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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Effect of LISWT on EHS, IIEF score & penile doppler | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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). | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Valley University | Qina | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42334516 | Derived | 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. |
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|
| 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. | 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 | 2 years. |
| Change from Baseline in penile doppler parameter RI at 6 & 12 Months post Low-intensity shock wave therapy (LiSWT). |
| 2 years |
| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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