Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
8 participants
INTERVENTIONAL
2023-07-06
2025-01-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Nerve-Sparing Prostatectomy
Undergo nerve-sparing prostatectomy per standard of care
Medical Device Usage and Evaluation
Receive LiSWT
Duplex Ultrasound
Undergo DDUS
Survey Administration
Ancillary studies
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.
Nerve-Sparing Prostatectomy
Undergo nerve-sparing prostatectomy per standard of care
Sham Intervention
Receive sham LiSWT
Duplex Ultrasound
Undergo DDUS
Survey Administration
Ancillary studies
Interventions
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Nerve-Sparing Prostatectomy
Undergo nerve-sparing prostatectomy per standard of care
Medical Device Usage and Evaluation
Receive LiSWT
Duplex Ultrasound
Undergo DDUS
Survey Administration
Ancillary studies
Nerve-Sparing Prostatectomy
Undergo nerve-sparing prostatectomy per standard of care
Sham Intervention
Receive sham LiSWT
Duplex Ultrasound
Undergo DDUS
Survey Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
80 Years
MALE
No
Sponsors
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Thomas Jefferson University
OTHER
Responsible Party
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Locations
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Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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JT 22705
Identifier Type: OTHER
Identifier Source: secondary_id
iRISID-2022-0980
Identifier Type: -
Identifier Source: org_study_id
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