Therapeutic effect of low-intensity pulsed ultrasound on erectile dysfunction: A multicenter clinical trial
1: , China
Objectives: To investigate the therapeutic effect of low-intensity pulsed ultrasound (LIPUS) on mild to moderate ED patients.
Material and Methods: 120 patients from 5 centers were recruited. Patients were randomized grouped into Control (40 patients) or Treatment (80 patients). Before the first treatment, a four-week wash out period was applied to all the patients to exclude any potential affection of previously received medication. The treatment lasted for 4 weeks, and patients received LIPUS treatment twice a week. Evaluation including International Index of Erectile Function (IIEF-EF, Primary index), Sexual Encounter Profile (SEP)-questionnaires 2/3, Global Assessment Question (GAQ), Erectile Hardness Score (EHS), Erection Quality Scale (EQS), Routine blood test, Routine urine test, VAS score for pain assessment and follow up were conducted 4week, 8week, or 12 week after the treatment.
Results: The overall responsive rate after treatment were 72.5%, 72.5%, and 67.5% respectively at 4, 8, or 12 weeks after the treatment based on the IIEF-EF score, compared to 22.5%, 22.5%, and 20% in Control group (p<0.05 at 3 time points). LIPUS also promote sexual function based on EHS, GAQ, EQS, and SEP2/3. The total adverse events (AEs) recorded were 11 (9 patients) in treatment group and 1 (1 patient) in control group. No AEs related dropouts were recorded.
Conclusions: LIPUS also showed beneficial effect on mild to moderate ED patients based on our clinical trial.
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