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Evaluation of duration of antibiotic prophylaxis for trans rectal prostate biopsy

Single dose versus three day course ofciprofloxacin prophylaxis in transrectal prostate biopsy: a randomized clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/06/007012
Enrollment
60
Registered
2016-06-09
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: N429- Disorder of prostate, unspecified Health Condition 2: null- POST TRANS-RECTAL PROSTATE BIOPSY COMPLICATIONS

Interventions

Intervention1: Group I: Single dose oral ciprofloxacin prophylaxis(500 mg)given at bed time before procedure. Control Intervention1: Group II: Three day ciprofloxacin prophylaxis(500mg BD for 3 days)

Sponsors

University College of Medical Sciences University of Delhi Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All patients aged more than 40 to 80 years in whom transrectal prostate biopsy was indicated and giving informed consent to participate in the study. 2. Patients with indications for transrectal prostate biopsy (PSA >4ng/ml,abnormal/suspicious DRE,symptoms of prostatism, history of prostate carcinoma in first degree relatives)

Exclusion criteria

Exclusion criteria: 1.Patient not willing to give consent for inclusion in the above study. 2.Patient having active untreated genitourinary tract infection (prostatitis, cystitis, Epididymo-orchitis,UTI) 3.Patients with painful, active and untreated anorectal conditions like untreated proctitis, fistula in ano, fissure and hemorrhoids 4. Patients with mental disorders or illness who cannot understand or comply with the study protocol. 5. Patients with known history of allergy to ciprofloxacin therapy.

Design outcomes

Primary

MeasureTime frame
1. To assess positive Urine culture rate in both groups following TR prostate biopsy. 2. To assess pyuria rate in both groups following TR prostate biopsy. 3. To assess hospitalization rates following TR prostate biopsy. 4. To assess positive urine culture rate among two groups.Timepoint: Day 1,2 and 5

Secondary

MeasureTime frame
1. To evaluate pain(VAS score) in patients post TR prostate biopsy . 2. To evaluate post TR prostate biopsy hematuria in patients. 3. To evaluate the bacterial spectrum and antimicrobial sensitivity spectrum of rectal flora in patients undergoing TR prostate biopsy 4. To look for any side effect associated with ciprofloxacin therapy in patients post TR prostate biopsy. Timepoint: Day 3 and 5

Countries

India

Contacts

Public ContactDr Saket Singh

University College of Medical Sciences University of Delhi and GTB Hospital

docsaket89@gmail.com22586262

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026