Back to resultsLow Intensity Linear Shockwave Therapy for Erectile Dysfunction
Primary Purpose
Vasculogenic Erectile Dysfunction
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low Intensity Linear Shockwave Device for the treatment of Erectile Dysfunction
Sponsored by
About this trial
This is an interventional treatment trial for Vasculogenic Erectile Dysfunction
Eligibility Criteria
Inclusion Criteria:
- 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
- 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).
Exclusion Criteria:
- 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
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
720 Low Intensity shockwave therapy
600 Low Intensity shockwaves therapy
Arm Description
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)
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
SEP (Sexual Encounter Profile) 2 & 3 at follow-ups
Sexual activity improvement leading to optimal penetration at follow-ups. 2 Yes or No questions
GAQ (Global Assessment Questions) at follow-ups
2 Yes or No questions assessing improvement with treatment
EHS (Erection Hardness Score) at follow-ups
Scale rating hardness of erection from 0-4 with 4 being highest
Full Information
NCT ID
NCT03843086
First Posted
January 28, 2019
Last Updated
May 17, 2022
Sponsor
University of Virginia
Collaborators
DIREX SYSTEMS CORPORATION
1. Study Identification
Unique Protocol Identification Number
NCT03843086
Brief Title
Low Intensity Linear Shockwave Therapy for Erectile Dysfunction
Official Title
Safety and Efficacy of Low Intensity Shockwaves for the Treatment of Erectile Dysfunction - Comparison of Two Treatment Schedules
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Change in device and protocol
Study Start Date
June 2019 (Anticipated)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
March 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
DIREX SYSTEMS CORPORATION
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vasculogenic Erectile Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
720 Low Intensity shockwave therapy
Arm Type
Active Comparator
Arm Description
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)
Arm Title
600 Low Intensity shockwaves therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Low Intensity Linear Shockwave Device for the treatment of Erectile Dysfunction
Other Intervention Name(s)
MoreNova
Intervention Description
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)
Primary Outcome Measure Information:
Title
International Index of Erectile Function (IIEF-EF) Questionnaire
Description
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
Time Frame
7 months
Secondary Outcome Measure Information:
Title
SEP (Sexual Encounter Profile) 2 & 3 at follow-ups
Description
Sexual activity improvement leading to optimal penetration at follow-ups. 2 Yes or No questions
Time Frame
7 months
Title
GAQ (Global Assessment Questions) at follow-ups
Description
2 Yes or No questions assessing improvement with treatment
Time Frame
7 months
Title
EHS (Erection Hardness Score) at follow-ups
Description
Scale rating hardness of erection from 0-4 with 4 being highest
Time Frame
7 months
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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).
Exclusion Criteria:
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
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan P Smith, M.D.
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Low Intensity Linear Shockwave Therapy for Erectile Dysfunction
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