Vasculogenic Erectile DysfunctionNCT03067987
Safety and Efficacy of Low Intensity Shockwave for the Treatment of 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 Miami at 1 site in United States.
Trial summary
Renova- Erectile Dysfunction (ED) is a Linear Shockwaves (LISW) device which incorporates a unique shockwave transducer operable to deliver shockwaves to a treated region. Shockwaves are aimed at the left and right corpora cavernosa and the crura. Read more about this study
- Who is it for?
- Ages 30 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
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2017to 28 May 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must be willing and able to provide informed consent.
- The patient is a male between >30 and <80 years of age.
- PDE5i responsive or non-responsive. If on PDE5i patient will discontinue medication for 4 weeks before IIEF.
- Stable sexual relationship for over 3 months prior to enrollment.
- A minimum of 2 sexual attempts per month for at least one month prior to enrollment.
- Erectile dysfunction lasting for over 6 months and not more than 5 years.
Show all 9Show fewer
- Baseline IIEF-EF score between 11 and 25. If taking PDE5i, stop medication for at least 4 weeks before baseline IIEF-EF.
- Testosterone level 300-1000 ng/dL.
- If diabetic, HgbA1C level ≤ 7.5% within 1 month prior to enrollment.
Who cannot join
- The patient is currently or has participated in another study within the past three months, that may interfere with the results or conclusions of this study.
- The patient is under judicial protection (prison or custody).
- The patient is an adult under guardianship.
- The patient refuses to sign the consent.
- History of radical prostatectomy or extensive pelvic surgery ever.
- Past radiation therapy of the pelvic region within 12 months prior to enrollment.
Show all 15Show fewer
- Recovering from any cancer within 12 months prior to enrollment.
- Neurological disease such as Alzheimers or Parkinsons disease which affects erectile function at the discretion of the investigator.
- Psychiatric diagnosis or medications such as antidepressants which affects erectile function or any other medications at the discretion of the investigator.
- Anatomical malformation of the penis, including Peyronie's disease.
- Testosterone level <300 or >1000 ng/dL within 1 month prior to enrollment.
- HgbA1C level > 7.5% within 1 month prior to enrollment.
- Androgen deprivation treatment in the last year.
- History of spinal cord injury.
- The patient is taking blood thinners (eg Coumadin, Plavix)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Low Intensity Shockwave for the Treatment of Erectile Dysfunction- Comparison of Two Treatment Schedule
Renova- Erectile Dysfunction (ED) is a Linear Shockwaves (LISW) device which incorporates a unique shockwave transducer operable to deliver shockwaves to a treated region. Shockwaves 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 erectile dysfunction.
HYPOTHESIS Alternate Hypothesis (HA): Active Treatment groups will show a >2-point increase in the IIEF-EF score from baseline for mild erectile dysfunction, and >5 points for moderate erectile dysfunction and will show significant change.
Read more
Null Hypothesis (HO): There is no difference from baseline and after-treatment in Treatment groups for alleviating erectile dysfunction measured using International Index of Erectile Function score (IIEF-EF).
Primary Efficacy Objective: To evaluate change of International Index of Erectile Function score Questionnaire score from baseline to follow-ups 1, 3 and 6 months' post treatment.
Secondary Objectives:To study sexual activity improvement leading to optimal penetration at follow-ups according to:
- SEP- Sexual Encounter Profile Questionnaire.
- GAQ- Global Assessment Questionnaire.
- EHS- Erection Hardness Score.
Read the detailed description
Renova-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.
Linear Shockwaves (LISW), as a treatment for erectile dysfunction has been in evaluation in contemporary medicine, It has been in use for the last three years.
The present study is about a device called "Renova-erectile dysfunction", in which shockwaves are focused onto line segments for improved organ coverage. Shockwaves produced by "Renova-erectile dysfunction" 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 erectile dysfunction.
Rationale:Linear Shockwaves has been known to bolster angiogenesis by increasing the levels of vascular endothelial growth factor.
Principal mode of action used in other disease:
- Coronary Artery Disease: Kikuchi et al.3 showed significantly improved symptoms and decreased nitroglycerin use in patient who had a coronary artery bypass grafting and were suffering from stable angina.
- Bone Healing: Haupt et al.4 showed that Low intensity shock waves treated group showed radiological signs of faster healing.
- Calcifying tendinitis: Rompe et al.5 showed that shock wave to patient suffering from calcifying tendinitis showed a 62.5% partial and complete disintegration of the the deposits. Moreover, 85% of the patients reported improvement at 24-week follow up period.
- Diabetic Foot Ulcers: Wang et al.6 showed that Extracorporeal Shock Wave Therapy (ESWT) to patients with diabetic foot ulcer showed complete improvement in 31% and partial improvement in 58%.Moreover,Extracorporeal Shock Wave Therapy showed significantly better clinical results and local blood flow perfusion, higher cell concentration, and activity than the Hyperbaric Oxygen group.
Preliminary Studies:
Contemporary literature shows two important studies in this field both conducted by Verdi et al.
The efficacy trial study published in 2010 recruited 20 men with vasculogenic erectile dysfunction and were given serial 2 sessions of treatment for about 3 weeks followed by 3 - week no intervention period. At 1-month duration there was a significant improvement in their erectile function measured by International Index of Erectile Function domain scores (20.9 5.8 vs 13.5 4.1, p < 0.001). This significant result was consistent at 6-month follow up. Moreover, no pain or adverse event was noted during the follow-up period.
The second randomized, double-blind, sham controlled study by showed that treatment group showed better outcome than control group measured using International Index of Erectile Function-Erectile Function domain (mean square root of sample size 6.7 0.9 vs 3.0 1.4, p 0.0322) at the first follow-up. Additionally, penile hemodynamics improve significantly in the treatment group in comparison to control group (maximal post-ischemic penile blood flow 8.2 vs 0.1 ml per minute per dl, p 0.0001).
Primary Efficacy Objective:To evaluate change of Erectile Function-Erectile Function score 9 from baseline to follow-ups 1, 3 and 6 months' post treatment.
Secondary Objectives:To study sexual activity improvement leading to optimal penetration at follow-ups according to:
- SEP- Sexual Encounter Profile.
- GAQ- Global Assessment Questions.
- EHS- Erection Hardness Score.
STUDY DESIGN Accrual goal: A total of 80 patients with Vasculogenic erectile dysfunction meeting the eligibility criteria will be recruited from the Department of Urology clinic.
Duration of Study Participation: The total duration of the study will be for 7 months- including 1-month pretreatment (washout) followed by a period of 6 months' follow-up after the treatment.
Screening Evaluations and Procedures: The first visit of the patients will be for screening and medical evaluation. Patient's medical co-medication history will be collected and documented and a physical examination will be performed.
Previous month's blood test results will be reviewed including a general chemistry panel, a lipid profile, hemoglobin A1C and testosterone levels during chart review.
Patients will sign an informed consent and will answer the Erectile Function-Erectile Function questionnaire to see if they fit the criteria for enrollment. In case they meet all inclusion criteria (and do not meet any exclusion criteria), they will be recruited to the study.
Patients who have been using phosphodiesterase 5 inhibitor (PDE5-i) in the last 4 weeks will report on their medicine type and dosage, and this data will be recorded in their files (reported prior to consent and gathered from chart review).
Pre-Treatment Procedures and Evaluations : Upon evaluating the inclusion/exclusion criteria, patients will be recruited to the study and randomized into one of the two groups in a 1:1 ratio (randomization will be performed by a computer software maintained by the Department of Urology). Patients randomized to the treatment groups will be instructed to stop any use of phosphodiesterase 5 inhibitor for 4 weeks prior to first treatment session and refrain from using any other erectile dysfunction therapy option during the study. They will be instructed to undergo a phosphodiesterase 5 inhibitor washout period of 4 weeks prior to treatment and to avoid using phosphodiesterase 5 inhibitor or any other erectile dysfunction treatment during the entire study duration (shockwave treatment and follow-ups). After the washout period and before the first treatment session, patients will answer the IIEF-EF, SEP and EHS questionnaires for baseline evaluation.
Treatment procedure: The treatment session lasts approximately 20 minutes and may be performed in an office environment. Treatment is applied in the physician's office. For session and treatment details (see below)
During the treatment, the same total number of shocks will be delivered according to the two treatment schedules as follows:
Group A:
5 daily sessions within a week (Monday, Tuesday, Wednesday, Thursday, Friday (MTWThF), 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 (MWF) 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)
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.
Follow-Up Procedures and Evaluations:Follow-up visits will be conducted at month 1, month 3 and month 6 after the last treatment session and shall include:
Measuring IIEF-EF, GAQ, SEP, and EHS scores of patients at the clinic at every follow-up visit
Reporting and recording adverse events at every follow-up visit.
- 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 Dysfunction.Device
Also called RENOVA-ED
This is a prospective, randomized, clinical study aimed to evaluate the safety and efficacy of the two treatment schedules on symptomatic erectile dysfunction patients. 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 shockwave therapy | Active comparator | 5 daily sessions of shockwave therapy 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). Receives: Device: Low Intensity Linear Shockwave Device for the Treatment of Erectile Dysfunction. |
| 600 shockwave therapy | Active comparator | Three sessions of shockwave therapy 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)
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
IIEF is a 15 item self-administered questionnaire assessing erectile dysfunction and treatment outcomes. Total IIEF score range from 5-25 with scores classifying erectile dysfunction (ED) as: severe (5-7); moderate (8-11); mild to moderate (12-16); mild (17-21) and no ED (22-25). The questionnaire will be assessed at baseline (before 1 month washout prior to treatment initiation), 1 month follow up (at 2 months), 3 month follow up (at 4 months) and 6 months follow up (at 7 months).
Time Frame: 7 months
Measured: 7 months
Secondary outcomes (3)
Erection Hardness Score (EHS)
EHS rates the hardness of erection on a scale of 1-4 assessed at baseline (before 1 month washout prior to treatment initiation), 1 month follow up (at 2 months), 3 month follow up (at 4 months) and 6 months follow up (at 7 months). A score of 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; 4 = penis is completely hard and fully rigid.
Measured: 7 months
Sexual Encounter Profile (SEP)
Sexual Encounter Profile (SEP) is a measure of efficacy of erectile dysfunction therapy. Improved responses to treatment will be reported as the percentage of participants that responds "yes" and non-improvement responses to treatment will be reported as the percentage of participants that responds "no".
Measured: 7 months
Global Assessment Question (GAQ)
Global Assessment Question (GAQ) is a measure of perceived improvements in erectile function and sexual ability. Improved responses to treatment will be reported as the percentage of participants that responds "yes" and non-improvement responses to treatment will be reported as the percentage of participants that responds "no".
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 posted1 Mar 2017
- Study start22 Feb 2017
- Primary completion22 May 2019
- Study completion28 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Vasculogenic Erectile DysfunctionStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- DIREX SYSTEMS CORPORATION
- Responsible party
- Principal investigator, Ranjith Ramasamy, MD, University of Miami
- Investigators
- Ranjith Ramasamy, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03067987
- Sponsor's protocol ID
- 20160335
- Status last verified
- May 2020
- First submitted
- 23 Feb 2017
- Last updated
- 11 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Mulhall JP. Defining and reporting erectile function outcomes after radical prostatectomy: challenges and misconceptions. J Urol. 2009 Feb;181(2):462-71. doi: 10.1016/j.juro.2008.10.047. Epub 2008 Dec 13.
PubMed 19084865Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology. 1997 Jun;49(6):822-30. doi: 10.1016/s0090-4295(97)00238-0.
PubMed 9187685Vardi Y, Appel B, Kilchevsky A, Gruenwald I. Does low intensity extracorporeal shock wave therapy have a physiological effect on erectile function? Short-term results of a randomized, double-blind, sham controlled study. J Urol. 2012 May;187(5):1769-75. doi: 10.1016/j.juro.2011.12.117. Epub 2012 Mar 15.
PubMed 22425129Vardi Y, Appel B, Jacob G, Massarwi O, Gruenwald I. Can low-intensity extracorporeal shockwave therapy improve erectile function? A 6-month follow-up pilot study in patients with organic erectile dysfunction. Eur Urol. 2010 Aug;58(2):243-8. doi: 10.1016/j.eururo.2010.04.004. Epub 2010 May 6.
PubMed 20451317Wang CJ, Kuo YR, Wu RW, Liu RT, Hsu CS, Wang FS, Yang KD. Extracorporeal shockwave treatment for chronic diabetic foot ulcers. J Surg Res. 2009 Mar;152(1):96-103. doi: 10.1016/j.jss.2008.01.026. Epub 2008 Mar 7.
PubMed 18619622Rompe JD, Rumler F, Hopf C, Nafe B, Heine J. Extracorporal shock wave therapy for calcifying tendinitis of the shoulder. Clin Orthop Relat Res. 1995 Dec;(321):196-201.
PubMed 7497669Haupt G, Haupt A, Ekkernkamp A, Gerety B, Chvapil M. Influence of shock waves on fracture healing. Urology. 1992 Jun;39(6):529-32. doi: 10.1016/0090-4295(92)90009-l.
PubMed 1615601Kikuchi Y, Ito K, Ito Y, Shiroto T, Tsuburaya R, Aizawa K, Hao K, Fukumoto Y, Takahashi J, Takeda M, Nakayama M, Yasuda S, Kuriyama S, Tsuji I, Shimokawa H. Double-blind and placebo-controlled study of the effectiveness and safety of extracorporeal cardiac shock wave therapy for severe angina pectoris. Circ J. 2010 Mar;74(3):589-91. doi: 10.1253/circj.cj-09-1028. Epub 2010 Feb 4.
PubMed 20134096Melman A, Gingell JC. The epidemiology and pathophysiology of erectile dysfunction. J Urol. 1999 Jan;161(1):5-11.
PubMed 10037356Vlachopoulos C, Rokkas K, Ioakeimidis N, Aggeli C, Michaelides A, Roussakis G, Fassoulakis C, Askitis A, Stefanadis C. Prevalence of asymptomatic coronary artery disease in men with vasculogenic erectile dysfunction: a prospective angiographic study. Eur Urol. 2005 Dec;48(6):996-1002; discussion 1002-3. doi: 10.1016/j.eururo.2005.08.002. Epub 2005 Aug 24.
PubMed 16174548Katz JE, Molina ML, Clavijo R, Prakash NS, Ramasamy R. A Phase 2 Randomized Trial To Evaluate Different Dose Regimens of Low-intensity Extracorporeal Shockwave Therapy for Erectile Dysfunction: Clinical Trial Update. Eur Urol Focus. 2018 Apr;4(3):336-337. doi: 10.1016/j.euf.2018.07.011. Epub 2018 Jul 17.
PubMed 30025713
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Low Intensity Shockwave for the Treatment of Erectile Dysfunction- Comparison of Two Treatment Schedule
- ClinicalTrials.gov ID
- NCT03067987
- Acronym / sponsor ID
- 20160335
- Conditions
- Vasculogenic Erectile Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- DIREX SYSTEMS CORPORATION
- Study start
- 22 Feb 2017 (actual)
- Primary completion
- 22 May 2019 (actual)
- Study completion
- 28 May 2019 (actual)
- First posted
- 1 Mar 2017 (actual)
- Results
- Posted 11 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Renova- Erectile Dysfunction (ED) is a Linear Shockwaves (LISW) device which incorporates a unique shockwave transducer operable to deliver shockwaves to a treated region. Shockwaves 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 erectile dysfunction.
HYPOTHESIS Alternate Hypothesis (HA): Active Treatment groups will show a >2-point increase in the IIEF-EF score from baseline for mild erectile dysfunction, and >5 points for moderate erectile dysfunction and will show significant change.
Null Hypothesis (HO): There is no difference from baseline and after-treatment in Treatment groups for alleviating erectile dysfunction measured using International Index of Erectile Function score (IIEF-EF).
Primary Efficacy Objective: To evaluate change of International Index of Erectile Function score Questionnaire score from baseline to follow-ups 1, 3 and 6 months' post treatment.
Secondary Objectives:To study sexual activity improvement leading to optimal penetration at follow-ups according to:
- SEP- Sexual Encounter Profile Questionnaire.
- GAQ- Global Assessment Questionnaire.
- EHS- Erection Hardness Score.
Detailed description
Renova-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.
Linear Shockwaves (LISW), as a treatment for erectile dysfunction has been in evaluation in contemporary medicine, It has been in use for the last three years.
The present study is about a device called "Renova-erectile dysfunction", in which shockwaves are focused onto line segments for improved organ coverage. Shockwaves produced by "Renova-erectile dysfunction" 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 erectile dysfunction.
Rationale:Linear Shockwaves has been known to bolster angiogenesis by increasing the levels of vascular endothelial growth factor.
Principal mode of action used in other disease:
- Coronary Artery Disease: Kikuchi et al.3 showed significantly improved symptoms and decreased nitroglycerin use in patient who had a coronary artery bypass grafting and were suffering from stable angina.
- Bone Healing: Haupt et al.4 showed that Low intensity shock waves treated group showed radiological signs of faster healing.
- Calcifying tendinitis: Rompe et al.5 showed that shock wave to patient suffering from calcifying tendinitis showed a 62.5% partial and complete disintegration of the the deposits. Moreover, 85% of the patients reported improvement at 24-week follow up period.
- Diabetic Foot Ulcers: Wang et al.6 showed that Extracorporeal Shock Wave Therapy (ESWT) to patients with diabetic foot ulcer showed complete improvement in 31% and partial improvement in 58%.Moreover,Extracorporeal Shock Wave Therapy showed significantly better clinical results and local blood flow perfusion, higher cell concentration, and activity than the Hyperbaric Oxygen group.
Preliminary Studies:
Contemporary literature shows two important studies in this field both conducted by Verdi et al.
The efficacy trial study published in 2010 recruited 20 men with vasculogenic erectile dysfunction and were given serial 2 sessions of treatment for about 3 weeks followed by 3 - week no intervention period. At 1-month duration there was a significant improvement in their erectile function measured by International Index of Erectile Function domain scores (20.9 5.8 vs 13.5 4.1, p < 0.001). This significant result was consistent at 6-month follow up. Moreover, no pain or adverse event was noted during the follow-up period.
The second randomized, double-blind, sham controlled study by showed that treatment group showed better outcome than control group measured using International Index of Erectile Function-Erectile Function domain (mean square root of sample size 6.7 0.9 vs 3.0 1.4, p 0.0322) at the first follow-up. Additionally, penile hemodynamics improve significantly in the treatment group in comparison to control group (maximal post-ischemic penile blood flow 8.2 vs 0.1 ml per minute per dl, p 0.0001).
Primary Efficacy Objective:To evaluate change of Erectile Function-Erectile Function score 9 from baseline to follow-ups 1, 3 and 6 months' post treatment.
Secondary Objectives:To study sexual activity improvement leading to optimal penetration at follow-ups according to:
- SEP- Sexual Encounter Profile.
- GAQ- Global Assessment Questions.
- EHS- Erection Hardness Score.
STUDY DESIGN Accrual goal: A total of 80 patients with Vasculogenic erectile dysfunction meeting the eligibility criteria will be recruited from the Department of Urology clinic.
Duration of Study Participation: The total duration of the study will be for 7 months- including 1-month pretreatment (washout) followed by a period of 6 months' follow-up after the treatment.
Screening Evaluations and Procedures: The first visit of the patients will be for screening and medical evaluation. Patient's medical co-medication history will be collected and documented and a physical examination will be performed.
Previous month's blood test results will be reviewed including a general chemistry panel, a lipid profile, hemoglobin A1C and testosterone levels during chart review.
Patients will sign an informed consent and will answer the Erectile Function-Erectile Function questionnaire to see if they fit the criteria for enrollment. In case they meet all inclusion criteria (and do not meet any exclusion criteria), they will be recruited to the study.
Patients who have been using phosphodiesterase 5 inhibitor (PDE5-i) in the last 4 weeks will report on their medicine type and dosage, and this data will be recorded in their files (reported prior to consent and gathered from chart review).
Pre-Treatment Procedures and Evaluations : Upon evaluating the inclusion/exclusion criteria, patients will be recruited to the study and randomized into one of the two groups in a 1:1 ratio (randomization will be performed by a computer software maintained by the Department of Urology). Patients randomized to the treatment groups will be instructed to stop any use of phosphodiesterase 5 inhibitor for 4 weeks prior to first treatment session and refrain from using any other erectile dysfunction therapy option during the study. They will be instructed to undergo a phosphodiesterase 5 inhibitor washout period of 4 weeks prior to treatment and to avoid using phosphodiesterase 5 inhibitor or any other erectile dysfunction treatment during the entire study duration (shockwave treatment and follow-ups). After the washout period and before the first treatment session, patients will answer the IIEF-EF, SEP and EHS questionnaires for baseline evaluation.
Treatment procedure: The treatment session lasts approximately 20 minutes and may be performed in an office environment. Treatment is applied in the physician's office. For session and treatment details (see below)
During the treatment, the same total number of shocks will be delivered according to the two treatment schedules as follows:
Group A:
5 daily sessions within a week (Monday, Tuesday, Wednesday, Thursday, Friday (MTWThF), 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 (MWF) 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)
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.
Follow-Up Procedures and Evaluations:Follow-up visits will be conducted at month 1, month 3 and month 6 after the last treatment session and shall include:
Measuring IIEF-EF, GAQ, SEP, and EHS scores of patients at the clinic at every follow-up visit
Reporting and recording adverse events at every follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 720 shockwave therapy | Active comparator | Device: Low Intensity Linear Shockwave Device for the Treatment of Erectile Dysfunction.5 daily sessions of shockwave therapy 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). |
| 600 shockwave therapy | Active comparator | Device: Low Intensity Linear Shockwave Device for the Treatment of Erectile Dysfunction.Three sessions of shockwave therapy 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) 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
- 30 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The patient must be willing and able to provide informed consent.
- The patient is a male between >30 and <80 years of age.
- PDE5i responsive or non-responsive. If on PDE5i patient will discontinue medication for 4 weeks before IIEF.
- Stable sexual relationship for over 3 months prior to enrollment.
- A minimum of 2 sexual attempts per month for at least one month prior to enrollment.
Key exclusion criteria (15 listed)
- The patient is currently or has participated in another study within the past three months, that may interfere with the results or conclusions of this study.
- The patient is under judicial protection (prison or custody).
- The patient is an adult under guardianship.
- The patient refuses to sign the consent.
- History of radical prostatectomy or extensive pelvic surgery ever.
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 Dysfunction.Also: RENOVA-EDThis is a prospective, randomized, clinical study aimed to evaluate the safety and efficacy of the two treatment schedules on symptomatic erectile dysfunction patients. 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 shockwave therapy, 720 shockwave therapy |
Primary outcome
International Index of Erectile Function (IIEF-EF) Questionnaire
Time frame: 7 months
IIEF is a 15 item self-administered questionnaire assessing erectile dysfunction and treatment outcomes. Total IIEF score range from 5-25 with scores classifying erectile dysfunction (ED) as: severe (5-7); moderate (8-11); mild to moderate (12-16); mild (17-21) and no ED (22-25). The questionnaire will be assessed at baseline (before 1 month washout prior to treatment initiation), 1 month follow up (at 2 months), 3 month follow up (at 4 months) and 6 months follow up (at 7 months). Time Frame: 7 months
3 secondary outcomes
Erection Hardness Score (EHS)
Time frame: 7 months
Sexual Encounter Profile (SEP)
Time frame: 7 months
Global Assessment Question (GAQ)
Time frame: 7 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19084865Mulhall JP. Defining and reporting erectile function outcomes after radical prostatectomy: challenges and misconceptions. J Urol. 2009 Feb;181(2):462-71. doi: 10.1016/j.juro.2008.10.047. Epub 2008 Dec 13.
- Background: PubMed 9187685Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology. 1997 Jun;49(6):822-30. doi: 10.1016/s0090-4295(97)00238-0.
- Background: PubMed 22425129Vardi Y, Appel B, Kilchevsky A, Gruenwald I. Does low intensity extracorporeal shock wave therapy have a physiological effect on erectile function? Short-term results of a randomized, double-blind, sham controlled study. J Urol. 2012 May;187(5):1769-75. doi: 10.1016/j.juro.2011.12.117. Epub 2012 Mar 15.
- Background: PubMed 20451317Vardi Y, Appel B, Jacob G, Massarwi O, Gruenwald I. Can low-intensity extracorporeal shockwave therapy improve erectile function? A 6-month follow-up pilot study in patients with organic erectile dysfunction. Eur Urol. 2010 Aug;58(2):243-8. doi: 10.1016/j.eururo.2010.04.004. Epub 2010 May 6.
- Background: PubMed 18619622Wang CJ, Kuo YR, Wu RW, Liu RT, Hsu CS, Wang FS, Yang KD. Extracorporeal shockwave treatment for chronic diabetic foot ulcers. J Surg Res. 2009 Mar;152(1):96-103. doi: 10.1016/j.jss.2008.01.026. Epub 2008 Mar 7.
- Background: PubMed 7497669Rompe JD, Rumler F, Hopf C, Nafe B, Heine J. Extracorporal shock wave therapy for calcifying tendinitis of the shoulder. Clin Orthop Relat Res. 1995 Dec;(321):196-201.
- Background: PubMed 1615601Haupt G, Haupt A, Ekkernkamp A, Gerety B, Chvapil M. Influence of shock waves on fracture healing. Urology. 1992 Jun;39(6):529-32. doi: 10.1016/0090-4295(92)90009-l.
- Background: PubMed 20134096Kikuchi Y, Ito K, Ito Y, Shiroto T, Tsuburaya R, Aizawa K, Hao K, Fukumoto Y, Takahashi J, Takeda M, Nakayama M, Yasuda S, Kuriyama S, Tsuji I, Shimokawa H. Double-blind and placebo-controlled study of the effectiveness and safety of extracorporeal cardiac shock wave therapy for severe angina pectoris. Circ J. 2010 Mar;74(3):589-91. doi: 10.1253/circj.cj-09-1028. Epub 2010 Feb 4.
- Background: PubMed 10037356Melman A, Gingell JC. The epidemiology and pathophysiology of erectile dysfunction. J Urol. 1999 Jan;161(1):5-11.
- Background: PubMed 16174548Vlachopoulos C, Rokkas K, Ioakeimidis N, Aggeli C, Michaelides A, Roussakis G, Fassoulakis C, Askitis A, Stefanadis C. Prevalence of asymptomatic coronary artery disease in men with vasculogenic erectile dysfunction: a prospective angiographic study. Eur Urol. 2005 Dec;48(6):996-1002; discussion 1002-3. doi: 10.1016/j.eururo.2005.08.002. Epub 2005 Aug 24.
- Derived from this study: PubMed 30025713Katz JE, Molina ML, Clavijo R, Prakash NS, Ramasamy R. A Phase 2 Randomized Trial To Evaluate Different Dose Regimens of Low-intensity Extracorporeal Shockwave Therapy for Erectile Dysfunction: Clinical Trial Update. Eur Urol Focus. 2018 Apr;4(3):336-337. doi: 10.1016/j.euf.2018.07.011. Epub 2018 Jul 17.
- Individual participant dataSharing planned: No
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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.
Ranjith Ramasamy, MD principal investigator
University of Miami
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 Linear Shockwave Device for the Treatment of Erectile Dysfunction. in people with Vasculogenic Erectile Dysfunction, run by University of Miami 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 9 inclusion and 15 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: finished, as of the sponsor's last update on 11 Jun 2020. 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?
Yes. Results are posted in the registry (first posted 11 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
On the ClinicalTrials.gov record for NCT03067987, which also lists 11 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 Jun 2020.