Clinical Trial of Low Intensity Shockwaves Therapy for Erectile Dysfunction Post-Radical Prostatectomy

Study Overview
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Brief Summary
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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

Official Title
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Randomized Controlled Trial of Low Intensity Shockwaves Therapy for the Treatment of Post-Radical Prostatectomy Erectile Dysfunction. SHARP-ED TRIAL

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Device: Shockwave Therapy
* Other: SHAM shockwave therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be willing and able to provide informed consent. Be male Be ≥ 40 and ≤ 75 years of age (inclusive). Undergo radical prostatectomy for prostate cancer (nerve sparing or non-nerve sparing without neoadjuvant chemotherapy or radiation therapy.) Be at least six weeks post radical prostatectomy. Be in a stable sexual relationship for over 3 months prior to enrollment. Have testosterone level of 300-1000 ng/dL within 1 month prior to enrollment. Have an HbA1c level ≤ 7% within 3 months prior to enrollment. Have undetectable PSA value at the time of enrollment Exclusion Criteria: 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. Be under judicial protection (prison or custody). Be an adult under guardianship. Refuse to sign the informed consent. Have evidence of venous leak prior to surgery or use of PDE5i prior to surgery Have past radiation therapy of the pelvic region or hormonal therapy with androgen deprivation within 12 months prior to enrollment. Be recovering from any cancer within 12 months prior to enrollment (other than prostate cancer) Have Neurological disease such as Alzheimer's or Parkinson's disease which affects erectile function (at the discretion of the investigator). 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). Have an anatomical malformation of the penis, including Peyronie's disease. Have testosterone level <300 or >1000 ng/dL within 1 month prior to enrollment. Be using blood thinners with international normalized ratio (INR) to be > 3. Have received shockwave therapy for at least 6 months before enrollment. Have detectable PSA value after the radical prostatectomy. Require radiation therapy after radical prostatectomy. Require hormonal therapy after radical prostatectomy.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SWT group<br>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. | Device: Shockwave Therapy<br>* 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)<br>|
| Placebo Comparator: SHAM group<br>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. | Other: SHAM shockwave therapy<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. |