Ningmitai Capsule Facilitates Residual Fragment Clearance after Ureteroscopic Holmium Laser Lithotripsy: A Multicenter Randomized Controlled Trial

Objective To evaluate the efficacy of Ningmitai capsule (NMT), a traditional Chinese medicine, alone or combined with tamsulosin, in promoting residual stone fragment clearance after Ureteroscopic Holmium Laser Lithotripsy (Ho:YAG-URS). Methods In this multicenter, prospective, randomized controlled trial, 222 patients with distal ureteral residual fragments (3.18 ± 1.14 mm) post-Ho:YAG-URS were assigned to three groups: control (no medication), NMT (0.38g × 4 capsules, 3 times/day), or NMT + tamsulosin (0.4 mg/day). Primary outcome was the stone-free rate (SFR) at 4 weeks. Secondary outcomes included stone expulsion rate, stone-free time, and expulsion time. Results At 4 weeks, SFRs were 76.19% (control), 92.21% (NMT; p = 0.023 vs. control), and 98.91% (combination; p < 0.001 vs. control). The combination group achieved significantly shorter stone-free time (6.37 ± 2.25 vs. 15.82 ± 21.62 days, p < 0.0001) and expulsion time (2.27 ± 1.17 vs. 6.64 ± 10.56 days, p < 0.0001) compared to the control group. No drug-related adverse events were reported. Conclusions NMT significantly accelerates residual fragment expulsion post-Ho:YAG-URS, with synergistic effects observed when combined with tamsulosin. This study demonstrates that patients can benefit from Ningmitai capsules alone or combined with tamsulosin, particularly for small fragments where alpha-blockers show limited efficacy.