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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Provide signed and dated informed consent form

• Willing to comply with all study procedures and be available for the duration of the study

• Men aged 18-80 diagnosed with localized prostate cancer

• Score 12 or higher on the pre-operative International Index of Erectile Function (IIEF) assessment

• Undergo the nerve-sparing radical prostatectomy procedure

• Be taking PDE5i medication for the entirety of the study (normal course of care)

• Be in a sexual relationship with a partner for at least 3 months

• Be willing to attempt sexual activity during the screening period and before each follow-up visit

• Be willing to stop all erectile aids (e.g. prescription and non-prescription erectile medications not part of this study, penile injections, vacuum erection devices, constriction rings) during the screening and study period

Locations
United States
Pennsylvania
Sidney Kimmel Cancer Center at Thomas Jefferson University
RECRUITING
Philadelphia
Contact Information
Primary
Paul Chung, MD
paul.chung@jefferson.edu
215-955-6961
Time Frame
Start Date: 2023-07-06
Estimated Completion Date: 2025-10-12
Participants
Target number of participants: 30
Treatments
Experimental: ARM I (LiSWT)
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.
Sham_comparator: ARM II (sham LiSWT)
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.
Sponsors
Leads: Thomas Jefferson University

This content was sourced from clinicaltrials.gov