Low Intensity Extracorporeal Shock Wave Treatment Patients With Vasculogenic Erectile Dysfunction: Standardisation of Treatment Protocol
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Erectile Dysfunction
- Sponsor
- Institute for the Study of Urological Diseases, Greece
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- The percent of subjects who achieve clinically important difference (MCID) in the EF domain score of the IIEF
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
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.
Investigators
Dimitrios Hatzichristou
President
Institute for the Study of Urological Diseases, Greece
Eligibility Criteria
Inclusion Criteria
- •Consent to participate
- •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
Outcomes
Primary Outcomes
The percent of subjects who achieve clinically important difference (MCID) in the EF domain score of the IIEF
Time Frame: 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 Outcomes
- Change in Sexual Encounter Profile Question 3 (SEP3) score(baseline, 6 month follow up visit and 12 month follow up visit)
- Number of patients with treatment related adverse events(54 weeks (Group A and Group C), 52 weeks (Group B and Group D))
- Change in the EF domain score of the IIEF(baseline, 6 month follow up visit and 12 month follow up visit)
- Change in mean peak systolic velocity (PSV)(baseline and 3 month follow up visit)