A randomized controlled trial of combined low-intensity extracorporeal shockwave therapy and Dapoxetine use in the management of lifelong premature ejaculation
Abstract
We aimed to evaluate the efficacy of combined low-intensity extracorporeal shockwave therapy (LI-ESWT) and dapoxetine administration for the treatment of lifelong premature ejaculation (LPE) in comparison to LI-ESWT and dapoxetine alone. In the randomized controlled trial, 212 men diagnosed with LPE were enrolled. The participants were randomized into four subgroups: control (n = 50), dapoxetine (n = 56), LI-ESWT (n = 50) and LI-ESWT + dapoxetine (n = 56). The intravaginal ejaculation latency (IELT), premature ejaculation profile (PEP), and Global Impression of Change (GIC) were evaluated. There were substantial improvements in the fold-increase of the IELT (F-IELT), and PEP and GIC-I scores in both the dapoxetine (p < 0.001) and LI-ESWT + Dapoxetine (p < 0.001) groups than in the control and LI-ESWT groups. Although the LI-ESWT group demonstrated a minor improvement in the F-IELT score (p = 0.04), there were no noticeable improvements in the PEP (p = 0.12) and GIC-I (p = 0.15) scores. In conclusion, a combination of dapoxetine administration and LI-ESWT might be more effective in treating LPE than LI-ESWT or dapoxetine alone, indicating a potential synergistic effect.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 212 participants or records.
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