Erectile DysfunctionNCT07460167
Penile Rehabilitation in Patients With Erectile Dysfunction After Pelvic Fracture Urethral Injury Using Low-intensity Shock Wave.
A study testing ELvation® Piezowave² linear focused piezoelectric shock wave device (Richard Wolf, Vernon Hills, IL, USA) effect of itsshockwaves on Erectile dysfunction in people with Erectile Dysfunction, run by South Valley University at 1 site in Egypt.
Trial summary
the efficacy and safety of low intensity shock wave therapy (LiSWT) as an ED treatment. Olsen et al. demonstrated that LiSWT might be a possible solution in some ED patients of organic origin . Read more about this study
- Who is it for?
- Ages 18 months and older, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- ELvation® Piezowave² linear focused piezoelectric shock wave device (Richard Wolf, Vernon Hills, IL, USA) effect of itsshockwaves on Erectile dysfunction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 months and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient with erectile dysfunction post pelvic fracture associated with urethral injury as estimated via urethrography or endoscopy, managed by urethroplasty and proceed for LiSWT sessions, 3 months post operative.
- Age 18-70 years.
- Patient is able and willing to sign informed consent \& complete all study requirements.
Who cannot join
- Previous hypospadias surgery.
- Previous surgery for congenital curvature or Peyronie's disease.
- Previous pelvic irradiation therapy.
- Known grave psychiatric disorder.
- Haemophilia or any other clotting disorder that causes bleeding diathesis.
- Use of medication to increase erectile function, such as phosphodiesterase type 5 inhibitors and intracavernous injections, during the study.
- Other causes of erectile dysfunction either physical causes as diabetes mellitus, hypertension, cardiovascular disease \& emotional causes.
- Any condition or situation that, in the investigator's opinion, puts the patient at significant risk, could confound the study results, or could interfere significantly with the patient's participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Penile Rehabilitation in Patients With Erectile Dysfunction After Pelvic Fracture Urethral Injury Using Low-intensity Shock Wave: A Pilot Study.
the efficacy and safety of low intensity shock wave therapy (LiSWT) as an ED treatment. Olsen et al. demonstrated that LiSWT might be a possible solution in some ED patients of organic origin . The clinical results revealed that LiSWT was beneficial to ED patients nonresponsive to phosphodiesterase type 5 inhibitors (PDE5i) Animal studies revealed that LiSWT significantly improved ischemic muscle hemodynamics and might restore pathological changes in rats .
- Conditions
- Erectile Dysfunction
- Being tested
- ELvation® Piezowave² linear focused piezoelectric shock wave device (Richard Wolf, Vernon Hills, IL, USA) effect of itsshockwaves on Erectile dysfunction
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELvation® Piezowave² linear focused piezoelectric shock wave device (Richard Wolf, Vernon Hills, IL, USA) effect of itsshockwaves on Erectile dysfunctionDevice
ELvation® Piezowave² linear focused piezoelectric shock wave device (Richard Wolf, Vernon Hills, IL, USA) giving shckwaves
| Study group | Role | What they receive |
|---|---|---|
| Effect of LISWT on EHS, IIEF score & penile doppler | Other | Not described Receives: Device: ELvation® Piezowave² linear focused piezoelectric shock wave device (Richard Wolf, Vernon Hills, IL, USA) effect of itsshockwaves on Erectile dysfunction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in penile doppler parameter PSV at 6 & 12 Months post Low-intensity shock wave therapy (LiSWT).
Peak Systolic Velocity (PSV) will be measured via penile Doppler to evaluate arterial inflow. Hemodynamic recovery is indicated by increased PSV.
Unit of Measure: cm/s
Measured: 2 years
Secondary outcomes (4)
Change from the baseline of International Index of Erectile Function (IIEF) Score at 6 & 12 Months post Low-intensity shock wave therapy (LiSWT).
Unit of Measure: Units on a Scale (Total score from 1 to 25). Description: This validated 5-item questionnaire assesses erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. In this study, treatment success was defined as the restoration of erectile function to the normal IIEF-5 range (above 21)
Measured: 2 years.
Change from the baseline of Erectile Hardness Scale (EHS) at 6 & 12 Months post Low-intensity shock wave therapy (LiSWT).
Unit of Measure: Units on a Scale (Scoring system from 0 to 4). Description: A self-reported scale used to evaluate penile rigidity. The scores range from 0 (no enlargement) to 4 (full hardness and complete rigidity).It is a unique assessment of physical rigidity rather than broad sexual function.
It increased in the study showing significantly harder erections.
Measured: 2 years.
Change from Baseline in penile doppler parameter EDV at 6 & 12 Months post Low-intensity shock wave therapy (LiSWT).
End-Diastolic Velocity (EDV) will be measured via penile Doppler to evaluate venous leakage. Hemodynamic recovery is marked by a decrease in EDV.
Unit of Measure: cm/s
Measured: 2 years.
Change from Baseline in penile doppler parameter RI at 6 & 12 Months post Low-intensity shock wave therapy (LiSWT).
- The Resistive Index (RI) will be calculated to reflect restored veno-occlusive function.
- Units of measure: Ratio
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start1 Jul 2023
- Primary completion1 Oct 2024
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Talaat, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07460167
- Sponsor's protocol ID
- SVUMEDURO0162237692
- Status last verified
- Mar 2026
- First submitted
- 19 Feb 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fathi A, Alsagheer G, Talaat M, AbdelRazek M. Low-intensity shock wave therapy for penile rehabilitation in patients with erectile dysfunction following pelvic fracture urethral injury: a pilot study. Int Urol Nephrol. 2026 Jun 23. doi: 10.1007/s11255-026-05246-6. Online ahead of print.
PubMed 42334516
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Penile Rehabilitation in Patients With Erectile Dysfunction After Pelvic Fracture Urethral Injury Using Low-intensity Shock Wave: A Pilot Study.
- ClinicalTrials.gov ID
- NCT07460167
- Acronym / sponsor ID
- SVUMEDURO0162237692
- Conditions
- Erectile Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 10 Mar 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.
the efficacy and safety of low intensity shock wave therapy (LiSWT) as an ED treatment. Olsen et al. demonstrated that LiSWT might be a possible solution in some ED patients of organic origin . The clinical results revealed that LiSWT was beneficial to ED patients nonresponsive to phosphodiesterase type 5 inhibitors (PDE5i) Animal studies revealed that LiSWT significantly improved ischemic muscle hemodynamics and might restore pathological changes in rats .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Effect of LISWT on EHS, IIEF score & penile doppler | Other | Device: ELvation® Piezowave² linear focused piezoelectric shock wave device (Richard Wolf, Vernon Hills, IL, USA) effect of itsshockwaves on Erectile dysfunction |
Who may qualify
- Ages
- 18 months and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with erectile dysfunction post pelvic fracture associated with urethral injury as estimated via urethrography or endoscopy, managed by urethroplasty and proceed for LiSWT sessions, 3 months post operative.
- Age 18-70 years.
- Patient is able and willing to sign informed consent \& complete all study requirements.
Key exclusion criteria (8 listed)
- Previous hypospadias surgery.
- Previous surgery for congenital curvature or Peyronie's disease.
- Previous pelvic irradiation therapy.
- Known grave psychiatric disorder.
- Haemophilia or any other clotting disorder that causes bleeding diathesis.
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 |
|---|---|---|
| ELvation® Piezowave² linear focused piezoelectric shock wave device (Richard Wolf, Vernon Hills, IL, USA) effect of itsshockwaves on Erectile dysfunctionELvation® Piezowave² linear focused piezoelectric shock wave device (Richard Wolf, Vernon Hills, IL, USA) giving shckwaves | Device | Effect of LISWT on EHS, IIEF score & penile doppler |
Primary outcome
Change from Baseline in penile doppler parameter PSV at 6 & 12 Months post Low-intensity shock wave therapy (LiSWT).
Time frame: 2 years
Peak Systolic Velocity (PSV) will be measured via penile Doppler to evaluate arterial inflow. Hemodynamic recovery is indicated by increased PSV. Unit of Measure: cm/s
4 secondary outcomes
Change from the baseline of International Index of Erectile Function (IIEF) Score at 6 & 12 Months post Low-intensity shock wave therapy (LiSWT).
Time frame: 2 years.
Change from the baseline of Erectile Hardness Scale (EHS) at 6 & 12 Months post Low-intensity shock wave therapy (LiSWT).
Time frame: 2 years.
Change from Baseline in penile doppler parameter EDV at 6 & 12 Months post Low-intensity shock wave therapy (LiSWT).
Time frame: 2 years.
Change from Baseline in penile doppler parameter RI at 6 & 12 Months post Low-intensity shock wave therapy (LiSWT).
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Derived from this study: PubMed 42334516Fathi A, Alsagheer G, Talaat M, AbdelRazek M. Low-intensity shock wave therapy for penile rehabilitation in patients with erectile dysfunction following pelvic fracture urethral injury: a pilot study. Int Urol Nephrol. 2026 Jun 23. doi: 10.1007/s11255-026-05246-6. Online ahead of print.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ELvation® Piezowave² linear focused piezoelectric shock wave device (Richard Wolf, Vernon Hills, IL, USA) effect of itsshockwaves on Erectile dysfunction in people with Erectile Dysfunction, run by South Valley University at 1 site in Egypt.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 10 Jun 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in penile doppler parameter PSV at 6 & 12 Months post Low-intensity shock wave therapy (LiSWT). (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07460167, which also lists 1 linked publication.
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 10 Jun 2026.