NCT05877144

LiSWT for Nerve Sparing Radical Prostatectomy ED

Preservation of Erectile Function With Early Postoperative Application of Low Intensity Shockwave Therapy After Nerve Sparing Radical Prostatectomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To determine whether LiSWT following nerve-sparing radical prostatectomy (NS-RP) improves outcomes in men with erectile dysfunction (ED) supported by cGMP phosphodiesterase inhibitor (PDE5i) medication. SECONDARY OBJECTIVES: I. To determine whether LiSWT improves duplex doppler ultrasound (DDUS) flow parameters at 6 months following LiSWT treatment. II. To determine the postoperative durability of any beneficial outcome of LiWST treatment to erectile function. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo nerve-sparing radical prostatectomy per standard of care. Patients then receive LiSWT treatment weekly for 6 weeks, then have a 6 week break, followed by 6 more weekly treatments. Patients also undergo DDUS at baseline and during follow up. ARM II: Patients undergo nerve-sparing radical prostatectomy per standard of care. Patients then receive sham LiSWT treatment weekly for 6 weeks, then have a 6 week break, followed by 6 more weekly treatments. Patients also undergo DDUS at baseline and during follow up.

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

Type	Name	Description
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

Timeline

• Start date: 2023-07-06
• Primary completion: 2025-01-30
• Completion: 2025-01-30
• First posted: 2023-05-26
• Last updated: 2025-07-15

Locations

1 site across 1 country: United States