Comparison of different shock wave therapies in the treatment of erectile dysfunction
| ISRCTN | ISRCTN14000407 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14000407 |
| Secondary identifying numbers | 20131113 |
- Submission date
- 10/10/2025
- Registration date
- 10/10/2025
- Last edited
- 10/10/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Erectile dysfunction (ED) is the inability to get or keep an erection firm enough for sexual activity. It is a common condition, affecting up to half of men aged between 40 and 70 years. One of the newer treatments for ED uses shock waves called shockwave therapy to improve blood flow in the penis. There are two main types of this treatment: focused shockwave therapy (fSWT) and radial wave therapy (rWT). Both are believed to stimulate the growth of new blood vessels and improve tissue health. The aim of this study is to compare the long-term effectiveness of these two methods in improving erectile function in men with blood vessel related ED.
Who can participate?
Men aged 40 to 70 years who have had erectile dysfunction for at least 3 months and have a moderate to severe reduction in erectile function
What does the study involve?
This was a two-centre prospective cohort study, meaning men were treated and followed over time in two different hospitals. One group received focused shockwave therapy (fSWT) using a device called ED1000, and the other group received radial wave therapy (rWT) using a Zimmer enPuls Pro device. Both treatments involved a series of short, painless sessions over several weeks. No anaesthesia or medication was required. Participants completed questionnaires on erectile function before treatment, after 3 months, and again after 1 year.
What are the possible benefits and risks of participating?
The possible benefit is improved erectile function and better sexual performance without the need for medication or surgery.
The treatment is considered safe and non-invasive, with no reported serious side effects. Some men might experience mild temporary discomfort during treatment, but no long-term risks are expected.
Where is the study run from?
1. Göksel Bayar Special Healthcare Company (Turkiye)
2. Ismail Basmaci Special Healthcare Company (Turkiye)
When is the study starting and how long is it expected to run for?
June 2021 to July 2024
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Assoc. Prof. Göksel Bayar, goxelle@gmail.com, goksel.bayar@medicalpark.com.tr
Contact information
Public, Scientific, Principal investigator
Guzelller Mah Kavak Cad Medical Park Hastanesi
Gebze
41400
Türkiye
| Phone | +90 (0)5315849749 |
|---|---|
| goksel.bayar@medicalpark.com.tr |
Study information
| Study design | Non-randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Comparative effectiveness of focused shockwave therapy and radial wave therapy for erectile dysfunction: a two-centre prospective cohort study |
| Study objectives | To evaluate the efficacy of focused and non-focused shock wave treatment of erectile dysfunction for at least 1 year. |
| Ethics approval(s) |
Approved 01/06/2023, Samsun University Local Ethics Committee (İstiklal Mahallesi Tekel Cad, Ballıca Kampüsü No:2, 19 Mayıs, Samsun, 55000, Türkiye; +90 (0)3623130055; samsununu.kaek@gmail.com), ref: 20231224 |
| Health condition(s) or problem(s) studied | Erectile dysfunction |
| Intervention | This was a two-centre prospective cohort study, meaning men were treated and followed over time in two different hospitals. One group received focused shockwave therapy (fSWT) using a device called ED1000, and the other group received radial wave therapy (rWT) using a Zimmer enPuls Pro device. Both treatments involved a series of short, painless sessions over several weeks. No anaesthesia or medication was required. Participants completed questionnaires on erectile function before treatment, after 3 months, and again after 1 year. Chi-square and Student's t-tests will be used for statistical comparison. The Wilson test will be used to assess the effectiveness of the treatments themselves. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Shock wave treatment |
| Primary outcome measure | Erectile function measured using the International Index of Erectile Function (IIEF) score before treatment, after 3 months, and after 1 year |
| Secondary outcome measures | Sexual function assessed using the Sexual Encounter Profile (SEP) before treatment, after 3 months, and after 1 year |
| Overall study start date | 01/06/2021 |
| Completion date | 01/07/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 30 Years |
| Upper age limit | 70 Years |
| Sex | Male |
| Target number of participants | 200 |
| Total final enrolment | 200 |
| Key inclusion criteria | Erectile dysfunction patients with vascular insuffiency |
| Key exclusion criteria | 1. Pelvic surgery, e.g. radical prostatectomy 2. Radiotherapy 3. Neuropathic illness |
| Date of first enrolment | 01/07/2023 |
| Date of final enrolment | 01/07/2024 |
Locations
Countries of recruitment
- Türkiye
Study participating centres
Gebze
41400
Türkiye
Mardin
47060
Türkiye
Sponsor information
Industry
Guzelller Mah Kavak Cad Medical Park Hastanesi
Gebze
41400
Türkiye
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in andrology journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
10/10/2025: Study's existence confirmed by the Samsun University Local Ethics Committee.
