Erectile Dysfunction
Conditions
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of the shockwave therapy to treat Erectile Dysfunction.
Interventions
DEVICEShockwave therapy
Each therapy session, lasting about 20 minutes, will deliver 720 shockwave therapy applied to the penis and to the left and right crus (shaft near the base)
Each therapy session, lasting about 20 minutes, will deliver sham shockwave therapy applied to the penis and to the left and right crus (shaft near the base)
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* The patient must be able willing and able to provide informed consent. * The patient is a male between 30 and 70 years of age (inclusive). * The patient has erectile dysfunction (ED) based of IIEF scores. * The patient has been in a stable relationship for over 3 months prior to enrollment. * A minimum of 2 sexual attempts per month for at least one month prior to enrollment - as documented by International Index of Erectile Dysfunction (IIEF) * The patient is suffering from erectile dysfunction lasting for over 6 months and not more than 5 years as per history provided by patient. * IIEF-EF score between 16 and 25. * Testosterone level 300-1000 ng/dL within 1 month prior to enrollment. A1C level ≤ 7% within 1 month prior to enrollment
Exclusion criteria
* 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. * Evidence of venous leak. * Past radiation therapy of the pelvic region within 12 months prior to enrollment. * Recovering from any cancer within 12 months prior to enrollment. * Neurological disease such as Alzheimers or Parkinson's disease which affects erectile function at the discretion of the investigator. * Psychiatric diagnosis or medications such as antidepressants, anxiolytic, antipsychotic that 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. * A1C level \> 7% within 1 month prior to enrollment or history of Insulin dependent diabetes. * The patient is taking blood thinners and has an international normalized ratio \>3. * Received shockwave treatment at least 6 months before enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| International Index of Erectile Function (IIEF) Erectile Function Subdomain (EF) Scores. | Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12 | The IIEF-EF questionnaire has a total score ranging from 0 - 30 with the higher score indicating better erectile function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Responding 'Yes' to the Sexual Encounter Profile (SEP) Questionnaire | Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12 | The SEP consists of two questions: 1) Over the past 4 weeks, were you able to insert your penis into your partner's vagina? and 2) Over the past 4 weeks, did your erection last long enough for you to have successful intercourse? Reported will be the number of participants responding yes to the 2 questions. |
| Erection Hardness Score (EHS) | Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12 | EHS has a total score ranging from 0 - 4 with the higher score indicating a better erection hardness |
Countries
United States
Participant flow
Recruitment details
Unable to complete target enrollment due to COVID-19 pandemic restrictions.
Participants by arm
| Arm | Count |
|---|---|
| 720 Shockwave Therapy Group Participants in this group will receive a total of 5 daily sessions of shockwave therapy within a week. Each therapy session will consist of 720 shockwave therapy applied to the penis and to the left and right crus (shaft near the base)
Shockwave therapy: Each therapy session, lasting about 20 minutes, will deliver 720 shockwave therapy applied to the penis and to the left and right crus (shaft near the base) | 13 |
| Sham Shockwave Therapy Participants in this group will receive a total of 5 daily sessions of sham shockwave therapy within a week. Sham therapy will be applied to the penis and to the left and right crus (shaft near the base).
Sham shockwave therapy: Each therapy session, lasting about 20 minutes, will deliver sham shockwave therapy applied to the penis and to the left and right crus (shaft near the base) | 10 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Waiting Period | Enrollment was halted; participants were unable to attend study visits due to COVID-19 restrictions. | 4 | 6 |
| Weekly Therapy Sessions | Enrollment was halted; participants were unable to attend study visits due to COVID-19 restrictions. | 8 | 3 |
Baseline characteristics
| Characteristic | 720 Shockwave Therapy Group | Sham Shockwave Therapy | Total |
|---|---|---|---|
| Age, Continuous | 52.4 years STANDARD_DEVIATION 10.5 | 51.2 years STANDARD_DEVIATION 8.9 | 51.7 years STANDARD_DEVIATION 9.4 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 13 Participants | 10 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 10 |
| other Total, other adverse events | 0 / 13 | 0 / 10 |
| serious Total, serious adverse events | 0 / 13 | 0 / 10 |
Outcome results
Primary
International Index of Erectile Function (IIEF) Erectile Function Subdomain (EF) Scores.
The IIEF-EF questionnaire has a total score ranging from 0 - 30 with the higher score indicating better erectile function.
Time frame: Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12
Population: No statistical analyses have been performed or would be considered scientifically appropriate because actual enrollment fell well below target enrollment. Enrollment terminated early as a result of the COVID-19 pandemic.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 720 Shockwave Therapy Group | International Index of Erectile Function (IIEF) Erectile Function Subdomain (EF) Scores. | Baseline | 18.8 score on a scale | Standard Deviation 2.7 |
| 720 Shockwave Therapy Group | International Index of Erectile Function (IIEF) Erectile Function Subdomain (EF) Scores. | Month 1 | 18.4 score on a scale | Standard Deviation 7.1 |
| 720 Shockwave Therapy Group | International Index of Erectile Function (IIEF) Erectile Function Subdomain (EF) Scores. | Month 3 | 18 score on a scale | — |
| Sham Shockwave Therapy | International Index of Erectile Function (IIEF) Erectile Function Subdomain (EF) Scores. | Baseline | 19.1 score on a scale | Standard Deviation 3.6 |
| Sham Shockwave Therapy | International Index of Erectile Function (IIEF) Erectile Function Subdomain (EF) Scores. | Month 1 | 17 score on a scale | Standard Deviation 4.5 |
| Sham Shockwave Therapy | International Index of Erectile Function (IIEF) Erectile Function Subdomain (EF) Scores. | Month 3 | 26 score on a scale | — |
Secondary
Erection Hardness Score (EHS)
EHS has a total score ranging from 0 - 4 with the higher score indicating a better erection hardness
Time frame: Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12
Population: No statistical analyses have been performed or would be considered scientifically appropriate because actual enrollment fell well below target enrollment. Enrollment terminated early as a result of the COVID-19 pandemic.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 720 Shockwave Therapy Group | Erection Hardness Score (EHS) | Baseline | 2.9 score on a scale | Standard Deviation 0.3 |
| 720 Shockwave Therapy Group | Erection Hardness Score (EHS) | Month 1 | 3.4 score on a scale | Standard Deviation 0.5 |
| 720 Shockwave Therapy Group | Erection Hardness Score (EHS) | Month 3 | 3 score on a scale | — |
| Sham Shockwave Therapy | Erection Hardness Score (EHS) | Baseline | 2.8 score on a scale | Standard Deviation 0.6 |
| Sham Shockwave Therapy | Erection Hardness Score (EHS) | Month 1 | 3.1 score on a scale | Standard Deviation 0.4 |
| Sham Shockwave Therapy | Erection Hardness Score (EHS) | Month 3 | 4 score on a scale | — |
Secondary
Number of Participants Responding 'Yes' to the Sexual Encounter Profile (SEP) Questionnaire
The SEP consists of two questions: 1) Over the past 4 weeks, were you able to insert your penis into your partner's vagina? and 2) Over the past 4 weeks, did your erection last long enough for you to have successful intercourse? Reported will be the number of participants responding yes to the 2 questions.
Time frame: Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12
Population: No statistical analyses have been performed or would be considered scientifically appropriate because actual enrollment fell well below target enrollment. Enrollment terminated early as a result of the COVID-19 pandemic.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 720 Shockwave Therapy Group | Number of Participants Responding 'Yes' to the Sexual Encounter Profile (SEP) Questionnaire | Baseline | 7 participants |
| 720 Shockwave Therapy Group | Number of Participants Responding 'Yes' to the Sexual Encounter Profile (SEP) Questionnaire | Month 1 | 3 participants |
| 720 Shockwave Therapy Group | Number of Participants Responding 'Yes' to the Sexual Encounter Profile (SEP) Questionnaire | Month 3 | 1 participants |
| Sham Shockwave Therapy | Number of Participants Responding 'Yes' to the Sexual Encounter Profile (SEP) Questionnaire | Baseline | 2 participants |
| Sham Shockwave Therapy | Number of Participants Responding 'Yes' to the Sexual Encounter Profile (SEP) Questionnaire | Month 1 | 2 participants |
| Sham Shockwave Therapy | Number of Participants Responding 'Yes' to the Sexual Encounter Profile (SEP) Questionnaire | Month 3 | 0 participants |