Ignite Creation Date:
2024-05-06 @ 9:45 AM
Last Modification Date:
2024-10-26 @ 12:19 PM
Study NCT ID:
NCT03067987
Status:
COMPLETED
Last Update Posted:
2020-06-11
First Post:
2017-02-23
Brief Title:
Safety and Efficacy of Low Intensity Shockwave for the Treatment of Erectile Dysfunction
Sponsor:
University of Miami
Organization:
University of Miami
Study Overview
Official Title:
Safety and Efficacy of Low Intensity Shockwave for the Treatment of Erectile Dysfunction- Comparison of Two Treatment Schedule
Status:
COMPLETED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 ObjectivesTo 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
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 ObjectivesTo 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
RationaleLinear 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 al3 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 al4 showed that Low intensity shock waves treated group showed radiological signs of faster healing
Calcifying tendinitis Rompe et al5 showed that shock wave to patient suffering from calcifying tendinitis showed a 625 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 al6 showed that Extracorporeal Shock Wave Therapy ESWT to patients with diabetic foot ulcer showed complete improvement in 31 and partial improvement in 58MoreoverExtracorporeal 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 209 58 vs 135 41 p 0001 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 67 09 vs 30 14 p 00322 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 82 vs 01 ml per minute per dl p 00001
Primary Efficacy ObjectiveTo evaluate change of Erectile Function-Erectile Function score 9 from baseline to follow-ups 1 3 and 6 months post treatment
Secondary ObjectivesTo 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 Patients medical co-medication history will be collected and documented and a physical examination will be performed
Previous months 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 inclusionexclusion criteria patients will be recruited to the study and randomized into one of the two groups in a 11 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 physicians 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 EvaluationsFollow-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
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
RationaleLinear 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 al3 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 al4 showed that Low intensity shock waves treated group showed radiological signs of faster healing
Calcifying tendinitis Rompe et al5 showed that shock wave to patient suffering from calcifying tendinitis showed a 625 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 al6 showed that Extracorporeal Shock Wave Therapy ESWT to patients with diabetic foot ulcer showed complete improvement in 31 and partial improvement in 58MoreoverExtracorporeal 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 209 58 vs 135 41 p 0001 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 67 09 vs 30 14 p 00322 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 82 vs 01 ml per minute per dl p 00001
Primary Efficacy ObjectiveTo evaluate change of Erectile Function-Erectile Function score 9 from baseline to follow-ups 1 3 and 6 months post treatment
Secondary ObjectivesTo 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 Patients medical co-medication history will be collected and documented and a physical examination will be performed
Previous months 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 inclusionexclusion criteria patients will be recruited to the study and randomized into one of the two groups in a 11 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 physicians 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 EvaluationsFollow-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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None