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

South Valley University25 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Erectile Dysfunction

Interventions

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

Eligibility

Sex: MALEMin age: 18 Months

Medical Language ↔ Plain English

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, 1 month 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.

Locations (1)

South Valley University

Cairo, Egypt

Outcomes

Primary Outcomes

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

Time frame: 2 years

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).

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)

Time frame: 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.

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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