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| ID | Type | Description | Link |
|---|---|---|---|
| 20181840 | Other Identifier | western IRB |
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Due to COVID-19 Pandemic
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The purpose of this study is to evaluate the safety and effectiveness of the shockwave therapy to treat Erectile Dysfunction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 720 shockwave therapy Group | Active Comparator | 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) |
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| Sham shockwave therapy | Sham Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shockwave therapy | Device | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ranjith Ramasamy, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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Unable to complete target enrollment due to COVID-19 pandemic restrictions.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Visit |
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| Weekly Therapy Sessions |
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| Month 1 Visit |
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| Waiting Period |
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| Month 3 Visit |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12 |
|
3 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 | 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) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ranjith Ramasamy, MD | University of Miami, Miller School of Medicine - Desai Sethi Urology Institute | 305-243-4562 | ramasamy@miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 2, 2018 | Jun 20, 2023 | Prot_SAP_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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| ID | Term |
|---|---|
| D000074059 | Extracorporeal Shockwave Therapy |
| ID | Term |
|---|---|
| D014464 | Ultrasonic Therapy |
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
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| Sham shockwave therapy | Other | 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) |
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| Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12 |
| Erection Hardness Score (EHS) | EHS has a total score ranging from 0 - 4 with the higher score indicating a better erection hardness | Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12 |
| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 | 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) |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| OG001 | 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) |
|
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| 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. | 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. | Posted | Number | participants | Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12 |
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|
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| Secondary | Erection Hardness Score (EHS) | EHS has a total score ranging from 0 - 4 with the higher score indicating a better erection hardness | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12 |
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|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | 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) | 0 | 10 | 0 | 10 | 0 | 10 |
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| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D026741 |
| Physical Therapy Modalities |
| D012046 | Rehabilitation |
| Month 1 |
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| Month 3 |
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| Month 1 |
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| Month 3 |
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