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Study submission was discarded with the IRB and no longer moving forward
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Research study designed to learn about and compare Shockwave therapy (SWT) vs placebo (no shockwaves) treatment in men with moderate to severe erectile dysfunction (ED) after Radical Prostatectomy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SWT group | Active Comparator | Participants randomized to the treatment group will receive nine (9) shockwave sessions in total: one (1) shockwave session once per week for four (4) weeks, followed by one (1) shockwave session once per month (30±7 days) for the next five (5) months. 1,440 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura) for a total of 12,960 shocks. Participants will be in this group for up to 6 months. |
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| SHAM group | Placebo Comparator | Participants randomized to the sham (control) group will have nine (9) sham therapy sessions in total: one (1) sham session once per week for four (4) weeks, followed by one (1) sham session once per month (30±7 days) for the next five (5) months. The shockwave machine will be set to deliver 1,440 shock treatments, but a barrier will be placed around the shockwave probe to ensure that no shockwaves are delivered. Participants will be in this group for up to 6 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shockwave Therapy | Device | Each therapy session will last about 20 minutes, during which 1,440 shockwaves will be applied to the penis via the left and right crus (shaft near the base) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in number of participants reporting on Penetrative Intercourse | Number of participants reporting the ability to have penetrative intercourse with or without PDE5i but without the use of intracavernosal injections was chosen as the primary clinical efficacy assessment tool in this study. | Baseline to 6 months and Baseline to 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Penile blood flow (Penile Duplex Ultrasound) measured in centimeters per second (cm/sec) | Penile Blood Flow will be reported as Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV), both assessed in cm/sec, via Penile Doppler ultrasonography | Baseline to 12 months. |
| Change in IIEF-EF Scores |
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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 |
|---|---|---|---|---|---|---|
| Desai Sethi Urology Institute - University of Miami, Miller School of Medicine | Miami | Florida | 33136 | United States |
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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 1440 SHAM shockwave therapy applied to the penis via the left and right crus (shaft near the base) |
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The International Index of Erectile Function - Erectile Function ( domain score is a patient questionnaire (six questions) used to measure various aspects of erectile performance and assess disease severity in efficacy trials concerning ED. The International Index of Erectile Function - Erectile Function has a minimum score of 0 and max of 30, higher scores mean a better outcome. |
| Baseline to 6 months and Baseline to 12 months. |
| Change in SEP- Sexual Encounter Profile: Questions 2 and 3 | The Sexual Encounter Profile (SEP) is a log diary completed after each sexual attempt, providing information as to whether the erection was hard enough to penetrate (SEP 2), or whether it was maintained for completion (SEP 3). Mixed effect linear regression will be used to model post randomization repeated measurements of continuous outcomes. From the results of the model, the mean difference between groups at each time point will be estimated along with a 95% confidence interval. | Baseline to 6 months and Baseline to 12 months. |
| Change in GAQ- Global Assessment Questions | The Global Assessment Questions is a measure of perceived improvements in erectile function and sexual ability. It also evaluate improvements in erectile function and ability to engage in sexual activity. The Scoring: GAQ is comprised of two 'yes or no' questions with a total score ranging from 0-2. Categorical data can be obtained from this measure | Baseline to 6 months and Baseline to 12 months. |
| Change in EHS- Erection Hardness Score | The Erection Hardness Score (EHS) is a single-item, patient-reported outcome (PRO) for scoring erection hardness. The EHS consists of a single question and the responses are scored from 0-4 with higher scored indicating more erection hardness. | Baseline to 6 months and Baseline to 12 months. |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D026741 |
| Physical Therapy Modalities |
| D012046 | Rehabilitation |