LiSWT for Nerve Sparing Radical Prostatectomy ED

NCT05877144 | Completed

• 2 other identifiers: iRISID-2022-0980JT 22705
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Patient reported sexual function

  Will be assessed using the International Index of Erectile Function (IIEF) The IIEF is a15-item questionnaire - each item scored from 0 to 5 - examines five main domains of male sexual function: erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction. Outcomes measured only at 6 months post randomization will be analyzed using analysis of covariance with adjustment for the baseline value.

  At 6 months post low intensity shockwave therapy (LiSWT) initiation

• Patient reported sexual function

  Will be assessed using the Erection Hardness Scale (EHS). The EHS is a single-item validated Likert scale. Mixed effect linear regression will be used to model post randomization repeated measurements of continuous outcomes. From the results of the model, will estimate the mean difference between groups at each time point along with a 95% confidence interval. Outcomes measured only at 6 months post randomization will be analyzed using analysis of covariance with adjustment for the baseline value.

  At 6 months post low intensity shockwave therapy (LiSWT) initiation

Secondary Outcomes (6)

• Change in duplex doppler ultrasound measurement

  Baseline to 6 months post LiSWT initiation

• Erectile function

  At 1 month following LiSWT initiation

• Erectile function

  At 3 month following LiSWT initiation

• Erectile function

  At 6 month following LiSWT initiation

• Erectile function

  At 9 month following LiSWT initiation

Study Arms (2)

ARM I (LiSWT)

EXPERIMENTAL

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.

Procedure: Nerve-Sparing Prostatectomy; Other: Medical Device Usage and Evaluation; Procedure: Duplex Ultrasound; Other: Survey Administration

ARM II (sham LiSWT)

SHAM COMPARATOR

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.

Procedure: Nerve-Sparing Prostatectomy; Procedure: Sham Intervention; Procedure: Duplex Ultrasound; Other: Survey Administration

Interventions

Nerve-Sparing Prostatectomy PROCEDURE

Undergo nerve-sparing prostatectomy per standard of care

Also known as: nerve-sparing radical prostatectomy, nerve-sparing surgery

ARM I (LiSWT)

Medical Device Usage and Evaluation OTHER

Receive LiSWT

ARM I (LiSWT)

Duplex Ultrasound PROCEDURE

Undergo DDUS

Also known as: DD, Duplex Doppler, Duplex Doppler Ultrasound

ARM I (LiSWT)

Survey Administration OTHER

Ancillary studies

ARM I (LiSWT)

Sham Intervention PROCEDURE

Receive sham LiSWT

Also known as: Sham Comparator

ARM II (sham LiSWT)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Subject does not speak or understand English
• Subject has been treated with acoustic wave previously
• Subject has had prior penile surgery
• Patients with pacemakers or implantable defibrillators
• Patients who are using devices which are sensitive to electromagnetic radiation
• Patients who are found to have metastatic disease and require radiation/hormone therapy before initiation of shockwave/sham treatments
• Subject has lesions or active infections on the penis or perineum
• Subject is unwilling to remove piercings from the genital region
• Subject has a history of substance abuse within 12 months prior, or consuming \> 14 alcoholic drinks per week
• Subject has received an investigational drug within 30 days prior to signing consent
• Subject has received platelet-rich plasma (PRP) within 3 months of signing consent
• Subject has received stem cell within 6 months of signing consent
• Subject has any condition or exhibits behavior that indicates to the principle investigator (PI) that the subject is unlikely to be compliant with study procedures and visits
• Cognitively/decisionally-impaired individuals

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Erectile Dysfunction; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No Data Available
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: No Data Available

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 26, 2023
• Study Start: July 6, 2023
• Primary Completion: January 30, 2025
• Study Completion: January 30, 2025
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)