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

Primary Purpose

Erectile Dysfunction, Localized Prostate Carcinoma, Stage I Prostate Cancer AJCC v8

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nerve-Sparing Prostatectomy
Medical Device Usage and Evaluation
Duplex Ultrasound
Survey Administration
Nerve-Sparing Prostatectomy
Sham Intervention
Duplex Ultrasound
Survey Administration
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Sidney Kimmel Cancer Center at Thomas Jefferson UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

ARM I (LiSWT)

ARM II (sham LiSWT)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
May 5, 2023
Last Updated
October 19, 2023
Sponsor
Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT05877144
Brief Title
Low-Intensity Shockwave Therapy to Treat Erectile Dysfunction and Preserve Erectile Function After Prostate Cancer Surgery
Official Title
Preservation of Erectile Function With Early Postoperative Application of Low Intensity Shockwave Therapy After Nerve Sparing Radical Prostatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 6, 2023 (Actual)
Primary Completion Date
October 12, 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction, Localized Prostate Carcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
No Data Available
Masking
None (Open Label)
Masking Description
No Data Available
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ARM I (LiSWT)
Arm Type
Experimental
Arm Description
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 Title
ARM II (sham LiSWT)
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Nerve-Sparing Prostatectomy
Other Intervention Name(s)
nerve-sparing radical prostatectomy, nerve-sparing surgery
Intervention Description
Undergo nerve-sparing prostatectomy per standard of care
Intervention Type
Other
Intervention Name(s)
Medical Device Usage and Evaluation
Intervention Description
Receive LiSWT
Intervention Type
Procedure
Intervention Name(s)
Duplex Ultrasound
Other Intervention Name(s)
DD, Duplex Doppler, Duplex Doppler Ultrasound
Intervention Description
Undergo DDUS
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
Nerve-Sparing Prostatectomy
Other Intervention Name(s)
nerve-sparing radical prostatectomy, nerve-sparing surgery
Intervention Description
Undergo nerve-sparing prostatectomy per standard of care
Intervention Type
Procedure
Intervention Name(s)
Sham Intervention
Other Intervention Name(s)
Sham Comparator
Intervention Description
Receive sham LiSWT
Intervention Type
Procedure
Intervention Name(s)
Duplex Ultrasound
Other Intervention Name(s)
DD, Duplex Doppler, Duplex Doppler Ultrasound
Intervention Description
Undergo DDUS
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Patient reported sexual function
Description
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.
Time Frame
At 6 months post low intensity shockwave therapy (LiSWT) initiation
Title
Patient reported sexual function
Description
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.
Time Frame
At 6 months post low intensity shockwave therapy (LiSWT) initiation
Secondary Outcome Measure Information:
Title
Change in duplex doppler ultrasound measurement
Description
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.
Time Frame
Baseline to 6 months post LiSWT initiation
Title
Erectile function
Description
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.
Time Frame
At 1 month following LiSWT initiation
Title
Erectile function
Description
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.
Time Frame
At 3 month following LiSWT initiation
Title
Erectile function
Description
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.
Time Frame
At 6 month following LiSWT initiation
Title
Erectile function
Description
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.
Time Frame
At 9 month following LiSWT initiation
Title
Erectile function
Description
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.
Time Frame
At 12 month following LiSWT initiation

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul Chung, MD
Phone
215-955-6961
Email
paul.chung@jefferson.edu
Facility Information:
Facility Name
Sidney Kimmel Cancer Center at Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Chung, MD
Phone
215-955-6961
Email
Paul.Chung@jefferson.edu

12. IPD Sharing Statement

Learn more about this trial

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

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