Erectile DysfunctionREVIVENCT07819084
Shockwave Therapy on Treating Erectile Dysfunction Following Nerve-sparing Radical Prostatectomy.
A study testing Low-Intensity Extracorporeal Shockwave Therapy in people with Erectile Dysfunction, run by University of Manitoba at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Low-Intensity Extracorporeal Shockwave Therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2026to 1 Jan 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Men's Health Clinic Manitoba
Winnipeg, Manitoba, R3K 1M3
Dr. Premal Patel, MD, 204-221-4476, ppatel5@hsc.mb.ca
Premal Patel, MD
About this study
Official title: Penile Tissue Rehabilitation Post Nerve-sparing Radical Prostatectomy Using Low-intensity Extracorporeal Shockwave Therapy - A Randomized Control Trial
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
- Being tested
- Low-Intensity Extracorporeal Shockwave Therapy, Standard of Care
- Keywords
- Erectile Dysfunction, Nerve-Sparing Radical Prostatectomy, Low-Intensity Extracorporeal Shockwave Therapy, Radical Prostatectomy
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Intensity Extracorporeal Shockwave TherapyDevice
Also called SoftWave UroGold
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
Also called Phosphodiesterase type 5 inhibitors (PDE5i), Intracavernosal injections (ICI), Post-Operative Penile Rehabilitation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks following nerve-sparing radical prostatectomy
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through 36 weeks following nerve-sparing radical prostatectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Jul 2030 (estimated)
- Study completion1 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Motorcycle Ride for Dad
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07819084
- Sponsor's protocol ID
- 5119
- Acronym
- REVIVE
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Penile Tissue Rehabilitation Post Nerve-sparing Radical Prostatectomy Using Low-intensity Extracorporeal Shockwave Therapy - A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07819084
- Acronym / sponsor ID
- REVIVE / 5119
- Conditions
- Erectile Dysfunction
- Keywords
- Erectile Dysfunction, Nerve-Sparing Radical Prostatectomy, Low-Intensity Extracorporeal Shockwave Therapy, Radical Prostatectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Motorcycle Ride for Dad
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Jul 2030 (estimated)
- Study completion
- 1 Jan 2031 (estimated)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LiESWT + Standard of Care | Experimental | Device: Low-Intensity Extracorporeal Shockwave TherapyParticipants 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. |
| Standard of Care | Active comparator | Other: Standard of CareParticipants will receive standard postoperative penile rehabilitation as prescribed by the treating physician, without LiESWT. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Intensity Extracorporeal Shockwave TherapyAlso: SoftWave UroGoldLiESWT 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. | Device | LiESWT + Standard of Care |
| Standard of CareAlso: Phosphodiesterase type 5 inhibitors (PDE5i), Intracavernosal injections (ICI), Post-Operative Penile RehabilitationParticipants 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. | Other | Standard of Care |
Primary outcome
Proportion of Participants Achieving Normal Erectile Function
Time frame: 24 weeks following nerve-sparing radical prostatectomy
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.
4 secondary outcomes
Change in IIEF-EF Score from Baseline
Time frame: 9, 12, 24, and 36 weeks following nerve-sparing radical prostatectomy
Change in Urinary Function
Time frame: 9, 12, 24, and 36 weeks following nerve-sparing radical prostatectomy
Pain Assessed Using the Numeric Rating Scale
Time frame: 9, 12, 24, and 26 weeks post nerve-sparing radical prostatectomy
Incidence and Severity of Adverse Events
Time frame: Through 36 weeks following nerve-sparing radical prostatectomy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Intensity Extracorporeal Shockwave Therapy in people with Erectile Dysfunction, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Premal Patel, MD (204-221-4476, ppatel5@hsc.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Achieving Normal Erectile Function (time frame: 24 weeks following nerve-sparing radical prostatectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.