Efficacy & Safety of Prophylactic Nitrofurantoin Pre-cystoscopy in Preventing UTIs: A Pilot Randomized, Parallel Group, Placebo Controlled Study
摘要
A pilot exploratory study was undertaken with aim of evaluating the efficacy and safety of using nitrofurantoin as a prophylactic agent in preventing UTIs post routine office cystoscopy in a tertiary care teaching hospital setting. Office cystoscopy is a common urological procedure which can occasionally be associated with infectious complications, including urinary tract infections (UTIs). Prophylactic antibiotics are used to prevent these complications, but their necessity and efficacy remain controversial. After obtaining local IEC, bilingual written informed consenta randomized controlled pilot study was conducted at a tertiary care teaching hospital from Nov’ 2019 to Oct’ 2021, involving 62 patients. Patients were computer randomised and assigned to receive either nitrofurantoin (100 mg) or a placebo prior to cystoscopy. The primary outcome was the incidence of UTIs within 14 days post-cystoscopy, while secondary outcomes included morbidity, pain, and treatment emergent adverse events(TEAE). The incidence of UTIs was 6.5% vs. 9.7% in the nitrofurantoin and placebo group respectively (p = 1.000). Pain scores and morbidity were similar in both groups. There were no significant complications, and no treatment emergent adverse events (TEAE) related to nitrofurantoin were reported in this study. The use of nitrofurantoin as a prophylactic agent did not significantly reduce the incidence of UTIs following routine office cystoscopy. The good safety profile of nitrofurantoin with no reported side effects may potentially support its use in judiciously selected cases, but its routine use should be reconsidered based on the overall low incidence of infection in standard procedures as per patient risk assessment and the local hospital antibiogram. Larger randomised controlled studies are definitely requiredto better elucidate and validate the role of antibiotics in preventing post cystoscopy UTIs.