Low-Intensity Shockwave Therapy to Treat Erectile Dysfunction and Preserve Erectile Function After Prostate Cancer Surgery

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05877144
• Other study ID #: iRISID-2022-0980
• Status: Recruiting
• Phase: N/A
• Start date: July 6, 2023
• Est. completion date: April 2025

Study information

• Verified date: October 2023
• Source: Thomas Jefferson University
• Contact: Paul Chung, MD
• Phone: 215-955-6961
• Email: paul.chung[@]jefferson.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 2025
• Est. primary completion date: October 12, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• • 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

Related Conditions & MeSH terms

• Erectile Dysfunction
• Prostatic Neoplasms
• Stage I Prostate Cancer AJCC v8
• Stage II Prostate Cancer AJCC v8
• Stage III Prostate Cancer AJCC v8

Intervention

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
• Sham Intervention
Receive sham LiSWT
• Duplex Ultrasound
Undergo DDUS

Other:
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in duplex doppler ultrasound measurement	Will be assessed by penile flow parameters. 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.	Baseline to 6 months post LiSWT initiation
Secondary	Erectile function	Will be assessed using the IIEF, EHS, Sexual Encounter Profile diary and the Patient Global Impression of Improvement survey scores. 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.	At 1 month following LiSWT initiation
Secondary	Erectile function	Will be assessed using the IIEF, EHS, Sexual Encounter Profile diary and the Patient Global Impression of Improvement survey scores. 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.	At 3 month following LiSWT initiation
Secondary	Erectile function	Will be assessed using the IIEF, EHS, Sexual Encounter Profile diary and the Patient Global Impression of Improvement survey scores. 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.	At 6 month following LiSWT initiation
Secondary	Erectile function	Will be assessed using the IIEF, EHS, Sexual Encounter Profile diary and the Patient Global Impression of Improvement survey scores. 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.	At 9 month following LiSWT initiation
Secondary	Erectile function	Will be assessed using the IIEF, EHS, Sexual Encounter Profile diary and the Patient Global Impression of Improvement survey scores. 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.	At 12 month following LiSWT initiation