Erectile DysfunctionNCT04059341
Early Extracorporeal Shockwave Therapy for Erectile Dysfunction in Radically Prostatectomised Men.
A study testing Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) in people with Erectile Dysfunction and Extracorporeal Shockwave Therapy, run by Odense University Hospital at 1 site in Denmark.
Trial summary
The purpose of this project is to assess the relationship between low intensity shock wave treatment (LI-SWT) and erectile function (ED) in patients who have undergone radical prostatectomy (RP). Read more about this study
- Who is it for?
- Ages 20 to 80 years, men only
- Conditions the study is for
- Erectile Dysfunction, Extracorporeal Shockwave Therapy, Radical Prostatectomy
- What is being tested?
- Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2019to 1 Jul 2020
- 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 20 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Radically prostatectomised men
- Non nerve-sparing or nerve-sparing RP.
- Age 20-80 years
- Have been in a relationship for more than 3 months.
- Sexually active
- Patient can give informed consent.
Who cannot join
- Men with ED of neuropathological or psychogenic origin
- Rectal extirpation, radiation therapy to the pelvic area and recovery from any other cancer within the past 5 years are excluded.
- Patients with heart disease prohibiting sexual activity or taking medication with antiandrogens, anticoagulant (apart from aspirin) or systemic use of glucocorticoids within 5 weeks.
Trial locations and contacts
1 site in 1 country.
Lars Lund, Professor contact
Denmark1 site
Odense University Hospital
Odense, 5000
Ali Moumneh, BSc.med, almou15@student.sdu.dk
About this study
The purpose of this project is to assess the relationship between low intensity shock wave treatment (LI-SWT) and erectile function (ED) in patients who have undergone radical prostatectomy (RP).
- Being tested
- Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT)
- Keywords
- Radical Prostatectomy, Prostatectomy, Nerve-sparing, Non nerve-sparing, Erectile dysfunction, Erectile function, Shockwave, LI-ESWT, ESWT, Low intensity extracorporeal shockwave therapy, extracorporeal shockwave therapy
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT)Device
Five sessions of penile Low Intensity Extracorporeal Shockwave Therapy initiated three weeks after radical prostatectomy.
| Study group | Role | What they receive |
|---|---|---|
| Active LI-ESWT | Experimental | Active group receives five sessions of low intensity extracorporeal shockwave treatment, once per week for five consecutive weeks. Treatment is initiated three weeks after radical prostatectomy and is given using DUOLITH® SD1 manufactured by STORZ MEDICAL AG. Receives: Device: Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) |
| Sham | Sham comparator | Sham group receives five sessions of sham low intensity extracorporeal shockwave treatment, once per week for five consecutive weeks. Treatment is initiated three weeks after radical prostatectomy and is given using DUOLITH® SD1 manufactured by STORZ MEDICAL AG with a shockwave absorbing adapter. Receives: Device: Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
IIEF-5 Score 1
Change in International Index of Erectile Function (IIEF-5) score compared to baseline
Measured: One month after final treatment session
IIEF-5 Score 3
Change in International Index of Erectile Function (IIEF-5) score compared to baseline
Measured: Three months after final treatment session
IIEF-5 Score 6
Change in International Index of Erectile Function (IIEF-5) score compared to baseline
Measured: Six months after final treatment session
Secondary outcomes (5)
EDITS
Erectile Dysfunction Inventory of Treatment Satisfaction score
Measured: One month after final treatment session
RigiScan
Change in nocturnal erections compared to baseline
Measured: One month after final treatment session
EHS 1
Change in Erection Hardness Score compared to baseline
Measured: One month after final treatment session
EHS 3
Change in Erection Hardness Score compared to baseline
Measured: Three months after final treatment session
EHS 6
Change in Erection Hardness Score compared to baseline
Measured: Six months after final treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start1 Sep 2019 (estimated)
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, single-blinded, placebo-controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lars Lund,MD, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04059341
- Sponsor's protocol ID
- ELIESWTEDRP
- Status last verified
- Aug 2019
- First submitted
- 15 Aug 2019
- Last updated
- 16 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pedersen TB, Secher C, Moumneh A, Hvid N, Lund M, Fojecki G, Lund L. A Prospective Randomized Study on Low-Energy Extracorporeal Shock Wave Therapy for Erectile Dysfunction After Radical Prostatectomy. J Urol. 2025 Aug;214(2):156-166. doi: 10.1097/JU.0000000000004576. Epub 2025 Apr 27.
PubMed 40287933
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Extracorporeal Shockwave Therapy for Erectile Dysfunction in Radically Prostatectomised Men.
- ClinicalTrials.gov ID
- NCT04059341
- Acronym / sponsor ID
- ELIESWTEDRP
- Keywords
- Radical Prostatectomy, Prostatectomy, Nerve-sparing, Non nerve-sparing, Erectile dysfunction, Erectile function, Shockwave, LI-ESWT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 16 Aug 2019 (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 purpose of this project is to assess the relationship between low intensity shock wave treatment (LI-SWT) and erectile function (ED) in patients who have undergone radical prostatectomy (RP).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomised, single-blinded, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Active LI-ESWT | Experimental | Device: Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT)Active group receives five sessions of low intensity extracorporeal shockwave treatment, once per week for five consecutive weeks. Treatment is initiated three weeks after radical prostatectomy and is given using DUOLITH® SD1 manufactured by STORZ MEDICAL AG. |
| Sham | Sham comparator | Device: Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT)Sham group receives five sessions of sham low intensity extracorporeal shockwave treatment, once per week for five consecutive weeks. Treatment is initiated three weeks after radical prostatectomy and is given using DUOLITH® SD1 manufactured by STORZ MEDICAL AG with a shockwave absorbing adapter. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Radically prostatectomised men
- Non nerve-sparing or nerve-sparing RP.
- Age 20-80 years
- Have been in a relationship for more than 3 months.
- Sexually active
Key exclusion criteria (3 listed)
- Men with ED of neuropathological or psychogenic origin
- Rectal extirpation, radiation therapy to the pelvic area and recovery from any other cancer within the past 5 years are excluded.
- Patients with heart disease prohibiting sexual activity or taking medication with antiandrogens, anticoagulant (apart from aspirin) or systemic use of glucocorticoids within 5 weeks.
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 |
|---|---|---|
| Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT)Five sessions of penile Low Intensity Extracorporeal Shockwave Therapy initiated three weeks after radical prostatectomy. | Device | Active LI-ESWT, Sham |
Primary outcome
IIEF-5 Score 1
Time frame: One month after final treatment session
Change in International Index of Erectile Function (IIEF-5) score compared to baseline
IIEF-5 Score 3
Time frame: Three months after final treatment session
Change in International Index of Erectile Function (IIEF-5) score compared to baseline
IIEF-5 Score 6
Time frame: Six months after final treatment session
Change in International Index of Erectile Function (IIEF-5) score compared to baseline
5 secondary outcomes
EDITS
Time frame: One month after final treatment session
RigiScan
Time frame: One month after final treatment session
EHS 1
Time frame: One month after final treatment session
EHS 3
Time frame: Three months after final treatment session
EHS 6
Time frame: Six months after final treatment session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2019.
- Derived from this study: PubMed 40287933Pedersen TB, Secher C, Moumneh A, Hvid N, Lund M, Fojecki G, Lund L. A Prospective Randomized Study on Low-Energy Extracorporeal Shock Wave Therapy for Erectile Dysfunction After Radical Prostatectomy. J Urol. 2025 Aug;214(2):156-166. doi: 10.1097/JU.0000000000004576. Epub 2025 Apr 27.
- Individual participant dataSharing planned: No
Related trials for Erectile Dysfunction
RecruitingPhase 4
Assessment of the Value of FAPI and FDG-PET-CT in Diagnosis of Acute Phase Peyronie's Disease
Peyronie's Disease
RecruitingPhase 3
A Study to Evaluate Efficacy and Safety of HIP2602 in Erectile Dysfunction Patients
Erectile Dysfunction
RecruitingPhase 2
Multimodal Prehabilitation and Rehabilitation for Men Undergoing Robot-Assisted Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Prostate Cancer
Active, not recruiting
Efficacy of Low-dose Percutaneous Electrical Stimulation in Patients With Erectile Dysfunction.
Pudendal Nerve Injury, Erectile Dysfunction
Active, not recruiting
Treatment With Peripheral Nerve Stimulation of the Pudendal Nerve in Patients With Erectile Dysfunction
Erectile Dysfunction, Electric Stimulation
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.
Lars Lund, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) in people with Erectile Dysfunction and Extracorporeal Shockwave Therapy, run by Odense University Hospital at 1 site in Denmark.
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 6 inclusion and 3 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 16 Aug 2019. 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 Denmark. 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. Some participants in this study may receive a placebo. 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 Ali Moumneh, BSC.med (+45234826423, almou15@student.sdu.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IIEF-5 Score 1 (time frame: One month after final treatment session). The study lists 3 primary outcomes in all. 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 NCT04059341, which also lists 1 linked publication.
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 16 Aug 2019.