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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
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)
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)
Desai Sethi Urology Institute - University of Miami, Miller School of Medicine
Miami, Florida, United States
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.
Time frame: Baseline to 6 months and Baseline to 12 months.
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
Time frame: 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.
Time frame: 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.
Time frame: 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
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Time frame: 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.
Time frame: Baseline to 6 months and Baseline to 12 months.