Effects of naftopidil on double-J stent-related discomfort: a multicenter, randomized, double-blinded, placebo-controlled study

Jong Jin Oh,Ju Hyeon Park,Chang Wook Jeong,Sung Yong Cho,Woong Na,Sang Wook Lee,Sangchul Lee,Seung Bae Lee,Min Chul Cho,Soyeon Ahh

doi:10.1038/s41598-017-04505-y

Abstract

To evaluate the effect of naftopidil 75 mg once daily for ureteral double-J (DJ) stent-related discomfort after a ureteroscopic procedure using a multicenter, randomized, double-blinded, placebo-controlled study. 100 patients with indwelled retrograde DJ ureteral stents after ureteroscopic stone removal or retrograde intrarenal surgery (RIRS) were randomized 1:1 to receive either placebo or naftopidil during the stenting period. At the time of stent removal, the Ureteral Stent Symptom Questionnaire (USSQ), the International Prostate Symptom Score and the total amount of used analgesics were reported. Of the 92 patients who completed the study, 49 patients were enrolled in the placebo group, and 43 patients in the naftopidil group. USSQ urinary symptom scores (30.90 vs. 29.23, p = 0.299) and USSQ body pain scores (22.28 vs. 19.58, respectively, p = 0.286) were lower in the naftopidil group than in the placebo group, but the difference was not significant. Multivariate analysis showed that the use of a ureteral access sheath during RIRS was the only significant predictor of postoperative DJ-related pain (OR = 2.736, p = 0.031). The use of naftopidil once daily did not significantly reduce DJ ureteral stent-related discomfort. Larger-scaled prospective studies should be conducted to evaluate the effects of naftopidil on DJ stent-related symptoms and surgeries.

Highlights

Ureteral stenting has been an established urological procedure for maintaining the patency of ureters since 19671–3
Eighteen patients (51.4%) in the control group and 8 patients (25.8%) in the naftopidil group had increased IPSS scores (p = 0.030). This double-blinded multicenter RCT demonstrated the effect of naftopidil 75 mg once daily on DJ stent-related discomfort
The overall outcomes based on the primary endpoint (i.e., Ureteral Stent Symptom Questionnaire (USSQ) urinary symptoms score and USSQ body pain score) showed no significant effects on the aforementioned symptoms

Summary

Introduction

Ureteral stenting has been an established urological procedure for maintaining the patency of ureters since 19671–3. Other reports have shown that stent-related urinary symptoms and pain have resulted in reduced quality of life (QoL) in up to 80% of patients[4]. Many studies have sought to reduce ureteral stent-related discomfort by investigating the effect of α-blockers, which have shown some beneficial effects in reducing stent-related symptoms[8,9,10,11,12,13,14,15,16]. These studies used tamsulosin or alfuzosin and not naftopidil. Evaluate the effect of naftopidil on improving symptoms and quality of life in patients with indwelling ureteral stents, we used the validated Ureteral Stent Symptom Questionnaire (USSQ)

Methods

Results

Conclusion