rectal preparation before prostate biopsy:Normacol versus Povidone iodine versus placebo

Not Applicable

• Conditions: Cancer

• Registration Number: PACTR202202695114430
• Lead Sponsor: Rabta Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-07
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 144

Inclusion Criteria

Patients with a justified indication for biopsy:
*Those with a suspicious digital rectal exam( nodular, hard)
*and/or those with an initial serum PSA level above 4 ng/ml
- Patients whose life expectancy is greater than 10 years

Exclusion Criteria

-Patients with a history of prostate biopsy.
- Patients with a bladder catheter.
- Patients with a contraindication to ciprofloxacin (history of tendinopathy or hypersensitivity to a product of the quinolone family).
- Patients with a contraindication to prostate biopsy (uncorrected coagulation abnormality, untreated urinary tract infection).
- Patients with severe renal or hepatic insufficiency.
- Patients with a life expectancy of less than 10 years.
- Patients with missing data on the medical record

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the occurrence of infectious signs and prostatitis during the 15 days following the b prostate biopsy.;Occurrence of bleeding complication

Secondary Outcome Measures

Name	Time	Method
prevalence of urinary and digestive carriage of germs resistant to fluoroquinilones