Urinary Tract InfectionsPhase 3NCT00177112
Impact of Sterilization Technique on Incidence of Urinary Tract Infection After Cystoscopy
A Phase 3 study testing clean patient preparation for cystoscopy and sterile patient preparation for cystoscopy in people with Urinary Tract Infections, run by University of Minnesota at 1 site in United States.
Trial summary
The purpose of this study is to verify that the incidence rate of urinary tract infections after a routine outpatient cystoscopy is the same for non-sterile (clean) and sterile procedural techniques. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- clean patient preparation for cystoscopy and sterile patient preparation for cystoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 275 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Oct 2007
- Phase
- Phase 3
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Patients undergoing routine outpatient flexible cystoscopy
Who cannot join
- Patients who have had a urinary tract infection within 3 months prior to flexible cystoscopy
- Patients with an indwelling catheter
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to verify that the incidence rate of urinary tract infections after a routine outpatient cystoscopy is the same for non-sterile (clean) and sterile procedural techniques.
- Conditions
- Urinary Tract Infections
- Being tested
- clean patient preparation for cystoscopy, sterile patient preparation for cystoscopy
- Keywords
- Cystoscopy
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clean patient preparation for cystoscopyProcedure or surgery
sterile patient preparation for cystoscopyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
To verify that the incidence rate of urinary tract infections after a routine outpatient cystoscopy is the same for non-sterile (clean) and sterile procedural techniques
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJun 2005
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 275 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Investigators
- Kyle Anderson, MD, Principal investigator, VAMC Minneapolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00177112
- Sponsor's protocol ID
- 0412M65852
- Other IDs
- 3519A
- Status last verified
- Jan 2008
- First submitted
- 13 Sep 2005
- Last updated
- 4 Feb 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sterilization Technique on Incidence of Urinary Tract Infection After Cystoscopy
- ClinicalTrials.gov ID
- NCT00177112
- Acronym / sponsor ID
- 0412M65852
- Conditions
- Urinary Tract Infections
- Keywords
- Cystoscopy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jun 2005
- Study completion
- Oct 2007 (actual)
- First posted
- 15 Sep 2005 (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.
The purpose of this study is to verify that the incidence rate of urinary tract infections after a routine outpatient cystoscopy is the same for non-sterile (clean) and sterile procedural techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age or older
- Patients undergoing routine outpatient flexible cystoscopy
Key exclusion criteria (2 listed)
- Patients who have had a urinary tract infection within 3 months prior to flexible cystoscopy
- Patients with an indwelling catheter
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 |
|---|---|---|
| clean patient preparation for cystoscopy | Procedure or surgery | – |
| sterile patient preparation for cystoscopy | Procedure or surgery | – |
Primary outcome
To verify that the incidence rate of urinary tract infections after a routine outpatient cystoscopy is the same for non-sterile (clean) and sterile procedural techniques
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2008.
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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.
Kyle Anderson, MD principal investigator
VAMC Minneapolis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing clean patient preparation for cystoscopy and sterile patient preparation for cystoscopy in people with Urinary Tract Infections, run by University of Minnesota at 1 site in United States.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 4 Feb 2008. 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 United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To verify that the incidence rate of urinary tract infections after a routine outpatient cystoscopy is the same for non-sterile (clean) and sterile procedural techniques. 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 4 Feb 2008.