Clinical trial · Interventional
Infectious Outcomes of Povidone-iodine Rectal Cleansing Plus Formalin Disinfection of Needle During Prostate Biopsy
A Randomized Controlled Trial to Investigate the Infectious Outcomes of Intrarectal Povidone-iodine Cleansing Plus Formalin Disinfection of Needle Tip During Transrectal Ultrasound Guided Prostate Biopsy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main purpose of this study is to compare the infectious outcomes of intrarectal povidone-iodine cleansing plus formalin disinfection of needle tip during transrectal ultrasound guided prostate biopsy. The secondary objective is to evaluate predictive factors of infectious complications after prostate biopsy. Data will be prospectively collected from patients who will undergo prostate biopsy in a single high volume urology center. The patients will be randomized to two different groups: group A - rectal cleansing and disinfection of the needle tip vs group B - controls.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Biopsy | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
| Prostatitis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intrarectal povidone-iodine cleansing plus formalin disinfection of needle tip during transrectal ultrasound guided prostate biopsy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PVPI intervention
- description
- rectal cleansing and disinfection of the needle tip at transrectal ultrasound guided prostate biopsy
- interventionNames
- Other: Intrarectal povidone-iodine cleansing plus formalin disinfection of needle tip during transrectal ultrasound guided prostate biopsy
- type
- NO_INTERVENTION
- label
- Control arm
- description
- controls at transrectal ultrasound guided prostate biopsy
Primary outcomes (1)
- measure
- Infectious complications
- timeFrame
- 1 week
- description
- compare the infectious outcomes of intrarectal povidone-iodine cleansing plus formalin disinfection of needle tip during transrectal ultrasound guided prostate biopsy
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Signature of the consent term; * Agreement with the study follow-up protocol; * Indication of biopsy due to increased PSA (\> 2.5), abnormal rectal touch or patients under active surveillance protocol Exclusion Criteria: * Existence of cognitive deficit that impedes the reading and comprehension of the EHIC; * Allergy to ciprofloxacin or iodine
References
Publications (24)
- BACKGROUNDNoguchi M, Matsuoka K, Koga H, Kanetake H, Nakagawa M, Naito S. A questionnaire survey of patient preparation and techniques for prostate biopsy among urologists in the Kyushu and Okinawa regions of Japan. Int J Clin Oncol. 2006 Oct;11(5):390-5. doi: 10.1007/s10147-006-0592-3. PMID 17058137
- BACKGROUNDSchroder FH, Hugosson J, Roobol MJ, Tammela TL, Zappa M, Nelen V, Kwiatkowski M, Lujan M, Maattanen L, Lilja H, Denis LJ, Recker F, Paez A, Bangma CH, Carlsson S, Puliti D, Villers A, Rebillard X, Hakama M, Stenman UH, Kujala P, Taari K, Aus G, Huber A, van der Kwast TH, van Schaik RH, de Koning HJ, Moss SM, Auvinen A; ERSPC Investigators. Screening and prostate cancer mortality: results of the European Randomised Study of Screening for Prostate Cancer (ERSPC) at 13 years of follow-up. Lancet. 2014 Dec 6;384(9959):2027-35. doi: 10.1016/S0140-6736(14)60525-0. Epub 2014 Aug 6. PMID 25108889
- BACKGROUNDZaytoun OM, Vargo EH, Rajan R, Berglund R, Gordon S, Jones JS. Emergence of fluoroquinolone-resistant Escherichia coli as cause of postprostate biopsy infection: implications for prophylaxis and treatment. Urology. 2011 May;77(5):1035-41. doi: 10.1016/j.urology.2010.12.067. Epub 2011 Mar 21. PMID 21420152
- BACKGROUNDDjavan B, Waldert M, Zlotta A, Dobronski P, Seitz C, Remzi M, Borkowski A, Schulman C, Marberger M. Safety and morbidity of first and repeat transrectal ultrasound guided prostate needle biopsies: results of a prospective European prostate cancer detection study. J Urol. 2001 Sep;166(3):856-60. PMID 11490233
- BACKGROUNDZani EL, Clark OA, Rodrigues Netto N Jr. Antibiotic prophylaxis for transrectal prostate biopsy. Cochrane Database Syst Rev. 2011 May 11;2011(5):CD006576. doi: 10.1002/14651858.CD006576.pub2. PMID 21563156
- BACKGROUNDLindstedt S, Lindstrom U, Ljunggren E, Wullt B, Grabe M. Single-dose antibiotic prophylaxis in core prostate biopsy: Impact of timing and identification of risk factors. Eur Urol. 2006 Oct;50(4):832-7. doi: 10.1016/j.eururo.2006.05.003. Epub 2006 May 16.