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

NCT07460167 | Completed DMC

• 1 other identifier: SVUMEDURO0162237692
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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 . 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

Outcome Measures

Primary Outcomes (1)

• 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

  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).

  2 years.

• Change from the baseline of Erectile Hardness Scale (EHS) at 6 & 12 Months post Low-intensity shock wave therapy (LiSWT).

  2 years.

• Change from Baseline in penile doppler parameter EDV at 6 & 12 Months post Low-intensity shock wave therapy (LiSWT).

  2 years.

• Change from Baseline in penile doppler parameter RI at 6 & 12 Months post Low-intensity shock wave therapy (LiSWT).

  2 years

Study Arms (1)

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

Interventions

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

Effect of LISWT on EHS, IIEF score & penile doppler

Eligibility Criteria

• Age: 18 Months+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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, 1 month post operative.
• Age 18-70 years.
• Patient is able and willing to sign informed consent \& complete all study requirements.

You may not qualify if:

• 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.

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

South Valley University

Cairo, Egypt

Location

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Mohammed Talaat, Assistant Lecturer of Urology, Faculty of Medicine, South Valley University, principle investigator, clinical assistant lecturer.

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: March 10, 2026
• Study Start: October 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: January 1, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

EG (1)