PD55-01: Tamsulosin As Medical Expulsive Therapy After Shock Wave Lithotripsy For Renal Stones, A Randomized Controlled Trial (NCT05032287)

Abdelwahab Hashem*, Mahmoud Laymon, Mostafa Elgamal, Doaa Elsayed Sharaf, Ahmed E. Elzalouey, A. M. Elmeniar, Ahmed El-Assmy, Yasser Osman, Khaled Z. Sheir, Mansoura, Egypt

Introduction: Medical expulsive therapy (MET) use after shock wave lithotripsy (SWL) is still controversial . The stone free rate (SFR) in previous trial always overestimated with limited use of computed tomography (CT). Herein we evaluate tamsulosin as MET post-SWL for renal stone using the CT to assess SFR

Methods: A randomized controlled trial (NCT05032287 ) was carried out for renal stone patients amenable for SWL. Patients were allocated after 1st session of SWL to receive tamsulosin 0.4 mg or placebo once daily from the 1st day of SWL and for 3-months or becoming stone free. The primary outcome was SFR, defined by presence of residual fragments (RF) = 3 mm (3C-SFR). No evidence of any residual fragment by NCCT at 3 months (0C-SFR) was assessed. CIRF and CSRF were defined as asymptomatic residual = 3 mm and > 3 mm in maximum diameter, respectively.

Results: Baseline patient data and stone characteristics of the two groups did not differ significantly (Table 1). The 3C-SFR were 73.8% and 59.6% in tamsulosin and placebo groups, respectively (p=0.03). The 0C-SFR was 43% and 15% in tamsulosin and placebo groups, respectively (p < 0.01). The median (IQR) pain scores were 3 (3, 5) and 5 (3, 6) in tamsulosin and placebo groups, respectively (p=0.04)(Table 2). The median time for stone free were 30 days (95% CI: 27.29 - 32.71) in tamsulosin arm, and 36 days (95% CI: 31.01 – 40.99) in placebo arm, HR= 1.42 (95% CI: 1.02 – 1.98) (p=0.03) .

Conclusions: Tamsulosin as MET post SWL facilitates retained residual fragments expulsion, shortens time to reach stone free, and decreases pain scores.

Source of Funding: No