An interventional study of Low-Intensity Extracorporeal Shockwave Therapy and Standard of Care in Erectile Dysfunction, sponsored by University of Manitoba. Not yet recruiting at 1 site in Canada. Open to male participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by University of Manitoba · Not applicable, Interventional, and Treatment
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.
701 studies on the registry are indexed under Erectile Dysfunction; 125 are open to participants now.
This study's planned enrollment of 80 is above the median of 70 across 551 interventional studies indexed under Erectile Dysfunction.
Browse Erectile Dysfunction studies →University of Manitoba is the lead sponsor of 555 studies on the registry; 89 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Participants will receive standard postoperative penile rehabilitation as prescribed by the treating physician, without LiESWT.
Other: Standard of Care
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
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
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
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). Scores range from 0 - 21 with 0 being no urinary incontinence and 21 being severe urinary incontinence. Scores will then 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
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
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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