Penile Rehabilitation in Patients With Erectile Dysfunction After Pelvic Fracture Urethral Injury Using Low-intensity Shock Wave.

June 8, 2026 updated by: Mohammed Talaat, South Valley University

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 .

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Qina, Egypt
        • South Valley University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Effect of LISWT on EHS, IIEF score & penile doppler
Device: ELvation® Piezowave² linear focused piezoelectric shock wave device (Richard Wolf, Vernon Hills, IL, USA) effect of itsshockwaves on Erectile dysfunction
ELvation® Piezowave² linear focused piezoelectric shock wave device (Richard Wolf, Vernon Hills, IL, USA) giving shckwaves

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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)
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.

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.
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.

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
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
  • The Resistive Index (RI) will be calculated to reflect restored veno-occlusive function.
  • Units of measure: Ratio
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
South Valley University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SVUMEDURO0162237692

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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