Randomized Control Trail of Shockwave Therapy on Treating Erectile Dysfunction Following Nerve-sparing Radical Prostatectomy.

N/ANot Yet RecruitingNCT07819084

University of Manitoba80 enrolled

Overview

This study will investigate whether low-intensity extracorporeal shockwave therapy (LiESWT) can help men recover erectile function after nerve-sparing prostate cancer surgery. Erectile dysfunction is common after this surgery, and current rehabilitation treatments mainly help manage symptoms rather than directly promoting recovery of the affected penile tissues. LiESWT is a non-invasive treatment that uses low-intensity shockwaves and may help improve blood flow and tissue recovery. The study will include 80 men undergoing nerve-sparing radical prostatectomy. Participants will be randomly assigned to receive either standard penile rehabilitation alone or standard rehabilitation plus eight LiESWT treatments. Erectile function, urinary function, pain, and potential side effects will be assessed throughout the 36-week study period. The main goal is to determine whether adding LiESWT increases the number of men who recover normal erectile function 24 weeks after surgery. The findings may help improve penile rehabilitation and sexual health outcomes for men recovering from prostate cancer surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Erectile Dysfunction Following Radical Prostatectomy Erectile Dysfunction Post Nerve-Sparing Radical Prostatectomy

Interventions

Low-Intensity Extracorporeal Shockwave TherapyDEVICE

LiESWT will be administered using the SoftWave UroGold system (SoftWave TRT, Inc., USA). Participants randomized to the experimental arm will receive eight LiESWT sessions in two treatment blocks during postoperative weeks 3-4 and 10-11, with two sessions per week separated by 2-3 days. During each approximately 15-minute session, 3,000 shockwave impulses will be delivered at a frequency of 5 Hz and an energy flux density of 0.09 mJ/mm². Shockwaves will be applied to six penile treatment sites: the right and left crura and the right and left proximal and distal penile shaft. LiESWT will be administered in addition to standard postoperative penile rehabilitation.

Standard of CareOTHER

Participants will receive standard postoperative penile rehabilitation following NSRP, as prescribed by the treating physician. Standard rehabilitation may include phosphodiesterase type 5 inhibitors (PDE5i) and/or intracavernosal injections (ICI) at the discretion of the treating physician.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18-70 years * Scheduled to undergo nerve-sparing radical prostatectomy (NSRP), either open or robotic * Referred to Men's Health Clinic Manitoba (MHCM) for postoperative penile rehabilitation * Histologically confirmed localized prostate cancer with Gleason score \<8 * Baseline erectile function of IIEF-EF ≥17 without erectogenic aids * Baseline urinary function of ICIQ ≤5 * Sexually active prior to surgery Exclusion Criteria: * Untreated hypogonadism or serum total testosterone \<300 ng/dL * Anatomical abnormalities of the genital or pelvic region that may interfere with treatment delivery or outcome assessment * Poorly controlled diabetes mellitus, defined as HbA1c exceeding acceptable surgical thresholds within three months prior to surgery * Any medical, psychological, or social condition that, in the investigators' opinion, would interfere with study participation or adherence to the protocol

Outcomes

Primary Outcomes

Proportion of Participants Achieving Normal Erectile Function

The proportion of participants achieving normal erectile function will be compared between the LiESWT plus standard of care (experimental) group and the standard of care alone (control) group. Erectile function will be assessed using the 6-item International Index of Erectile Function-Erectile Function (IIEF-EF) domain. Scores range from 1 to 30, with higher scores indicating better erectile function. Normal erectile function is defined as an IIEF-EF score ≥26.

Time frame: 24 weeks following nerve-sparing radical prostatectomy

Secondary Outcomes

Change in IIEF-EF Score from Baseline

Change in erectile function as measured by the 6-item International Index of Erectile Function-Erectile Function (IIEF-EF) domain. Scores range from 1 to 30, with higher scores indicating better erectile function. Longitudinal changes in IIEF-EF scores will be compared between the LiESWT plus standard of care group and the standard of care alone group.

Time frame: 9, 12, 24, and 36 weeks following nerve-sparing radical prostatectomy

Change in Urinary Function

Urinary function will be assessed using the International Consultation on Incontinence Questionnaire (ICIQ) and compared between the LiESWT plus standard of care group and the standard of care alone group.

Time frame: 9, 12, 24, and 36 weeks following nerve-sparing radical prostatectomy

Pain Assessed Using the Numeric Rating Scale

Pain and discomfort will be assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst possible pain). The NRS will be used to assess acute discomfort associated with LiESWT treatment and average pain experienced during the previous seven days.

Time frame: 9, 12, 24, and 26 weeks post nerve-sparing radical prostatectomy

Incidence and Severity of Adverse Events

The incidence and severity of adverse events and complications will be documented throughout the study and compared between the LiESWT plus standard of care group and the standard of care alone group. Potential intervention-related events include pain, infection, hematoma, localized skin redness or irritation, bruising, swelling, and temporary sensitivity.

Time frame: Through 36 weeks following nerve-sparing radical prostatectomy