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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Erectile Dysfunction, Localized Prostate Carcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8

Intervention / Treatment
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* Procedure: Nerve-Sparing Prostatectomy
* Other: Medical Device Usage and Evaluation
* Procedure: Duplex Ultrasound
* Other: Survey Administration
* Procedure: Nerve-Sparing Prostatectomy
* Procedure: Sham Intervention
* Procedure: Duplex Ultrasound
* Other: Survey Administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: No Data Available
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARM I (LiSWT)<br>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<br>* Undergo nerve-sparing prostatectomy per standard of care<br>* Other names: nerve-sparing surgery;Other: Medical Device Usage and Evaluation<br>* Receive LiSWT<br>Procedure: Duplex Ultrasound<br>* Undergo DDUS<br>* Other names: Duplex Doppler Ultrasound;Other: Survey Administration<br>* Ancillary studies<br>|
| Sham Comparator: ARM II (sham LiSWT)<br>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<br>* Undergo nerve-sparing prostatectomy per standard of care<br>* Other names: nerve-sparing surgery;Procedure: Sham Intervention<br>* Receive sham LiSWT<br>* Other names: Sham Comparator;Procedure: Duplex Ultrasound<br>* Undergo DDUS<br>* Other names: Duplex Doppler Ultrasound;Other: Survey Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |