TerminatedNot Applicable

Low-intensity Shockwave Therapy for Post-radical Prostatectomy Erectile Dysfunction

Stopped: 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.

United States5 participantsStarted 2024-01-10

Plain-language summary

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.

Who can participate

Age range45 Years – 70 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Men age 45-70 who had robotic prostatectomy within 6 to 18 months
✓. Documented nerve sparing during radical prostatectomy procedure
✓. Mild to moderate ED after prostatectomy
✓. IIEF score \> 18 before surgery
✓. Testosterone level \> 300 mg/dl post-surgery
✓. Sexually active

Exclusion criteria

✕. Prior penile surgery
✕. Lesions or active infections on the penis or perineum
✕. Anatomical abnormalities in the genitalia or pelvic region
✕. Unwilling to remove piercing from genital region
✕. Post radical prostatectomy complications that could impact safety or effectiveness of ESWT (hematoma, unresolved anastomotic leak)
✕. Previous or scheduled treatment with pelvic radiotherapy and/or androgen deprivation therapy
✕. Anticoagulant medication (except acetylsalicylic acid up to 80 mg daily).
✕. Any other condition that would prevent the patient from completing the study, as judged by the PI

What they're measuring

To assess the effectiveness of LiSWT in participants with mild to moderate erectile dysfunction post-prostatectomy with the International Index of Erectile Function questionnaire.

Timeframe: 4 months

To assess the effectiveness of LiSWT in participants with mild to moderate erectile dysfunction post-prostatectomy with the Erectile Hardness Score questionnaire.

Timeframe: 4 months

Trial details

NCT IDNCT06219785

SponsorThe Methodist Hospital Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-01

View on ClinicalTrials.gov More Erectile Dysfunction Following Radical Prostatectomy trials

Who can participate

Age range45 Years – 70 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Men age 45-70 who had robotic prostatectomy within 6 to 18 months
✓. Documented nerve sparing during radical prostatectomy procedure
✓. Mild to moderate ED after prostatectomy
✓. IIEF score \> 18 before surgery
✓. Testosterone level \> 300 mg/dl post-surgery
✓. Sexually active

Exclusion criteria

✕. Prior penile surgery
✕. Lesions or active infections on the penis or perineum
✕. Anatomical abnormalities in the genitalia or pelvic region
✕. Unwilling to remove piercing from genital region
✕. Post radical prostatectomy complications that could impact safety or effectiveness of ESWT (hematoma, unresolved anastomotic leak)
✕. Previous or scheduled treatment with pelvic radiotherapy and/or androgen deprivation therapy
✕. Anticoagulant medication (except acetylsalicylic acid up to 80 mg daily).
✕. Any other condition that would prevent the patient from completing the study, as judged by the PI

What they're measuring

To assess the effectiveness of LiSWT in participants with mild to moderate erectile dysfunction post-prostatectomy with the International Index of Erectile Function questionnaire.

Timeframe: 4 months

To assess the effectiveness of LiSWT in participants with mild to moderate erectile dysfunction post-prostatectomy with the Erectile Hardness Score questionnaire.

Timeframe: 4 months