Low Intensity Extracorporeal Shock Wave Treatment for Erectile Dysfunction: Standardisation of Treatment Protocol
Study Details
Study Description
Brief Summary
The present study aims to identify the efficacy saturation effect 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. The efficacy and safety of 4 different session frequency protocols will be compared.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This is a randomized, 4 parallel arms, clinical trial with an 18-month recruitment period. All patients will be PDE5I users/responders. After 1 month wash-out period, ED patients will be screened, in order to randomize 96 men with vasculogenic ED, an International Index of Erectile Function ED (IIEF-ED) domain score between 6-25 and abnormal penile triplex-based hemodynamic parameters (peak flow velocity <35cm/sec) in the last 6 months. Additionally, they will be asked to complete the SEP diaries. Patients will be randomized to receive shockwave treatments (12 sessions for all subjects), either twice a week (total of 6 weeks) or three times a week (total of 4 weeks) at energy level 4 or 7, without treatment interval.
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.Also penile dimensions in both flaccid and erect state will be measured.
Visit 2 (day 28 + 3 days): all patients will complete the IIEF-ED domain and will be randomized to one of the four parallel study groups, using an online program. Groups A and C will receive treatment twice per week, at energy level 4 and 7 respectively. Groups B and D will receive treatment three times per week, at energy level 4 and 7 respectively. PDE5i use is prohibited throughout the study.
Treatment Visits: There will be 12 active treatment visits for all 4 Groups. Patients will receive LI-ESWT, according to the study protocol. Interval between 2 treatments will be 3+1 days for Groups A and C (twice/week) whereas 1+1 day for Groups B and D (three times/week). 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 ,24 and 48 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, 24 and 48 there is a + 2 weeks visit window.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Group A Patients will receive 2 sessions of LI-ESWT per week for a 6 week period with energy level 4 (12 sessions totally) |
Device: 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 3 sessions of LI-ESWT per week for a 4 week period with energy level 4 (12 sessions totally) |
Device: 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 C Patients will receive 2 sessions of LI-ESWT per week for a 6 week period with energy level 7 (12 sessions totally) |
Device: 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 D Patients will receive 3 sessions of LI-ESWT per week for a 4 week period with energy level 7 (12 sessions totally) |
Device: 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 [baseline and 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, 6 month follow up visit and 12 month follow up visit]
EF domain of the IIEF questionnaire will be completed
- Change in Sexual Encounter Profile Question 3 (SEP3) score [baseline, 6 month follow up visit and 12 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 [54 weeks (Group A and Group C), 52 weeks (Group B and Group D)]
Potential treatment related adverse events after the first LI-ESWT session and during the 12 month follow up period will be reported
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Consent to participate
-
Age >18
-
Presence of vasculogenic erectile dysfunction for at least 6 months
-
Positive response to PDE5i
-
IIEF-ED score > 6 and IIEF score < 26 after wash out of PDE5i
-
Abnormal penile triplex-based hemodynamic parameters (peak flow velocity <35cm/sec)
-
Stable heterosexual relationship for more than 3 months
-
Sexually active and agree to suspend all ED therapy for the duration of study
Exclusion Criteria:
-
Any cause of ED other than vascular related
-
Previous radiation therapy to pelvis
-
History of radical prostatectomy
-
Clinically significant chronic haematological disease
-
Cardiovascular conditions that prevent sexual activity
-
Peyronie's Disease or penile curvature
-
History of heart attack, stroke or any life- threatening arrhythmia within the prior 6 month
-
Anti-androgens oral or injectables androgens
-
Untreated Hypogonadism as demonstrated by abnormal testosterone levels
-
Malignancy within the past 5 years
-
Any unstable medical, psychiatric condition or spinal cord injury
-
Anatomical or neurological abnormalities in the treatment area
-
Use of any treatment for ED within 7 days of screening ( oral medications, vacuum devices, constrictive devices, injections or urethral suppositories)
-
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
- Clavijo RI, Kohn TP, Kohn JR, Ramasamy R. Effects of Low-Intensity Extracorporeal Shockwave Therapy on Erectile Dysfunction: A Systematic Review and Meta-Analysis. J Sex Med. 2017 Jan;14(1):27-35. doi: 10.1016/j.jsxm.2016.11.001. Epub 2016 Dec 13. Review.
- 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.
- 13771/2016