6 vs 12 Sessions in Low Intensity Extracorporeal Shock Wave Treatment (LI-ESWT) for Erectile Dysfunction (ED)
NCT ID: NCT03089307
Last Updated: 2017-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2015-08-18
2016-09-13
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
Patients will receive one session of low intensity extracorporeal shock wave treatment (LI-ESWT) per week for 6 weeks (6 sessions totally).
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).
Group B
Patients will receive two sessions of low intensity extracorporeal wave treatment (LI-ESWT) per week for 6 weeks (12 sessions totally).
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
2. Age \>18
3. Presence of vasculogenic erectile dysfunction for at least 6 months
4. Positive response to PDE5i
5. IIEF-ED score \> 6 and IIEF score \< 26 after wash out of PDE5i
6. Abnormal penile triplex-based hemodynamic parameters (peak flow velocity \<35cm/sec)
7. Stable heterosexual relationship for more than 3 months
8. Sexually active and agree to suspend all ED therapy for the duration of study
Exclusion Criteria
2. Previous radiation therapy to pelvis
3. History of radical prostatectomy
4. Clinically significant chronic haematological disease
5. Cardiovascular conditions that prevent sexual activity
6. Peyronie's Disease or penile curvature
7. History of heart attack, stroke or any life- threatening arrhythmia within the prior 6 month
8. Anti-androgens oral or injectables androgens
9. Untreated Hypogonadism as demonstrated by abnormal testosterone levels
10. Malignancy within the past 5 years
11. Any unstable medical, psychiatric condition or spinal cord injury
12. Anatomical or neurological abnormalities in the treatment area
13. Use of any treatment for ED within 7 days of screening ( oral medications, vacuum devices, constrictive devices, injections or urethral suppositories)
14. Known allergy to ultrasound gel
18 Years
MALE
No
Sponsors
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Institute for the Study of Urological Diseases, Greece
OTHER
Responsible Party
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Dimitrios Hatzichristou
President
Principal Investigators
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Dimitrios Hatzichristou, Prof.
Role: PRINCIPAL_INVESTIGATOR
Institute for the Study of Urological Diseases (ISUD)
Locations
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G.Gennimatas Hospital
Thessaloniki, , Greece
Countries
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References
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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.
Angulo JC, Arance I, de Las Heras MM, Meilan E, Esquinas C, Andres 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. English, Spanish.
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.
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.
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.
Other Identifiers
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1490/15
Identifier Type: -
Identifier Source: org_study_id