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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202202695114430
Enrollment
144
Registered
2022-02-03
Start date
2019-01-01
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

Cancer

Interventions

No rectal preparation

Sponsors

Rabta Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
the occurrence of infectious signs and prostatitis during the 15 days following the b prostate biopsy.;Occurrence of bleeding complication

Secondary

MeasureTime frame
prevalence of urinary and digestive carriage of germs resistant to fluoroquinilones

Countries

Tunisia

Contacts

Public ContactMoez Rahoui

Urology Departement

rmoez099@gmail.com+21628121424

Outcome results

None listed

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