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Comparisonoftwolow-intensity ESWT protocols in patientswitherectiledysfunction
Saffon, JP1; Corredor, HA1; Sandoval, CS1; Martinez, JM1; Buitrago, GC2
1: Boston Medical Group, Colombia; 2: IECAS
Objective:Wecomparedtheefficacyandsafetyoftwofocusedlow-intensityextracorporealshockwavetherapy (Li-ESWT) protocolsforthetreatmentoferectiledysfunction (ED) in thisstudy.
Materials andMethods:Thisis a randomized, experimental, non-inferiorityclinicaltrial. Two Li-ESWT protocolswereevaluated in adult patientswithprimary ED formorethan 3 months in over 50% of sexual intercourses, EHS score underorequalto 3, IIEF-5 score underorequalto 21. Weexcludedpatientswith
bladder, prostateorcoloncancer, Psychogenic ED, psychiatricpathologies, spinal cordinjury, clinicallysuspectedhypogonadism, activeinfections, lesions on thepenisorpubicarea. Protocol 1 consistedoffiveweeklysessions, eachwith 3000 pulsesat 0.15 mJ/mm² and 4 Hz frequency. Protocol 2 consistedofsixsessions, two per week, eachwith 1500 pulsesat 0.10 mJ/mm² and 4 Hz frequency. All patientsweretreatedwiththeDuolith SD 1, Storz Medical AG. The primaryoutcome was the EHS score at 1 month after completingeachprotocol; secondaryoutcomeswere: IIEF-5 at 1, 3 and 6 months after completingeachprotocol. Clinical trialregister NCT02683044.
Results: 178 patientswererecruited, 110 receivedprotocol 1 and 68 protocol 2. Age, comorbidities, and ED durationweresimilar in bothgroups. The baselinescoresofgroup 1 and 2 were: EHS 2.3 vs. 2.4; IIEF-5 13.1 vs. 13.6. A significantimprovement was observed in the EHS score atonemonthoffollow-up in bothprotocols (p <0.001 protocol 1, p = 0.003 protocol 2). Therewerenostatisticallysignificantdifferencesbetweenthegroups in theimprovementofthe EHS score (48.4% protocol 1 vs 43.5% protocol 2, p = 0.6324). The mediansof IIEF-5 scoresweresimilarbetweentheinterventiongroupsat 1, 3 and 6 monthsfollow-up (value p= 0.5221, 0.6650 and 0.3868, respectively). Therewerenoseriousadverseevents/adverseeventsduringthestudy.
Conclusions: The resultssuggestthatthereisnodifference in theefficacybetweenthetwoprotocolsof 5 and 6 sessions.
Disclosure:
Work supportedbyindustry: no.