Clinical trial NCT05877144: LiSWT for Nerve Sparing Radical Prostatectomy ED
Official title: Preservation of Erectile Function With Early Postoperative Application of Low Intensity Shockwave Therapy After Nerve Sparing Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Erectile Dysfunction
Localized Prostate Carcinoma
Stage I Prostate Cancer AJCC v8
Stage II Prostate Cancer AJCC v8
Stage III Prostate Cancer AJCC v8
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: No Data Available
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Patient reported sexual function
timeFrame: At 6 months post low intensity shockwave therapy (LiSWT) initiation
measure: Patient reported sexual function
timeFrame: At 6 months post low intensity shockwave therapy (LiSWT) initiation
Secondary outcomes:
measure: Change in duplex doppler ultrasound measurement
timeFrame: Baseline to 6 months post LiSWT initiation
measure: Erectile function
timeFrame: At 1 month following LiSWT initiation
measure: Erectile function
timeFrame: At 3 month following LiSWT initiation
measure: Erectile function
timeFrame: At 6 month following LiSWT initiation
measure: Erectile function
timeFrame: At 9 month following LiSWT initiation
measure: Erectile function
timeFrame: At 12 month following LiSWT initiation
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
Study officials:
References: