The efficacy and safety of early double J stent placement in treatment of renal tuberculosis: a novel renal function protective strategy

Arm 1: Double J stent placed after starting standard anti-tuberculous drug treatment 2 weeks . Arm 2: Double J stent placed after starting standard anti-tuberculous drug treatment 6 weeks . Standard anti-tuberculous drug treatment : drugs involved:Isoniazide(H), Rifampicin(R),Pyrazinamide(Z) ,Ethambutol(E) dosage amount and dosage frequency:Isoniazide(H), 300mg or 5mg/kg when weight less than 50kg;Rifampicin(R), 600mg or 10mg/kg when weight less than 50kg;Pyrazinamide(Z), 1500mg when weightless than 50kg;2000mg/d when weight greater than or equal to 50kg but less than75kg;2500mg/d when weight greater than or equal to 75kg;Ethambutol(E),25mg/kg, no more than 2000mg a day . The above data are dose for each time. 2HRZ/4HR means initial 2-month intensive phase of treatment with three or four daily rifampicin, isoniazid, pyrazinamide and ethambutol and followed by a 4-month continuation phase with only rifampicin and isoniazid thrice weekly. mode of drug administration:oral Duration:6 months. Double J stent as an ureteral stent will be placed to ipsilateral ureter in both arms, by means of cystoscope or ureteroscope, the duration of the procedure to place it is about 10 minutes. Mode of follow-up management: Arm 1: Beginning standard anti-tuberculous drug treatment; 2 weeks later: Double J stent placed; 3 months later:Follow-up visit to review; 3 months and 2 weeks later: Replacing double J stent; 6 months later: Ending drug treatment ,removing double J stent,review; 9 months later: Follow-up visit to review; 12 months later: Follow-up visit to review; 18 months later: Follow-up visit to review; 24 months later: The last follow-up visit to review. Arm 2: Beginning standard anti-tuberculous drug treatment; 6 weeks later: Double J stent placed; 3 months later:Follow-up visit to review; 4 months and 2 weeks later: Replacing double J stent; 6 months later: Ending drug treatment , removing double J stent, review; 9 months later: Follow-up visit to review; 12 months later: Follow-up visit to review; 18 months later: Follow-up visit to review; 24 months later: The last follow-up visit to review; Participants will be followed as the above schedule till meeting follow-up endpoint events. Items for review include computed tomography (CT), plain film of kidney-ureter-bladder and intravenous pyelography(KUB+IVU), ultrasound, radionuclide imaging, urine routine , erythrocyte sedimentation rate(ESR)and acid-fast bacilli in urine. End point events include: kidney removed; a sever complication occurred due to drugs or surgery need to chang treatment; Participants drop out or death.