Efficacy and safety of N-acetylcysteine vs. probiotics in in-vivo biofilm prevention on ureteral stents: a prospective randomized controlled pilot in vivo study.

2025-08-11
International urology and nephrology 58(3)
- Iqbal Singh
- Himanshu Agrawal
- Shailender Maurya
- Himanshu Tanwar
- Sanjay Gupta
- N P Singh

PubMed: 40788469
DOI: 10.1007/s11255-025-04713-w

Study Design

Type: Randomized Controlled Trial (RCT)
Population: 60 patients undergoing ureteral stent placement
Methods: Prospective, open-label, randomized controlled experimental study, 5 weeks of NAC 600 mg twice daily vs. probiotics
Blinding: Open-label
Duration: 5 weeks
Funding: Unclear

Objective

To evaluate the efficacy and safety of N-acetylcysteine (NAC) vs. probiotics in preventing biofilm formation on ureteral stents in selected patients. Ureteral stents are essential for managing urinary obstructions and renal stones and are prone to complications such as biofilm formation, which can lead to infections and stent malfunction. NAC is known for its mucolytic and antimicrobial properties, has shown potential in preventing biofilm formation on ureteral stents; however, clinical evidence is limited.

Methods

This prospective, open-label, randomized controlled experimental study was conducted in a tertiary care teaching hospital between October 2022 and March 2024. Sixty patients undergoing ureteral stent placement were randomized to receive NAC (600 mg twice daily) in Group I vs. probiotics (containing Streptococcus faecalis, Clostridium butyricum, Bacillus mesentericus, and Lactic Acid Bacillus) in Group II for 5 weeks. Primary outcomes included routine urine microscopy, culture, stent culture, and biofilm detection on the stent surfaces.

Results

Group I showed significantly reduced (pyuria, positive urine cultures, and biofilm formation on stents) to group II. Biofilm was absent in group I but was detected in 6.7% of group II. No significant treatment-emergent adverse effects (TEAEs) were observed in either group.

Conclusion

NAC demonstrated a strong potential in preventing biofilm formation on ureteral stents, which correlated with improved outcomes in terms of reduced stent-associated bacterial growth, bacteriuria, and pyuria. However, further studies with larger sample sizes and longer follow-up periods are needed to confirm these findings and assess the precise utility and long-term safety of NAC in clinical settings for ureteral stenting and UTIs.

Drug trial registry

TCTR20250511001 dt 11th May '2025, https://www.thaiclinicaltrials.org/show/TCTR20250511001.

Research Insights

N-Acetyl Cysteine→Reduced Biofilm Formation
Biofilm was absent in group I but was detected in 6.7% of group II.
Effect
Beneficial
Effect size
Large
Dose
600 mg twice daily
N-Acetyl Cysteine→Reduced Biofilm Formation on Stents
Biofilm was absent in group I but was detected in 6.7% of group II.
Effect
Beneficial
Effect size
Large
Dose
600 mg twice daily
N-Acetyl Cysteine→Reduced Positive Urine Culture
Group I showed significantly reduced (pyuria, positive urine cultures, and biofilm formation on stents) to group II.
Effect
Beneficial
Effect size
Small
Dose
600 mg twice daily
N-Acetyl Cysteine→Reduced Pyuria
Group I showed significantly reduced (pyuria, positive urine cultures, and biofilm formation on stents) to group II.
Effect
Beneficial
Effect size
Small
Dose
600 mg twice daily

Adverse Events Reported

N-Acetyl Cysteine→Overall tolerability
No significant treatment-emergent adverse effects (TEAEs) were observed in either group.
Finding
Reported