Shockwave Therapy on Treating Erectile Dysfunction Following Nerve-sparing Radical Prostatectomy.

NCT07819084 | Not Yet Recruiting DMC

• 1 other identifier: 5119
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Erectile Dysfunction

Keywords

Erectile Dysfunction; Nerve-Sparing Radical Prostatectomy; Low-Intensity Extracorporeal Shockwave Therapy; Radical Prostatectomy

Outcome Measures

Primary Outcomes (1)

• 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.

  24 weeks following nerve-sparing radical prostatectomy

Secondary Outcomes (4)

• Change in IIEF-EF Score from Baseline

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

• Change in Urinary Function

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

• Pain Assessed Using the Numeric Rating Scale

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

• Incidence and Severity of Adverse Events

  Through 36 weeks following nerve-sparing radical prostatectomy

Study Arms (2)

LiESWT + Standard of Care

EXPERIMENTAL

Participants will receive standard postoperative penile rehabilitation in combination with LiESWT. LiESWT will be administered in eight treatment sessions during postoperative weeks 3-4 and 10-11, with two sessions per week, 2-3 days apart. Each approximately 15-minute session will deliver 3,000 shockwave impulses at 5 Hz and an energy flux density of 0.09 mJ/mm² to six anatomical penile treatment sites. Standard penile rehabilitation will be prescribed at the discretion of the treating physician.

Device: Low-Intensity Extracorporeal Shockwave Therapy

Standard of Care

ACTIVE COMPARATOR

Participants will receive standard postoperative penile rehabilitation as prescribed by the treating physician, without LiESWT.

Other: Standard of Care

Interventions

Low-Intensity Extracorporeal Shockwave Therapy DEVICE

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.

Also known as: SoftWave UroGold

LiESWT + Standard of Care

Standard of Care OTHER

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.

Also known as: Phosphodiesterase type 5 inhibitors (PDE5i), Intracavernosal injections (ICI), Post-Operative Penile Rehabilitation

Standard of Care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead
• Motorcycle Ride for Dad: collaborator

Study Sites (1)

Men's Health Clinic Manitoba

Winnipeg, Manitoba, R3K 1M3, Canada

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Standard of Care; Phosphodiesterase 5 Inhibitors

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Phosphodiesterase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Dr. Premal Patel, MD

CONTACT

204-221-4476; ppatel5@hsc.mb.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 14, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): January 1, 2031
• Last Updated: September 30, 2026

Record last verified: 2026-09

Locations

CA (1)