INTRODUCTION AND OBJECTIVE: This prospective study aimed to evaluate the effect of ramping and pause protocols on renal fibrosis, blood pressure control, and renal function in patients receivingextracorporeal shockwave lithotripsy (SWL). PATIENTS AND METHODS: This study prospectively recruited 320 patients with solitary radiopaque renal stones <15 mm in size. Patients were randomized to receive one of four shockwave protocols: (1) standard protocol (no ramping or pause); (2) ramping protocol alone; (3) ramping and pause protocols; or (4) pause protocol alone. Spot urine samples were collected before and for 2 years after treatment to monitor the levels of the renal fibrosis marker procollagen III aminoterminal propeptide (PIIINP) by blinded research staffs. Blood pressure and serum creatinine levels were also monitored during follow-up. RESULTS: The four groups had comparable baseline data and treatment parameters. Significant increases (p < 0.05) in the urinary PIIINP levels from 6 weeks until 18 months after SWL were observed among all patients and in individual groups. PIIINP levels peaked at 1 year after SWL and gradually decreased to the baseline at 2 years. At the 2-year follow-up point, the overall serum creatinine levels remained significantly elevated (76.21-80.01 μmol/L, p < 0.001). Twenty (9.95%) patients developed new-onset hypertension and another 43 (36.4%) experienced worsening blood pressure control. However, no differences were observed among the four treatment groups. CONCLUSIONS:SWL led to significant increases in renal fibrosis marker levels for up to 18 months after treatment. However, no differences in changes in renal fibrosis marker and serum creatinine levels and worsening of blood pressure control were observed with respect to the use of either ramping or pause treatment protocols.
RCT Entities:
INTRODUCTION AND OBJECTIVE: This prospective study aimed to evaluate the effect of ramping and pause protocols on renal fibrosis, blood pressure control, and renal function in patients receiving extracorporeal shockwave lithotripsy (SWL). PATIENTS AND METHODS: This study prospectively recruited 320 patients with solitary radiopaque renal stones <15 mm in size. Patients were randomized to receive one of four shockwave protocols: (1) standard protocol (no ramping or pause); (2) ramping protocol alone; (3) ramping and pause protocols; or (4) pause protocol alone. Spot urine samples were collected before and for 2 years after treatment to monitor the levels of the renal fibrosis marker procollagen III aminoterminal propeptide (PIIINP) by blinded research staffs. Blood pressure and serum creatinine levels were also monitored during follow-up. RESULTS: The four groups had comparable baseline data and treatment parameters. Significant increases (p < 0.05) in the urinary PIIINP levels from 6 weeks until 18 months after SWL were observed among all patients and in individual groups. PIIINP levels peaked at 1 year after SWL and gradually decreased to the baseline at 2 years. At the 2-year follow-up point, the overall serum creatinine levels remained significantly elevated (76.21-80.01 μmol/L, p < 0.001). Twenty (9.95%) patients developed new-onset hypertension and another 43 (36.4%) experienced worsening blood pressure control. However, no differences were observed among the four treatment groups. CONCLUSIONS: SWL led to significant increases in renal fibrosis marker levels for up to 18 months after treatment. However, no differences in changes in renal fibrosis marker and serum creatinine levels and worsening of blood pressure control were observed with respect to the use of either ramping or pause treatment protocols.