Twelve-Month Efficacy and Safety of Low-Intensity Shockwave Therapy for Erectile Dysfunction in Patients Who Do Not Respond to Phosphodiesterase Type 5 Inhibitors

Abstract

IntroductionLow-intensity shockwave therapy (LISWT) has recently emerged as a promising method in the treatment of erectile dysfunction (ED).AimTo assess the long-term results of the effectiveness and safety of LISWT in patients with ED who are non-responders to phosphodiesterase type 5 inhibitor (PDE5i) treatment.MethodsThis open-label, longitudinal, and observational study investigated an uncontrolled population of 50 consecutive patients whose ED was unresponsive to PDE5i treatment. Patients were treated with a four-session LISWT protocol. During active treatment and follow-up, all patients remained on their regular high on-demand or once-daily PDE5i dosing schedules.Main Outcome MeasuresEffectiveness was assessed according to the International Index of Erectile Function erectile function domain, questions 2 and 3 of the Sexual Encounter Profile, Erection Hardness Scale, and Global Assessment Question scores at baseline and at 3, 6, 9, and 12 months after treatment. Patients were considered responders whenever they showed improvement in erection parameters in all four assessments and responded positively to the Global Assessment Question. Adverse events were recorded. Statistical variables were applied and findings were considered statistically significant at a P value less than < .05.ResultsEighty percent (mean age = 64.8 years) completed the 12-month follow-up. Positive response rates were 60% of available subjects at the end of the study and 48% of the intent-to-treat population. After the 12-month follow-up, 91.7% of responders maintained their responses. No patient reported treatment-related adverse events.ConclusionLISWT in patients with ED unresponsive to PDE5i treatment was effective and safe in 60% of patients treated. The efficacy response was maintained for 12 months in most patients.

Erectile Dysfunction Treatment Using Focused Linear Low-Intensity Extracorporeal Shockwaves: Single-Blind, Sham-Controlled, Randomized Clinical Trial

“…In our study, the mean change in IIEF-5 was 7.7 points (95% CI 5.9-9.5). Bechara et al [24] studied the efficacy of Li-ESWT in patients unresponsive to treatment with PDE5i and found that Li-ESWT was effective in 60% of Li-ESWT can serve as a salvage therapy for ED patients who failed to respond to PDE5i. Initial severity of ED was an important predictor of a successful response [26].…”

Low intensity shock wave therapy for erectile dysfunction: 6 months followup results

“…Схожие ре-зультаты были отмечены при использовании УВТ при ЭД, резистентной к действию ИФДЭ5 [13]. Сравнительно небольшая доля пациентов, отве-тивших на терапию в нашем исследовании, могла быть обусловлена их особенностями, в частности преобладанием немолодых мужчин (у которых эффект УВТ был достоверно слабее) с умеренной и тяжелой формами ЭД, а также наличием паци-ентов с ЭД диабетического и послеоперационного генеза.…”

Erectile Dysfunction: A Review of Comprehensive Treatment Options for Optimal Outcome

“…148 Another 1 year follow-up of 50 older men (average age 65 years) with vascular risk factors including diabetes, hypertension, dyslipidemia, and coronary artery disease found a 60% sustained improvement in ED severity and self-reported erection quality. 149 The number of LI-ESW treatments for ideal outcome and how long treatment remains effective is not known. A recent RCT performed on 126 men in a Danish hospital compared men who received five versus ten sessions at 6 and 12 months; treatment was approximately 38% effective in both groups, suggesting that additional sessions may not improve outcome.…”