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Since the study opened for enrollment on June 6, 2023, we have enrolled only 5 participants, despite our goal of 100 participants over an 18-month period.
Several factors have contributed to this decision.
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This research study is trying to determine if Low-Intensity shock wave therapy (LiSWT) is safe and effective in patients with symptoms of erectile dysfunction (ED) after radical prostatectomy.
Participants will be randomized to the active treatment group or the control/placebo group.
All patients on active treatment will receive Low-Intensity shock wave treatment. Participants assigned to the control group will receive the treatment using a sham applicator. The placebo group will receive the same treatment as the active group, but the transducer used for shock wave treatment will be capped, meaning that no shock waves will be transmitted to the penis.
Participants on active shock wave treatment will receive once a week Low-Intensity shock wave treatments of 0.2 mJ/ mm² over the lateral penile shaft (distal, mid, and proximal penile shaft), 500 impulses in each area, for a total of 1500 shocks along the penis once a week for six weeks, with a total of 6 treatments once a week.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Active Comparator |
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| Control | Sham Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-Intensity Shockwave therapy (LiSWT) | Device | Participants will receive once-a-week LiSWT treatments of 0.2 mJ/ mm² over the lateral penile shaft (distal, mid, and proximal penile shaft), 500 impulses in each area, for a total of 1500 shocks along the penis once a week for six weeks, with a total of 6 treatments once a week. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effectiveness of LiSWT in participants with mild to moderate erectile dysfunction post-prostatectomy with the International Index of Erectile Function questionnaire. | The International Index of Erectile Function is a multidimensional scale that can be used to evaluate ED. It addresses the most relevant aspects of male sexual function. It involves five questions with a scale report from 0 to 5, 5 being the best value. | 4 months |
| To assess the effectiveness of LiSWT in participants with mild to moderate erectile dysfunction post-prostatectomy with the Erectile Hardness Score questionnaire. | The Erection Hardness Score is a self-reported tool that measures the hardness of an erection. It involves a scale report from 0 to 4, 4 being the best quality of erection. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| To determine whether LiSWT improves the Peak systolic velocity in the Duplex Doppler Ultrasound. | A hemodynamic parameter commonly used in Duplex Doppler Ultrasound is Peak systolic velocity. A value of 30 cm/s or greater indicates arterial competence. The higher the parameters, the better the response to the therapy. | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian J. Miles, MD | The Methodist Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Methodist | Houston | Texas | 77030 | United States |
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Following completion of the 3-month follow-up visit, subjects will be unblinded. Subjects who received the Placebo/control treatment will be offered treatment using the active device applicator.
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| To determine whether LiSWT improves the Resistive index in the Duplex Doppler Ultrasound. |
The second hemodynamic parameter commonly used in Duplex Doppler Ultrasound is the Resistive Index. A value greater than 0.90% would indicate a state of normality. The higher the parameters, the better the response to the therapy. |
| 4 months |