Clinical trial NCT06152146: Clinical Trial of Low Intensity Shockwaves Therapy for Erectile Dysfunction Post-Radical Prostatectomy
Official title: Randomized Controlled Trial of Low Intensity Shockwaves Therapy for the Treatment of Post-Radical Prostatectomy Erectile Dysfunction. SHARP-ED TRIAL
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Erectile Dysfunction
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2023-11-30
Enrollment: 0
Sex: MALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

1. Be willing and able to provide informed consent.
2. Be male
3. Be ≥ 40 and ≤ 75 years of age (inclusive).
4. Undergo radical prostatectomy for prostate cancer (nerve sparing or non-nerve sparing without neoadjuvant chemotherapy or radiation therapy.)
5. Be at least six weeks post radical prostatectomy.
6. Be in a stable sexual relationship for over 3 months prior to enrollment.
7. Have testosterone level of 300-1000 ng/dL within 1 month prior to enrollment.
8. Have an HbA1c level ≤ 7% within 3 months prior to enrollment.
9. Have undetectable PSA value at the time of enrollment

Exclusion Criteria:

1. Be currently participating in a clinical trial or have recently received an investigational therapy within the past 30 days that may interfere with the results of this study.
2. Be under judicial protection (prison or custody).
3. Be an adult under guardianship.
4. Refuse to sign the informed consent.
5. Have evidence of venous leak prior to surgery or use of PDE5i prior to surgery
6. Have past radiation therapy of the pelvic region or hormonal therapy with androgen deprivation within 12 months prior to enrollment.
7. Be recovering from any cancer within 12 months prior to enrollment (other than prostate cancer)
8. Have Neurological disease such as Alzheimer's or Parkinson's disease which affects erectile function (at the discretion of the investigator).
9. Have a Psychiatric diagnosis or medications such as antidepressants, anxiolytic, antipsychotic that affects erectile function or any other medications (at the discretion of the investigator).
10. Have an anatomical malformation of the penis, including Peyronie's disease.
11. Have testosterone level \<300 or \>1000 ng/dL within 1 month prior to enrollment.
12. Be using blood thinners with international normalized ratio (INR) to be \> 3.
13. Have received shockwave therapy for at least 6 months before enrollment.
14. Have detectable PSA value after the radical prostatectomy.
15. Require radiation therapy after radical prostatectomy.
16. Require hormonal therapy after radical prostatectomy.

Primary outcomes:
measure: Change in number of participants reporting on Penetrative Intercourse
timeFrame: Baseline to 6 months and Baseline to 12 months.
Secondary outcomes:
measure: Change in Penile blood flow (Penile Duplex Ultrasound) measured in centimeters per second (cm/sec)
timeFrame: Baseline to 12 months.
measure: Change in IIEF-EF Scores
timeFrame: Baseline to 6 months and Baseline to 12 months.
measure: Change in SEP- Sexual Encounter Profile: Questions 2 and 3
timeFrame: Baseline to 6 months and Baseline to 12 months.
measure: Change in GAQ- Global Assessment Questions
timeFrame: Baseline to 6 months and Baseline to 12 months.
measure: Change in EHS- Erection Hardness Score
timeFrame: Baseline to 6 months and Baseline to 12 months.
Other outcomes:
Locations:
city: Miami
country: United States
facility: Desai Sethi Urology Institute - University of Miami, Miller School of Medicine
state: Florida
Study officials:
affiliation: University of Miami
name: Ranjith Ramasamy, MD
role: PRINCIPAL_INVESTIGATOR
References: