6 vs 12 Sessions in Low Intensity Extracorporeal Shock Wave Treatment (LI-ESWT) for Erectile Dysfunction (ED)
Study Details
Study Description
Brief Summary
The present study aims to identify and compare the efficacy and safety of two different session frequency protocols (once vs twice per week) of low intensity extracorporeal shockwave treatment (LI-ESWT) using Aries ED device, in men with mild-moderate and severe vasculogenic ED, who have previously responded to oral PDE5-Is
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This is a randomized, 2 parallel arms, clinical trial. All patients will be PDE5I users/responders. After 1 month wash-out period, ED patients will be screened, in order to randomized 42 men with vasculogenic ED who had International Index of Erectile Function ED (IIEF-ED) domain scores between 6-25 and abnormal penile triplex-based hemodynamic parameters (peak flow velocity <35cm/sec). Then the 42 pts will be randomized to receive either one or two shockwave treatment sessions per week, without treatment interval. Every week all subjects may have at least one attempt for intercourse. All patients will complete 6 weeks of treatment.
Study visits and duration
Visit 1 (day 0): the basic work-up will take place, including medical and sexual history, as well as necessary lab tests, if needed. One month wash-out period will follow. During this period, all subjects will be asked to avoid any drug related to ED (PDE5i) and have at least 2-4 attempts for intercourse. Furthermore, patients will undergo triplex ultrasonography, unless they have already done so in the last 6 months. all patients will complete the IIEF-ED domain and will be randomized (1:1) to one of the two parallel study groups, using an online program. Groups A will receive treatment once per week for 6 weeks (6 sessions totally), and Groups B will receive treatment two times per week for 6 weeks (12 sessions totally). PDE5i use is prohibited throughout the study.
Treatment Visits: Patients will receive LI-ESWT , according to the study protocol.Interval between 2 treatments will be 7+2days for Group A and 3+1 day for Group B.At visit 6 and 12 a penile ultrasonography will be conducted in order to check for potential adverse events related to the treatment.
Follow-up visits 1 - 3 (4, 12 and 24 weeks post treatment): Patients will complete the IIEF-ED questionnaire and return the completed SEP diaries for the last 4 weeks prior to every visit. Visit data will also be recorded (protocol compliance, adverse events). At Week 12, triplex will be performed by the standard protocol. For Week 4 there is a + 3 days visit window, whereas for Weeks 12 and 24 there is a + 2 weeks visit window.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Group A Patients will receive one session of low intensity extracorporeal shock wave treatment (LI-ESWT) per week for 6 weeks (6 sessions totally). |
Device: Dornier Aries- ED device
The Dornier Aries-ED device will be used for the purpose of the study. LI-ESWT will be applied to the penile shaft 3 areas, and the 2 crura (two sites).
|
| Active Comparator: Group B Patients will receive two sessions of low intensity extracorporeal wave treatment (LI-ESWT) per week for 6 weeks (12 sessions totally). |
Device: Dornier Aries- ED device
The Dornier Aries-ED device will be used for the purpose of the study. LI-ESWT will be applied to the penile shaft 3 areas, and the 2 crura (two sites).
|
Outcome Measures
Primary Outcome Measures
- The percent of subjects who achieve clinically important difference (MCID) in the EF domain score of the IIEF [at 6 month follow up visit]
MCID is defined according to baseline ED severity as: Improvement by 2 or more in the EF domain score of the IIEF for patients with mild ED ( EF scores 17-25) at baseline. Improvement by 5 or more in the EF domain score of the IIEF for patients with moderate ED(EF scores 11-16) at baseline Improvement by 7 or more in the EF domain score of the IIEF for patients with severe ED (EF scores 0-10) at baseline
Secondary Outcome Measures
- Change in the EF domain score of the IIEF [baseline and 6 month follow up visit.]
EF domain of the IIEF questionnaire will be completed
- Change in Sexual Encounter Profile Question 3 (SEP3) score [baseline and 6 month follow up visit.]
The percent of subjects who answer ''YES'' in question 3 of SEP questionnaire will be reported
- Change in mean peak systolic velocity (PSV) [baseline and 3 month follow up visit]
Mean peak systolic velocity will be measured by penile triplex ultrasonography by the same investigator.
- Number of patients with treatment related adverse events [30 weeks]
Potential treatment related adverse events after the first LI-ESWT session and during the 6 month follow up period will be reported
Eligibility Criteria
Criteria
Inclusion Criteria:
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Consent to participate
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Age >18
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Presence of vasculogenic erectile dysfunction for at least 6 months
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Positive response to PDE5i
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IIEF-ED score > 6 and IIEF score < 26 after wash out of PDE5i
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Abnormal penile triplex-based hemodynamic parameters (peak flow velocity <35cm/sec)
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Stable heterosexual relationship for more than 3 months
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Sexually active and agree to suspend all ED therapy for the duration of study
Exclusion Criteria:
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Any cause of ED other than vascular related
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Previous radiation therapy to pelvis
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History of radical prostatectomy
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Clinically significant chronic haematological disease
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Cardiovascular conditions that prevent sexual activity
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Peyronie's Disease or penile curvature
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History of heart attack, stroke or any life- threatening arrhythmia within the prior 6 month
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Anti-androgens oral or injectables androgens
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Untreated Hypogonadism as demonstrated by abnormal testosterone levels
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Malignancy within the past 5 years
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Any unstable medical, psychiatric condition or spinal cord injury
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Anatomical or neurological abnormalities in the treatment area
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Use of any treatment for ED within 7 days of screening ( oral medications, vacuum devices, constrictive devices, injections or urethral suppositories)
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Known allergy to ultrasound gel
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | G.Gennimatas Hospital | Thessaloniki | Greece | 54621 |
Sponsors and Collaborators
- Institute for the Study of Urological Diseases, Greece
Investigators
- Principal Investigator: Dimitrios Hatzichristou, Prof., Institute for the Study of Urological Diseases (ISUD)
Study Documents (Full-Text)
None provided.More Information
Publications
- Angulo JC, Arance I, de Las Heras MM, Meilán E, Esquinas C, Andrés EM. Efficacy of low-intensity shock wave therapy for erectile dysfunction: A systematic review and meta-analysis. Actas Urol Esp. 2017 Oct;41(8):479-490. doi: 10.1016/j.acuro.2016.07.005. Epub 2016 Aug 10. Review. English, Spanish.
- Gruenwald I, Kitrey ND, Appel B, Vardi Y. Low-Intensity Extracorporeal Shock Wave Therapy in Vascular Disease and Erectile Dysfunction: Theory and Outcomes. Sex Med Rev. 2013 Jul;1(2):83-90. doi: 10.1002/smrj.9. Epub 2015 Oct 18. Review.
- Lu Z, Lin G, Reed-Maldonado A, Wang C, Lee YC, Lue TF. Low-intensity Extracorporeal Shock Wave Treatment Improves Erectile Function: A Systematic Review and Meta-analysis. Eur Urol. 2017 Feb;71(2):223-233. doi: 10.1016/j.eururo.2016.05.050. Epub 2016 Jun 16. Review.
- Rosen RC, Allen KR, Ni X, Araujo AB. Minimal clinically important differences in the erectile function domain of the International Index of Erectile Function scale. Eur Urol. 2011 Nov;60(5):1010-6. doi: 10.1016/j.eururo.2011.07.053. Epub 2011 Jul 30.
- Vardi Y, Appel B, Jacob G, Massarwi O, Gruenwald I. Can low-intensity extracorporeal shockwave therapy improve erectile function? A 6-month follow-up pilot study in patients with organic erectile dysfunction. Eur Urol. 2010 Aug;58(2):243-8. doi: 10.1016/j.eururo.2010.04.004. Epub 2010 May 6.
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