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Researchers are evaluating the efficacy of low intensity shockwave therapy (LISWT) via MoreNova in the treatment of erectile dysfunction (ED).
ED is broadly defined as the inability to achieve or maintain an erection sufficient for sexual intercourse or activity. Current treatment for ED consists of oral medications, intracavernosal injections and surgically placed penile prosthetics. In the literature this has been described as a Stepwise Approach, offering therapy beginning with the least invasive treatment option.
The goal of LISWT is to restore natural erections and / or improve responses to oral medications (first line therapy).
LISWT for ED is under evaluation in the USA. The European Association of Urology Guidelines on ED were recently updated to include LISWT for men with mild to moderate ED. The energy/pulse used in this application is approximately 10% of the energy used for disintegrating kidney stones; no serious side effects have been reported. Shock wave therapy for diabetic ulcers has recently been approved by the FDA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Males with erectile dysfunction (ED) | Experimental | Males diagnosed with erectile dysfunction (ED) for over a year, but less than 5 years, will receive shock wave therapy via MoreNova device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MoreNova | Device | Shockwave therapy delivered to the genital area with low dose shocks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Right Resistive Index | Resistive Index (RI) is a measure of resistance to blood flow within the right penile arteries. Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second Elevated values are associated with a poorer prognosis. Lower values are associated with a better prognosis. | Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour |
| Change in Right Peak Systolic Velocity | Peak systolic velocity (PSV): The maximum velocity of blood flow during erection. Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second A PSV higher than 35 cm/sec is regarded as normal, a 25-35 cm/sec may indicate moderate-to-mean arterial damage, and a PSV lower than 25 may indicate the presence of severe arteriopathy. | Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour |
| Change in Right Diastolic Velocity | Diastolic Velocity (DV) represents the velocity of right-side blood flow during the resting phase of the cardiac cycle. A DV less than 5 cm/s is considered normal (better). A DV less considered abnormal (worse). Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second | Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour |
| Erection Hardness Score (EHS) | Measured using a self-reported Erection Hardness Score (EHS) scale options from 0 (minimum) to 4 (maximum). 0- Penis does not enlarge, 1- Penis is larger but not hard, 2- Penis is hard but not hard enough for penetration, 3- Penis is hard enough for penetration but not completely hard, or 4-Penis is completely hard and fully rigid. A lower score indicates a worse outcome. A higher score indicates a better outcome. | Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory Broderick, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Males With Erectile Dysfunction (ED) | Males diagnosed with erectile dysfunction (ED) for over a year, but less than 5 years, will receive shock wave therapy via MoreNova device MoreNova: Shockwave therapy delivered to the genital area with low dose shocks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Males With Erectile Dysfunction (ED) | Males diagnosed with erectile dysfunction (ED) for over a year, but less than 5 years, will receive shock wave therapy via MoreNova device MoreNova: Shockwave therapy delivered to the genital area with low dose shocks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Right Resistive Index | Resistive Index (RI) is a measure of resistance to blood flow within the right penile arteries. Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second Elevated values are associated with a poorer prognosis. Lower values are associated with a better prognosis. | Posted | Mean | Full Range | cm/second | Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour |
|
4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Males With Erectile Dysfunction (ED) | Males diagnosed with erectile dysfunction (ED) for over a year, but less than 5 years, will receive shock wave therapy via MoreNova device MoreNova: Shockwave therapy delivered to the genital area with low dose shocks |
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The Covid-19 Pandemic was a limitation during the trial. The pandemic interfered with recruitment and follow-up of study subjects.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chandler Chapman, DHSc, MPH, Senior Clinical Research Coordinator | Mayo Clinic | 9049538681 | Chapman.Chandler@mayo.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 10, 2019 | Jul 30, 2024 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| International Index of Erectile Function (IIEF - EF) Questionnaire | Measured using a self-reported International Index of Erectile Function questionnaire (IIEF - EF) consisting of 6 questions regarding the participants erectile function for the past 4 weeks. The questionnaire utilizes a scale of 0 (minimum) to 5 (maximum). A lower score indicates a worse outcome. A higher score indicates a better outcome. Questions 1-2 scale: 0=No sexual activity, 1= Almost never/never, 2= A few times (much less than half the time),3= Sometimes (about half the time), 4= Most times (much more than half the time),5= Almost always/always Questions 3-4 scale: 0=Did not attempt, 1=Almost never/never, 2= A few times (much less than half the time), 3= Sometimes (about half the time), 4= Most times (much more than half the time), 5= Almost always/always Question 5 scale:0=Did not attempt intercourse,1= Extremely difficult, 2=Very Difficult, 3=Difficult, 4= Slightly Difficult, 5= No Difficult Question 6 scale: 1= Very low, 2=Low, 3=Moderate, 4=High, 5= Very high | Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour |
| Sexual Encounter Profile (SEP) Questionnaire | Measured using a self-reported Sexual Encounter Profile (SEP) Questionnaire consisting of 2 questions. The questionnaire utilized Yes or No response options. No, indicates a worse outcome. Yes, indicates a better outcome. | Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour |
| Global Assessment Questionnaire | Measured using a self-reported Global Assessment Questionnaire consisting of 2 questions. The questionnaire utilized Yes or No response options. No, indicates a worse outcome. Yes, indicates a better outcome. | Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour |
| Change in Left Peak Systolic Velocity | Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second A Peak Systolic Velocity of 25-35 cm/s or higher is considered normal. This reflects the maximum velocity of blood flow during erection. | Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour |
| Change in Left Diastolic Velocity | Diastolic Velocity (DV) represents the velocity of left-side blood flow during the resting phase of the cardiac cycle. A DV less than 5 cm/s is considered normal (better). A DV less considered abnormal (worse). Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second | Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour |
| Left Resistive Index | Resistive Index (RI) is a measure of resistance to blood flow within the left penile arteries. Measured Left Resistive Index using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second Elevated values are associated with poorer prognosis. Lower values are associated with a better prognosis. | Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Full Range | kg/m^2 |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Change in Right Peak Systolic Velocity | Peak systolic velocity (PSV): The maximum velocity of blood flow during erection. Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second A PSV higher than 35 cm/sec is regarded as normal, a 25-35 cm/sec may indicate moderate-to-mean arterial damage, and a PSV lower than 25 may indicate the presence of severe arteriopathy. | Posted | Mean | Full Range | cm/second | Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour |
|
|
|
| Primary | Change in Right Diastolic Velocity | Diastolic Velocity (DV) represents the velocity of right-side blood flow during the resting phase of the cardiac cycle. A DV less than 5 cm/s is considered normal (better). A DV less considered abnormal (worse). Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second | Posted | Mean | Full Range | cm/second | Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour |
|
|
|
| Primary | Erection Hardness Score (EHS) | Measured using a self-reported Erection Hardness Score (EHS) scale options from 0 (minimum) to 4 (maximum). 0- Penis does not enlarge, 1- Penis is larger but not hard, 2- Penis is hard but not hard enough for penetration, 3- Penis is hard enough for penetration but not completely hard, or 4-Penis is completely hard and fully rigid. A lower score indicates a worse outcome. A higher score indicates a better outcome. | Posted | Number | participants | Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour |
|
|
|
| Primary | International Index of Erectile Function (IIEF - EF) Questionnaire | Measured using a self-reported International Index of Erectile Function questionnaire (IIEF - EF) consisting of 6 questions regarding the participants erectile function for the past 4 weeks. The questionnaire utilizes a scale of 0 (minimum) to 5 (maximum). A lower score indicates a worse outcome. A higher score indicates a better outcome. Questions 1-2 scale: 0=No sexual activity, 1= Almost never/never, 2= A few times (much less than half the time),3= Sometimes (about half the time), 4= Most times (much more than half the time),5= Almost always/always Questions 3-4 scale: 0=Did not attempt, 1=Almost never/never, 2= A few times (much less than half the time), 3= Sometimes (about half the time), 4= Most times (much more than half the time), 5= Almost always/always Question 5 scale:0=Did not attempt intercourse,1= Extremely difficult, 2=Very Difficult, 3=Difficult, 4= Slightly Difficult, 5= No Difficult Question 6 scale: 1= Very low, 2=Low, 3=Moderate, 4=High, 5= Very high | Posted | Count of Participants | Participants | Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour |
|
|
|
| Primary | Sexual Encounter Profile (SEP) Questionnaire | Measured using a self-reported Sexual Encounter Profile (SEP) Questionnaire consisting of 2 questions. The questionnaire utilized Yes or No response options. No, indicates a worse outcome. Yes, indicates a better outcome. | Posted | Count of Participants | Participants | Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour |
|
|
|
| Primary | Global Assessment Questionnaire | Measured using a self-reported Global Assessment Questionnaire consisting of 2 questions. The questionnaire utilized Yes or No response options. No, indicates a worse outcome. Yes, indicates a better outcome. | Posted | Count of Participants | Participants | Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour |
|
|
|
| Primary | Change in Left Peak Systolic Velocity | Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second A Peak Systolic Velocity of 25-35 cm/s or higher is considered normal. This reflects the maximum velocity of blood flow during erection. | Posted | Mean | Full Range | cm/second | Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour |
|
|
|
| Primary | Change in Left Diastolic Velocity | Diastolic Velocity (DV) represents the velocity of left-side blood flow during the resting phase of the cardiac cycle. A DV less than 5 cm/s is considered normal (better). A DV less considered abnormal (worse). Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second | Posted | Mean | Full Range | cm/second | Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour |
|
|
|
| Primary | Left Resistive Index | Resistive Index (RI) is a measure of resistance to blood flow within the left penile arteries. Measured Left Resistive Index using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second Elevated values are associated with poorer prognosis. Lower values are associated with a better prognosis. | Posted | Mean | Full Range | cm/second | Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour |
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| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
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| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| Title | Measurements |
|---|---|
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| Number of participants who answered 3 on scale. |
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| Number of participants who answered 4 on scale. |
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| 3 |
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| 4 |
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| 5 |
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| When you had erections with stimulation, how often were your erections hard enough for penetration? |
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| When you attempted sexual intercourse, how often were you able to penetrate your partner? |
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| During intercourse,how often were you able to maintain your erection after you entered your partner? |
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| During intercourse, how difficult was it to maintain your erection to completion of intercourse? |
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| How would you rate your confidence that you could get and keep an erection? |
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| Answered No |
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| Q2: Has the treatment improved your ability to engage in sexual activity over the past 4 weeks? |
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