InfectionPhase 4NCT02245334
A Prospective Trial of Povidone-iodine Suppository Before Transrectal Ultrasound Guided Prostate Biopsy
A Phase 4 study testing Povidone-Iodine in people with Infection and Prostatic Diseases, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
To assess the effect of povidone-iodine on infectious complication rate caused by transrectal prostate biopsy Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Infection, Prostatic Diseases, Misadventure During Aspirating Needle Biopsy
- What is being tested?
- Povidone-Iodine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,578 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2014to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- who undergo transrectal prostate biopsy
Who cannot join
- patients who refuse to be included, patients who have hypersensitivity to iodine, patients who have abnormal thyroid function, patients who do not visit follow-up, patients who have received prior radioactive-iodine therapy
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Urology, Seoul National University Bundang Hospital
Seongnam, Gyunggi-do, 463-707
Sangchul Lee, MD, PhD, +82-31-787-7345, uromedi@naver.com
Sangchul Lee, MD, PhD
About this study
Official title: A Prospective Randomized Trial of Povidone-iodine Suppository Before Transrectal Ultrasound Guided Prostate Biopsy
To assess the effect of povidone-iodine on infectious complication rate caused by transrectal prostate biopsy
Read the detailed description
the effect of povidone-iodine on infectious complication rate caused by transrectal prostate biopsy
- Being tested
- Povidone-Iodine
- Medical subject headings
- Infections, Prostatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Povidone-IodineDrug
Also called Gynobetadine
1 pill per biopsy
| Study group | Role | What they receive |
|---|---|---|
| Povidone-iodine | Experimental | povidone iodine pill Receives: Drug: Povidone-Iodine |
| no intervention | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with febrile infection
consider fever over 38 degree celsius or admission due to fever
Measured: 1 week
Secondary outcomes (3)
voiding questionnaire
check International Prostate Symptom Score (IPSS)
Measured: 1-2 week
sexual function questionnaire
International Index of Erectile Function-5 (IIEF-5)
Measured: 1-2 week
quality of life questionnaire
European Organization for Research and Treatment fo Cancer (EORTC) Quality of life Questionnaire (QLQ)-C30 questionnaire
Measured: 1-2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,578 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sangchul Lee, MD.PhD., Principal investigator, Prof
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02245334
- Sponsor's protocol ID
- B-1403/243-004
- Status last verified
- Sep 2014
- First submitted
- 10 Sep 2014
- Last updated
- 22 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial of Povidone-iodine Suppository Before Transrectal Ultrasound Guided Prostate Biopsy
- ClinicalTrials.gov ID
- NCT02245334
- Acronym / sponsor ID
- B-1403/243-004
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,578 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 19 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the effect of povidone-iodine on infectious complication rate caused by transrectal prostate biopsy
Detailed description
the effect of povidone-iodine on infectious complication rate caused by transrectal prostate biopsy
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Povidone-iodine | Experimental | Drug: Povidone-Iodinepovidone iodine pill |
| no intervention | No intervention | –no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- who undergo transrectal prostate biopsy
Key exclusion criteria (1 listed)
- patients who refuse to be included, patients who have hypersensitivity to iodine, patients who have abnormal thyroid function, patients who do not visit follow-up, patients who have received prior radioactive-iodine therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Povidone-IodineAlso: Gynobetadine1 pill per biopsy | Drug | Povidone-iodine |
Primary outcome
Number of participants with febrile infection
Time frame: 1 week
consider fever over 38 degree celsius or admission due to fever
3 secondary outcomes
voiding questionnaire
Time frame: 1-2 week
sexual function questionnaire
Time frame: 1-2 week
quality of life questionnaire
Time frame: 1-2 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sangchul Lee, MD.PhD. principal investigator
Prof
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Povidone-Iodine in people with Infection and Prostatic Diseases, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sangchul Lee (+82-31-787-7345, uromedi@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with febrile infection (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2014.