Vasculogenic Erectile DysfunctionNCT03843086
Low Intensity Linear Shockwave Therapy for Erectile Dysfunction
A study testing Low Intensity Linear Shockwave Device for the treatment of Erectile Dysfunction in people with Vasculogenic Erectile Dysfunction, run by University of Virginia.
Trial summary
MoreNovaED is a Linear Shockwaves (LISW) device in which shockwaves are focused onto line segments for improved organ coverage. Shockwaves produced by MoreNovaED are aimed at the left and right corpora cavernosa and the crura. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Vasculogenic Erectile Dysfunction
- What is being tested?
- Low Intensity Linear Shockwave Device for the treatment of Erectile Dysfunction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2019to Mar 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 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient has been correctly informed about the study
- The patient must have given his informed and signed consent
- The patient is a man between 40 and 80 years of age
- The patient has ED of Vasculogenic origin
- The patient is PDE5i responsive, meaning he is able to achieve and maintain an erection under the effect of the maximal dosage of PDE5i
- The patient has been in a stable heterosexual relationship for over 3 months prior to enrollment
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- A minimum of 2 sexual attempts per month for at least one month prior to enrollment
- The patient is suffering from erectile dysfunction lasting for over 6 months and not more than 5 years
- IIEF-EF score between 17 and 25
- Testosterone level 300-1000 ng/dL within 1 month prior to enrollment
- A1C level ≤ 7% within 1 month prior to enrollment
- Patients have at least a natural tumescence during sexual stimulation (EHS score ≥ 1).
Who cannot join
- The patient is participating in another study that may interfere with the results or conclusions of this study
- Within the past three months, the patient has participated in another study that may interfere with the results or conclusions of this study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection
- The patient is an adult under guardianship
- The patient refuses to sign the consent
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- It is impossible to correctly inform the patient
- History of radical prostatectomy or extensive pelvic surgery
- Venous leak
- Past radiation therapy of the pelvic region within 12 months prior to enrollment
- Recovering from cancer within 12 months prior to enrollment
- Neurological disease which effects erectile function
- Psychiatric disease which effects erectile function
- Anatomical malformation of the penis, including Peyronie's disease
- Testosterone level <300 or >1000 ng/dL within 1 month prior to enrollment
- A1C level > 7% within 1 month prior to enrollment
- The patient is taking blood thinners and has an international normalized ratio >3.
About this study
Official title: Safety and Efficacy of Low Intensity Shockwaves for the Treatment of Erectile Dysfunction - Comparison of Two Treatment Schedules
MoreNovaED is a Linear Shockwaves (LISW) device in which shockwaves are focused onto line segments for improved organ coverage. Shockwaves produced by MoreNovaED are aimed at the left and right corpora cavernosa and the crura. The study is aimed at determining the safety and effectiveness of this new type LISW in the relief of ED.
Read the detailed description
Morenova-Erectile dysfunction (ED) is a Linear Shockwaves (LISW) device which incorporates a unique shockwave transducer operable to deliver shockwaves to a treated region confined to a narrow rectangle. Shockwaves generation follows the electromagnetic principle. Low intensity shockwaves do not inflict pain and anesthesia or sedation is not required.
This current study is a prospective, pilot, randomized, uncontrolled clinical study aimed to evaluate the safety and efficacy of the two treatment schedules on symptomatic ED patients. The patients are randomized in a 1:1 ratio into active treatment groups.
Rationale:Linear Shockwaves has been known to bolster angiogenesis by increasing the levels of vascular endothelial growth factor.
- Conditions
- Vasculogenic Erectile Dysfunction
- Being tested
- Low Intensity Linear Shockwave Device for the treatment of Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Intensity Linear Shockwave Device for the treatment of Erectile DysfunctionDevice
Also called MoreNova
This is a prospective, randomized, clinical study aimed to evaluate the safety and efficacy of the two treatment schedules on symptomatic erectile dysfunction patients using low intensity shockwave therapy. The patients are randomized in a 1:1 ratio into two active treatment groups.
Group A: 5 daily sessions within a week (Monday, Tuesday, Wednesday, Thursday, Friday), in which 720 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura).
Group B: Three sessions per week (Monday, Wednesday, Friday) for 2 consecutive weeks, in which 600 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura)
| Study group | Role | What they receive |
|---|---|---|
| 720 Low Intensity shockwave therapy | Active comparator | Five daily sessions within a week, Monday thru Friday, in which 720 shocks of treatment energy applied every session to each treated region (left and right corpora cavernosa and crura) Receives: Device: Low Intensity Linear Shockwave Device for the treatment of Erectile Dysfunction |
| 600 Low Intensity shockwaves therapy | Active comparator | Three weekly sessions for 2 consecutive weeks, Monday-Wednesday-Friday, in which 600 shocks of treatment energy applied every session to each treated region (left and right corpora cavernosa and crura)
Following the last treatment session, each patient will resume his baseline consumption of phosphodiesterase 5 inhibitor in terms of type and dose of drug, for the remainder of study duration. Receives: Device: Low Intensity Linear Shockwave Device for the treatment of Erectile Dysfunction |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Index of Erectile Function (IIEF-EF) Questionnaire
The 15-question International Index of Erectile Function (IIEF) Questionnaire is a validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials
Measured: 7 months
Secondary outcomes (3)
SEP (Sexual Encounter Profile) 2 & 3 at follow-ups
Sexual activity improvement leading to optimal penetration at follow-ups. 2 Yes or No questions
Measured: 7 months
GAQ (Global Assessment Questions) at follow-ups
2 Yes or No questions assessing improvement with treatment
Measured: 7 months
EHS (Erection Hardness Score) at follow-ups
Scale rating hardness of erection from 0-4 with 4 being highest
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study startJun 2019 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionMar 2022 (estimated)
Why it stopped: Change in device and protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasculogenic 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- DIREX SYSTEMS CORPORATION
- Responsible party
- Principal investigator, Ryan Smith, MD, University of Virginia
- Investigators
- Ryan P Smith, M.D., Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843086
- Sponsor's protocol ID
- 21221
- Status last verified
- May 2022
- First submitted
- 28 Jan 2019
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Low Intensity Shockwaves for the Treatment of Erectile Dysfunction - Comparison of Two Treatment Schedules
- ClinicalTrials.gov ID
- NCT03843086
- Acronym / sponsor ID
- 21221
- Conditions
- Vasculogenic Erectile Dysfunction
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in device and protocol
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- DIREX SYSTEMS CORPORATION
- Study start
- Jun 2019 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 15 Feb 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.
MoreNovaED is a Linear Shockwaves (LISW) device in which shockwaves are focused onto line segments for improved organ coverage. Shockwaves produced by MoreNovaED are aimed at the left and right corpora cavernosa and the crura. The study is aimed at determining the safety and effectiveness of this new type LISW in the relief of ED.
Detailed description
Morenova-Erectile dysfunction (ED) is a Linear Shockwaves (LISW) device which incorporates a unique shockwave transducer operable to deliver shockwaves to a treated region confined to a narrow rectangle. Shockwaves generation follows the electromagnetic principle. Low intensity shockwaves do not inflict pain and anesthesia or sedation is not required.
This current study is a prospective, pilot, randomized, uncontrolled clinical study aimed to evaluate the safety and efficacy of the two treatment schedules on symptomatic ED patients. The patients are randomized in a 1:1 ratio into active treatment groups.
Rationale:Linear Shockwaves has been known to bolster angiogenesis by increasing the levels of vascular endothelial growth factor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 720 Low Intensity shockwave therapy | Active comparator | Device: Low Intensity Linear Shockwave Device for the treatment of Erectile DysfunctionFive daily sessions within a week, Monday thru Friday, in which 720 shocks of treatment energy applied every session to each treated region (left and right corpora cavernosa and crura) |
| 600 Low Intensity shockwaves therapy | Active comparator | Device: Low Intensity Linear Shockwave Device for the treatment of Erectile DysfunctionThree weekly sessions for 2 consecutive weeks, Monday-Wednesday-Friday, in which 600 shocks of treatment energy applied every session to each treated region (left and right corpora cavernosa and crura) Following the last treatment session, each patient will resume his baseline consumption of phosphodiesterase 5 inhibitor in terms of type and dose of drug, for the remainder of study duration. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- The patient has been correctly informed about the study
- The patient must have given his informed and signed consent
- The patient is a man between 40 and 80 years of age
- The patient has ED of Vasculogenic origin
- The patient is PDE5i responsive, meaning he is able to achieve and maintain an erection under the effect of the maximal dosage of PDE5i
Key exclusion criteria (17 listed)
- The patient is participating in another study that may interfere with the results or conclusions of this study
- Within the past three months, the patient has participated in another study that may interfere with the results or conclusions of this study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection
- The patient is an adult under guardianship
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 Linear Shockwave Device for the treatment of Erectile DysfunctionAlso: MoreNovaThis is a prospective, randomized, clinical study aimed to evaluate the safety and efficacy of the two treatment schedules on symptomatic erectile dysfunction patients using low intensity shockwave therapy. The patients are randomized in a 1:1 ratio into two active treatment groups. Group A: 5 daily sessions within a week (Monday, Tuesday, Wednesday, Thursday, Friday), in which 720 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura). Group B: Three sessions per week (Monday, Wednesday, Friday) for 2 consecutive weeks, in which 600 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura) | Device | 600 Low Intensity shockwaves therapy, 720 Low Intensity shockwave therapy |
Primary outcome
International Index of Erectile Function (IIEF-EF) Questionnaire
Time frame: 7 months
The 15-question International Index of Erectile Function (IIEF) Questionnaire is a validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials
3 secondary outcomes
SEP (Sexual Encounter Profile) 2 & 3 at follow-ups
Time frame: 7 months
GAQ (Global Assessment Questions) at follow-ups
Time frame: 7 months
EHS (Erection Hardness Score) at follow-ups
Time frame: 7 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 25 May 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Vasculogenic Erectile Dysfunction
RecruitingObservational study
Endothelial Markers and Tadalafil Response
Vasculogenic Erectile Dysfunction
Not yet recruiting
The Feasibility of Using Dornier Machine in Patients With Erectile Dysfunction, a Pilot Study.
Erectile Dysfunction (ED)
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.
Ryan P Smith, M.D. principal investigator
University of Virginia
Questions about this trial
What is this clinical trial studying?
A study testing Low Intensity Linear Shockwave Device for the treatment of Erectile Dysfunction in people with Vasculogenic Erectile Dysfunction, run by University of Virginia.
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 12 inclusion and 17 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 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
International Index of Erectile Function (IIEF-EF) Questionnaire (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 May 2022.