N/A
Completed N=6
Low Intensity Shock Wave Therapy in the Management of Erectile Dysfunction
Source: ClinicalTrials.gov NCT04136288 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcomePrimary: Change in Right Resistive Index — 75.67 cm/second
Summary
Researchers are evaluating the efficacy of low intensity shockwave therapy (LISWT) via MoreNova in the treatment of erectile dysfunction (ED).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Right Resistive Index |
75.67 | — |
| PRIMARY Change in Right Peak Systolic Velocity |
16.27 | — |
| PRIMARY Change in Right Diastolic Velocity |
13.42 | — |
| PRIMARY Erection Hardness Score (EHS) |
0; 1; 1; 4; 0 | — |
| PRIMARY International Index of Erectile Function (IIEF - EF) Questionnaire |
1; 1; 1; 1; 2; 0 | — |
| PRIMARY Sexual Encounter Profile (SEP) Questionnaire |
3; 3; 2; 4 | — |
| PRIMARY Global Assessment Questionnaire |
1; 5; 0; 0; 4; 2 | — |
| PRIMARY Change in Left Peak Systolic Velocity |
26.63 | — |
| PRIMARY Change in Left Diastolic Velocity |
14.72 | — |
| PRIMARY Left Resistive Index |
73.5 | — |
Eligibility Criteria
Inclusion Criteria
- The patient must have given his informed and signed written consent
- The patient is a male
- Between 40 to and including 55 years of age
- The patient has ED for longer than 1 year but less than 5 years.
- The patient is PDE5i responsive, meaning he is able to achieve and maintain an erection under the effect of the maximal dosage of PDE5i
- IIEF-EF Domain score of 17-20
- Evidence Based Criteria: Doppler Clinical Exam
Exclusion Criteria
- The patient is participating in another study that may interfere with the results or conclusions of this study
- History of radical prostatectomy or extensive pelvic surgery
- Past radiation therapy of the pelvic region within 12 months prior to enrollment
- Recovering from cancer within 12 months prior to enrollment
- Neurological disease which effects erectile function
- Psychiatric disease which effects erectile function
- The patient is taking blood thinners
- History of Diabetes Mellitus
- History of Coronary Artery Disease
- Evidence Based Criteria: Doppler Clinical Exam
- Severe erectile dysfunction with IIEF-EF domain score < 16
Data sourced from ClinicalTrials.gov (NCT04136288). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.