EFFICACY AND SAFETY OF N-ACETYL CYSTEINE IN PREVENTING BIOFILM FORMATION ON URETERAL STENT SURFACE- A PROSPECTIVE RANDOMIZED CONTROL STUDY

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250511001

Enrollment

Registered

2025-05-11

Start date

2022-09-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Tract Infections Biofilms Ureteral Obstruction Ureteral Stents Catheter-Related Infections N-Acetylcysteine Urinary Tract Infections Biofilms Ureteral Obstruction Ureteral Stents Catheter-Related Infections N-Acetylcysteine

Interventions

The test group(I) was administered NAC 600 mg twice daily,control group(II) received a prebiotic capsule containing Streptococcus faecalis (30.0 M), Clostridium butyricum (2.0 M), Bacillus mesentericu

Active Comparator Drug,Placebo Comparator Dietary Supplement

test group(I) ,control group(II)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Undergoing elective or emergency ureteral stenting at the study center Willing and able to provide written informed consent Able to comply with study protocol and follow-up schedule

Exclusion criteria

Exclusion criteria: Known allergy or contraindication to N Acetyl Cysteine Hepatic or renal insufficiency Presence of mental illness affecting protocol compliance Discontinuation of medical treatment during study period

Design outcomes

Primary

Measure	Time frame
significant pyuria 3 weeks, 5weeks, 8 weeks pus cell/hpf in urine samples,ureteral stent surface bio-film 3 weeks, 5weeks, 8 weeks liquid culture medium was vortexed for one minute to facilitate detection of microorganisms attached to the outer surface of the catheter segment.,urine culture 3 weeks, 5weeks, 8 weeks culture,stent tip culture 3 weeks, 5weeks, 8 weeks Stent culture was performed after the removed stent was divided into three parts (top, middle, and bottom) and 2-3 cm pieces from each part were sent for bacteriological investigation	—

Measure

Time frame

significant pyuria 3 weeks, 5weeks, 8 weeks pus cell/hpf in urine samples,ureteral stent surface bio-film 3 weeks, 5weeks, 8 weeks liquid culture medium was vortexed for one minute to facilitate detection of microorganisms attached to the outer surface of the catheter segment.,urine culture 3 weeks, 5weeks, 8 weeks culture,stent tip culture 3 weeks, 5weeks, 8 weeks Stent culture was performed after the removed stent was divided into three parts (top, middle, and bottom) and 2-3 cm pieces from each part were sent for bacteriological investigation

—

Secondary

Measure	Time frame
treatment-emergent adverse effects (TEAEs) 3 weeks, 5weeks, 8 weeks none	—

Countries

India

Contacts

Public ContactHimanshu Agrawal

University College of Medical Sciences (University of Delhi) & GTBH, Shahdara, Delhi-110095. India. Tel: 0091-11-22586262 Ext 2521/2524, Fax: 0091-11-22590495

himagr1987@gmail.com09999472790

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026