LiSWT for Nerve Sparing Radical Prostatectomy ED
NCT05877144 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2025-07-15
Summary
This phase I clinical trial studies how well low intensity shockwave therapy (LiSWT) improves erectile function in patients who have had nerve-sparing radical prostatectomy (NS-RP), a type of surgery that attempts to save the nerves near the tissues being removed, for prostate cancer. Erectile dysfunction (ED) is a known side effect of the radical prostatectomy procedure. The low intensity shockwave therapy delivers painless electrotherapy pulse to increase blood flow and supply, activation of tissues and wound healing. Using LiSWT after NS-PRP may improve erectile function in men with prostate cancer.
Conditions
- Erectile Dysfunction
- Localized Prostate Carcinoma
- Stage I Prostate Cancer AJCC v8
- Stage II Prostate Cancer AJCC v8
- Stage III Prostate Cancer AJCC v8
Interventions
- PROCEDURE
-
Nerve-Sparing Prostatectomy
Undergo nerve-sparing prostatectomy per standard of care
- OTHER
-
Medical Device Usage and Evaluation
Receive LiSWT
- PROCEDURE
-
Duplex Ultrasound
Undergo DDUS
- OTHER
-
Survey Administration
Ancillary studies
- PROCEDURE
-
Nerve-Sparing Prostatectomy
Undergo nerve-sparing prostatectomy per standard of care
- PROCEDURE
-
Sham Intervention
Receive sham LiSWT
- PROCEDURE
-
Duplex Ultrasound
Undergo DDUS
- OTHER
-
Survey Administration
Ancillary studies
Sponsors & Collaborators
-
Thomas Jefferson University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-07-06
- Primary Completion
- 2025-01-30
- Completion
- 2025-01-30
Countries
- United States
Study Locations
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