Erectile DysfunctionNCT06469775
LiSWT for Men With Erectile Dysfunction
A study testing Low intensity shock wave in people with Erectile Dysfunction, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
The goal of this a clinical trial to investigate the effect of low-intensity shock wave therapy on patients with erectile function. The main questions it aims to answer are: 1. Can low-intensity shock wave therapy (LiSWT) to the penis improve male sexual health, particularly erectile function? 2. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Low intensity shock wave
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2025to 1 Sep 2031
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male sex presenting with mild to severe erectile dysfunction for at least six months, as defined by SHIM score 1-21 and/or an EHS 0-3
- Age >18
- Ability to make independent decisions (sign own consent)
Who cannot join
- Men reliant on penile injections for erections
- Men with current penile implant
- Prisoners
- Current anticoagulant / anti-platelet therapy
- Adults who cannot make their own medical decisions
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
About this study
Official title: Low Intensity Shock Wave Therapy for Men With Mild to Moderate Erectile Dysfunction
The goal of this a clinical trial to investigate the effect of low-intensity shock wave therapy on patients with erectile function. The main questions it aims to answer are:
- Can low-intensity shock wave therapy (LiSWT) to the penis improve male sexual health, particularly erectile function?
- What is the optimal LiSWT protocol (number of shocks, energy delivered, timeline, etc) for initial and maintenance therapy?
Read more
Researchers will compare validated questionnaires on erectile function in men treated with LiSWT compared to men who receive standard of care to see if there is an improvement in erectile function with LiSWT.
Participants will be asked to complete questionnaires at each visit. Those who choose to undergo LiSWT will receive 6 sessions, once per week.
Read the detailed description
Patients meeting inclusion criteria will be prospectively recruited from a single urological practice (Rutgers Urology, 125 Paterson St. Suite 4100, New Brunswick, NJ 08901) for this prospective study. They will be consented by a member of the research team within clinic. All consents and patient data will be stored in a HIPAA-compliant RedCap database. Patients who do not consent to LiSWT but want to participate in the study will be enrolled as a part of the Control group. These patients will also be recruited from a single urological practice as noted above, and consented by a member of the research team within clinic.
Patients who consent to the treatment arm will undergo LiSWT in clinic (typically up to 5,000 shocks per session, up to 6 weekly sessions), administered by study personnel with the MoreNova device (FDA-registered as a class 1 Therapeutic massager). Patients will be assessed for LiSWT complications and for erectile response with validated questionnaires at regular intervals: 1 month, 3 months, 6 months, and 1 year from LiSWT initiation. The patient's insurance will not be billed for the LiSWT sessions, but they will be billed for the follow-up visits. It is typical practice at Rutgers Urology to have any ED patients follow-up at these regular intervals when trialing alternative ED therapies, such as phosphodiesterase-5 inhibitors or intracavernosal injections. These will occur at regular clinic follow-up appointments, either via secure telehealth using the Epic electronic medical record platform or within the clinic. The Sexual Health Inventory for Men (SHIM) is a five-question, abbreviated, validated questionnaire derived from the International Index of Erectile Function questionnaire. It is widely used by urologists to evaluate efficacy of ED treatments. The Erection Hardness Score (EHS) is another tool often used to evaluate and monitor the severity of ED.
Study patients will be compared to control patients with ED who elect for standard therapies and/or lifestyle modifications instead of LiSWT for ED. These control patients will be matched in a 1:1 ratio to the study patients and matched to study patients by age, SHIM and EHS scores, and co-morbidities.
- Conditions
- Erectile Dysfunction
- Being tested
- Low intensity shock wave, Control
- 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 shock waveDevice
Also called MoreNova
6 sessions of low intensity shock wave therapy, applied in 15 minute appointments once weekly.
ControlCombination product
Standard of care treatment: phosphodiesterase 5 inhibitor therapy, vacuum erectile device, constriction bands, intracorporal injections, and penile implant.
| Study group | Role | What they receive |
|---|---|---|
| LiSWT | Experimental | men receiving LiSWT Receives: Device: Low intensity shock wave |
| Control | Active comparator | Standard of care: phosphodiesterase 5 inhibitor therapy, vacuum erectile device, constriction bands, intracorporal injections, penile implant. Receives: Combination Product: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual Health Inventory for Men (SHIM)
The Sexual Health Inventory for Men (SHIM) is a five-question, abbreviated, validated questionnaire derived from the International Index of Erectile Function questionnaire. It is widely used by urologists to evaluate efficacy of ED treatments. It is graded on a scale of 1-25, with higher scores indicating no signs of erectile dysfunction.
Measured: Performed at baseline, and then at each follow-up appointment (3, 6, 12, 24 months)
Secondary outcomes (1)
Erection Hardness Score
The Erection Hardness Score (EHS) is another tool often used to evaluate and monitor the severity of ED. It is a four-point scale (1-4), with a score of 4 indicating a completely hard and fully rigid erection.
Measured: Performed at baseline, and then at each follow-up appointment (3, 6, 12, 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start1 Mar 2025 (estimated)
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 2031 (estimated)
Why it stopped: Institution unable to purchase machine to start study.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danielle Velez Leitner, Rutgers, The State University of New Jersey
- Investigators
- Danielle Velez Leitner, MD, Principal investigator, Rutgers Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469775
- Sponsor's protocol ID
- Pro2023002194
- Status last verified
- Jun 2024
- First submitted
- 17 Jun 2024
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Feldman HA, Goldstein I, Hatzichristou DG, Krane RJ, McKinlay JB. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol. 1994 Jan;151(1):54-61. doi: 10.1016/s0022-5347(17)34871-1.
PubMed 8254833Zanaty F, Badawy A, Kotb H, Elsarfy F, Salman B. Efficacy and safety of low-intensity extracorporeal shock wave therapy versus on-demand tadalafil for erectile dysfunction. Arab J Urol. 2022 Jun 24;20(4):189-194. doi: 10.1080/2090598X.2022.2090134. eCollection 2022.
PubMed 36353469Yao H, Wang X, Liu H, Sun F, Tang G, Bao X, Wu J, Zhou Z, Ma J. Systematic Review and Meta-Analysis of 16 Randomized Controlled Trials of Clinical Outcomes of Low-Intensity Extracorporeal Shock Wave Therapy in Treating Erectile Dysfunction. Am J Mens Health. 2022 Mar-Apr;16(2):15579883221087532. doi: 10.1177/15579883221087532.
PubMed 35319291
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Intensity Shock Wave Therapy for Men With Mild to Moderate Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT06469775
- Acronym / sponsor ID
- Pro2023002194
- Conditions
- Erectile Dysfunction
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Institution unable to purchase machine to start study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Sep 2031 (estimated)
- First posted
- 24 Jun 2024 (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 goal of this a clinical trial to investigate the effect of low-intensity shock wave therapy on patients with erectile function. The main questions it aims to answer are:
- Can low-intensity shock wave therapy (LiSWT) to the penis improve male sexual health, particularly erectile function?
- What is the optimal LiSWT protocol (number of shocks, energy delivered, timeline, etc) for initial and maintenance therapy?
Researchers will compare validated questionnaires on erectile function in men treated with LiSWT compared to men who receive standard of care to see if there is an improvement in erectile function with LiSWT.
Participants will be asked to complete questionnaires at each visit. Those who choose to undergo LiSWT will receive 6 sessions, once per week.
Detailed description
Patients meeting inclusion criteria will be prospectively recruited from a single urological practice (Rutgers Urology, 125 Paterson St. Suite 4100, New Brunswick, NJ 08901) for this prospective study. They will be consented by a member of the research team within clinic. All consents and patient data will be stored in a HIPAA-compliant RedCap database. Patients who do not consent to LiSWT but want to participate in the study will be enrolled as a part of the Control group. These patients will also be recruited from a single urological practice as noted above, and consented by a member of the research team within clinic.
Patients who consent to the treatment arm will undergo LiSWT in clinic (typically up to 5,000 shocks per session, up to 6 weekly sessions), administered by study personnel with the MoreNova device (FDA-registered as a class 1 Therapeutic massager). Patients will be assessed for LiSWT complications and for erectile response with validated questionnaires at regular intervals: 1 month, 3 months, 6 months, and 1 year from LiSWT initiation. The patient's insurance will not be billed for the LiSWT sessions, but they will be billed for the follow-up visits. It is typical practice at Rutgers Urology to have any ED patients follow-up at these regular intervals when trialing alternative ED therapies, such as phosphodiesterase-5 inhibitors or intracavernosal injections. These will occur at regular clinic follow-up appointments, either via secure telehealth using the Epic electronic medical record platform or within the clinic. The Sexual Health Inventory for Men (SHIM) is a five-question, abbreviated, validated questionnaire derived from the International Index of Erectile Function questionnaire. It is widely used by urologists to evaluate efficacy of ED treatments. The Erection Hardness Score (EHS) is another tool often used to evaluate and monitor the severity of ED.
Study patients will be compared to control patients with ED who elect for standard therapies and/or lifestyle modifications instead of LiSWT for ED. These control patients will be matched in a 1:1 ratio to the study patients and matched to study patients by age, SHIM and EHS scores, and co-morbidities.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LiSWT | Experimental | Device: Low intensity shock wavemen receiving LiSWT |
| Control | Active comparator | Combination Product: ControlStandard of care: phosphodiesterase 5 inhibitor therapy, vacuum erectile device, constriction bands, intracorporal injections, penile implant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male sex presenting with mild to severe erectile dysfunction for at least six months, as defined by SHIM score 1-21 and/or an EHS 0-3
- Age >18
- Ability to make independent decisions (sign own consent)
Key exclusion criteria (5 listed)
- Men reliant on penile injections for erections
- Men with current penile implant
- Prisoners
- Current anticoagulant / anti-platelet therapy
- Adults who cannot make their own medical decisions
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 shock waveAlso: MoreNova6 sessions of low intensity shock wave therapy, applied in 15 minute appointments once weekly. | Device | LiSWT |
| ControlStandard of care treatment: phosphodiesterase 5 inhibitor therapy, vacuum erectile device, constriction bands, intracorporal injections, and penile implant. | Combination product | Control |
Primary outcome
Sexual Health Inventory for Men (SHIM)
Time frame: Performed at baseline, and then at each follow-up appointment (3, 6, 12, 24 months)
The Sexual Health Inventory for Men (SHIM) is a five-question, abbreviated, validated questionnaire derived from the International Index of Erectile Function questionnaire. It is widely used by urologists to evaluate efficacy of ED treatments. It is graded on a scale of 1-25, with higher scores indicating no signs of erectile dysfunction.
1 secondary outcome
Erection Hardness Score
Time frame: Performed at baseline, and then at each follow-up appointment (3, 6, 12, 24 months)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Background: PubMed 8254833Feldman HA, Goldstein I, Hatzichristou DG, Krane RJ, McKinlay JB. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol. 1994 Jan;151(1):54-61. doi: 10.1016/s0022-5347(17)34871-1.
- Background: PubMed 36353469Zanaty F, Badawy A, Kotb H, Elsarfy F, Salman B. Efficacy and safety of low-intensity extracorporeal shock wave therapy versus on-demand tadalafil for erectile dysfunction. Arab J Urol. 2022 Jun 24;20(4):189-194. doi: 10.1080/2090598X.2022.2090134. eCollection 2022.
- Background: PubMed 35319291Yao H, Wang X, Liu H, Sun F, Tang G, Bao X, Wu J, Zhou Z, Ma J. Systematic Review and Meta-Analysis of 16 Randomized Controlled Trials of Clinical Outcomes of Low-Intensity Extracorporeal Shock Wave Therapy in Treating Erectile Dysfunction. Am J Mens Health. 2022 Mar-Apr;16(2):15579883221087532. doi: 10.1177/15579883221087532.
- Individual participant dataSharing planned: No
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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.
Danielle Velez Leitner, MD principal investigator
Rutgers Health
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 shock wave in people with Erectile Dysfunction, run by Rutgers, The State University of New Jersey at 1 site in United States.
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 3 inclusion and 5 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: withdrawn, as of the sponsor's last update on 11 Apr 2025. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual Health Inventory for Men (SHIM) (time frame: Performed at baseline, and then at each follow-up appointment (3, 6, 12, 24 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 NCT06469775, 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 11 Apr 2025.