Low-intensity Shockwave Therapy for Post-radical Prostatectomy Erectile Dysfunction
NCT ID: NCT06219785
Last Updated: 2024-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
5 participants
INTERVENTIONAL
2024-01-10
2024-10-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Active
1. Patient lies down with legs extended.
2. In order to get a proper transmission, a drop of silicone oil is applied on the anatomical stand-off before putting the ring.
3. Connect the headpiece to the ring.
4. Apply ultrasound gel for proper energy transmission on the shaft of the penis
5. 1500 shocks to the lateral penile shaft (distal, mid, and proximal penile shaft), 500 impulses in each area, for a total of 1500 shocks along the penis
6. Duration of the procedure: approximately 30 minutes
Low-Intensity Shockwave therapy (LiSWT)
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.
Control
1. Patient lies down with legs extended.
2. In order to get a proper transmission, a drop of silicone oil is applied on the anatomical stand-off before putting the ring.
3. Connect the headpiece to the ring.
4. Apply ultrasound gel for proper energy transmission on the shaft of the penis
5. 1500 shocks to the lateral penile shaft (distal, mid, and proximal penile shaft), 500 impulses in each area, for a total of 1500 shocks along the penis
6. Duration of the procedure: approximately 30 minutes
Low-Intensity Shockwave therapy (LiSWT)
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.
Interventions
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Low-Intensity Shockwave therapy (LiSWT)
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.
Eligibility Criteria
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Inclusion Criteria
2. Documented nerve sparing during radical prostatectomy procedure
3. Mild to moderate ED after prostatectomy
4. IIEF score \> 18 before surgery
5. Testosterone level \> 300 mg/dl post-surgery
6. Sexually active
Exclusion Criteria
2. Lesions or active infections on the penis or perineum
3. Anatomical abnormalities in the genitalia or pelvic region
4. Unwilling to remove piercing from genital region
5. Post radical prostatectomy complications that could impact safety or effectiveness of ESWT (hematoma, unresolved anastomotic leak)
6. Previous or scheduled treatment with pelvic radiotherapy and/or androgen deprivation therapy
7. Anticoagulant medication (except acetylsalicylic acid up to 80 mg daily).
8. Any other condition that would prevent the patient from completing the study, as judged by the PI
45 Years
70 Years
MALE
No
Sponsors
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The Methodist Hospital Research Institute
OTHER
Responsible Party
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Brian Miles
Brian J Miles MD
Principal Investigators
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Brian J. Miles, MD
Role: PRINCIPAL_INVESTIGATOR
The Methodist Hospital Research Institute
Locations
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Houston Methodist
Houston, Texas, United States
Countries
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Other Identifiers
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Pro00037405
Identifier Type: -
Identifier Source: org_study_id
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