727, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2022.