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NCT Number: NCT07460167

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

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 .

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Key information

Conditions

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

Age range

18 month and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

South Valley University

Qina, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ELvation® Piezowave² linear focused piezoelectric shock wave device (Richard Wolf, Vernon Hills, IL, USA) effect of itsshockwaves on Erectile dysfunction

Device

ELvation® Piezowave² linear focused piezoelectric shock wave device (Richard Wolf, Vernon Hills, IL, USA) giving shckwaves

Primary outcomes

  1. 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

Secondary outcomes

  1. 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. 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.

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

South Valley University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Mar 10, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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