Urinary Tract InfectionsNCT04817865
Comparison of Pre-procedural PCR and Culture-based UTI Assessment Prior to Intravesical Botox Injection
An observational study of Urinary Tract Infections, run by Pathnostics at 1 site in United States.
Trial summary
This study is a retrospective record review to determine whether a novel multiplex PCR assay can be utilized as a screening method for UTI in patients receiving Botox injection to treat overactive bladder (OAB). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Multiplex-PCR with Pooled Antibiotic Susceptibility Testing (M-PCR/P-AST) and Urine Culture
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2020to 31 Jul 2023
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients receiving Botox injections for the treatment of neurogenic or non-neurogenic OAB
Who may be able to join
- Subject is male or female
- >18 years of age at date of injection
- Subject receiving BoNT injection for symptoms of OAB (including urgency, urinary incontinence, and detrusor overactivity) refractory to first-line therapies
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Urologic Care
Barrington, Illinois, 60010
About this study
Official title: A Retrospective Comparison of Pre-procedural PCR and Culture-based UTI Assessment Prior to Intravesical Botox for the Treatment of Neurogenic or Non-neurogenic Overactive Bladder
This study is a retrospective record review to determine whether a novel multiplex PCR assay can be utilized as a screening method for UTI in patients receiving Botox injection to treat overactive bladder (OAB).
Read the detailed description
The novel multiplex real-time PCR assay with mixed floral antibiotic resistance profiling offers a higher degree of sensitivity and specificity than conventional culture methods in the identification of UTI pathogens as determined by a previous prospective comparison study. This is a retrospective record review comparing PCR and culture-based assessments for UTI in patients receiving Botox injection to treat overactive bladder (OAB). Investigators aim to determine whether M-PCR/P-AST can be utilized as a screening method for UTI in these patients and whether whether antibiotic prophylaxis, peri-procedural antibiotics, and post-injection antibiotic therapy based on patients' pre-procedural M-PCR/P-AST results in improved response to Botox injection compared to standard of care. The attributes and advantages of PCR testing over the use of traditional urine cultures, and the potential identification of polymicrobial infections with complicated resistance sharing mechanisms, may significantly improve patient care.
- Conditions
- Urinary Tract Infections
- Being tested
- Multiplex-PCR with Pooled Antibiotic Susceptibility Testing (M-PCR/P-AST), Urine Culture
- Keywords
- Overactive Bladder, PCR, Urine Culture, Botox Injection
- Medical subject headings
- Urinary Tract Infections, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiplex-PCR with Pooled Antibiotic Susceptibility Testing (M-PCR/P-AST)Diagnostic test
M-PCR/P-AST is a dual assessment test that detects pathogenic DNA commonly associated with urinary tract infections and identifies their genotypic and phenotypic antibiotic resistance.
Urine CultureDiagnostic test
A traditional clinical UTI evaluation consisting of non-molecular standard urine culture (SUC) and sensitivity testing methods.
| Study group | Role | What they receive |
|---|---|---|
| Standard Pre-Procedural Urine Culture | This is a control cohort that follows standard pre-procedural protocol by implementing antibiotic prophylaxis and treatment regimens based on dipstick urine analysis (UA) followed by reflexed traditional urine culture and sensitivity (C\&S) methods performed before injection. Receives: Diagnostic Test: Urine Culture | |
| Pre-Procedural M-PCR/P-AST | This is an experimental cohort that implements Multiplex-PCR with Pooled Antibiotic Susceptibility Testing (M-PCR/P-AST) for pre-procedural UTI screening. The cohort follows an antibiotic treatment regimen based on the results of M-PCR/P-AST. Receives: Diagnostic Test: Multiplex-PCR with Pooled Antibiotic Susceptibility Testing (M-PCR/P-AST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post procedural UTI
Defined as development of UTI confirmed by urine culture/PCR in the setting of UTI symptoms requiring antibiotic therapy
Measured: Up to 3 weeks post injection
Recurrent UTI
Defined as the development of multiple UTI confirmed by urine culture/PCR in the setting of UTI symptoms requiring antibiotic therapy
Measured: Up to 12 months post-injection
Resistant UTI
Defined as UTI that manifests as a persistence or worsening of symptoms during antibiotic course
Measured: Up to 12 months post-injection
Antibiotic Usage
Defined as total number of post-procedural antibiotics ordered/taken within 3 weeks post BOTOX injection
Measured: Up to 3 weeks post-injection
Visit Reschedule/Cancellation Rate
Defined as any injection visit cancelled/postponed/rescheduled due to results of preprocedural assessments (abnormal UA, lower urinary tract symptoms etc.)
Measured: Up to 1 year after pre-procedural assessment
Secondary outcomes (2)
UTI-related ED Visit Rate
Defined as any visit to the ED relating to symptoms of UTI within 3 weeks post-Botox injection
Measured: Up to 3 weeks post-injection
UTI-hospital Admission Rate
Defined as any admission to the hospital (from home/ED or clinic transfer) relating to symptoms of UTI within 3 weeks post-Botox injection
Measured: Up to 3 weeks post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start15 Aug 2020
- Primary completion10 Feb 2021
- Study completion31 Jul 2023
Why it stopped: Sponsor's decision
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pathnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Baunoch, PhD, Principal investigator, Pathnostics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817865
- Sponsor's protocol ID
- 2020-btxuti
- Status last verified
- Nov 2023
- First submitted
- 23 Mar 2021
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Comparison of Pre-procedural PCR and Culture-based UTI Assessment Prior to Intravesical Botox for the Treatment of Neurogenic or Non-neurogenic Overactive Bladder
- ClinicalTrials.gov ID
- NCT04817865
- Acronym / sponsor ID
- 2020-btxuti
- Conditions
- Urinary Tract Infections
- Keywords
- Overactive Bladder, PCR, Urine Culture, Botox Injection
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Sponsor's decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PathnosticsIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- 10 Feb 2021 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 26 Mar 2021 (actual)
- 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.
This study is a retrospective record review to determine whether a novel multiplex PCR assay can be utilized as a screening method for UTI in patients receiving Botox injection to treat overactive bladder (OAB).
Detailed description
The novel multiplex real-time PCR assay with mixed floral antibiotic resistance profiling offers a higher degree of sensitivity and specificity than conventional culture methods in the identification of UTI pathogens as determined by a previous prospective comparison study. This is a retrospective record review comparing PCR and culture-based assessments for UTI in patients receiving Botox injection to treat overactive bladder (OAB). Investigators aim to determine whether M-PCR/P-AST can be utilized as a screening method for UTI in these patients and whether whether antibiotic prophylaxis, peri-procedural antibiotics, and post-injection antibiotic therapy based on patients' pre-procedural M-PCR/P-AST results in improved response to Botox injection compared to standard of care. The attributes and advantages of PCR testing over the use of traditional urine cultures, and the potential identification of polymicrobial infections with complicated resistance sharing mechanisms, may significantly improve patient care.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Pre-Procedural Urine Culture | – | Diagnostic Test: Urine CultureThis is a control cohort that follows standard pre-procedural protocol by implementing antibiotic prophylaxis and treatment regimens based on dipstick urine analysis (UA) followed by reflexed traditional urine culture and sensitivity (C\&S) methods performed before injection. |
| Pre-Procedural M-PCR/P-AST | – | Diagnostic Test: Multiplex-PCR with Pooled Antibiotic Susceptibility Testing (M-PCR/P-AST)This is an experimental cohort that implements Multiplex-PCR with Pooled Antibiotic Susceptibility Testing (M-PCR/P-AST) for pre-procedural UTI screening. The cohort follows an antibiotic treatment regimen based on the results of M-PCR/P-AST. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving Botox injections for the treatment of neurogenic or non-neurogenic OAB
Key inclusion criteria (3 listed)
- Subject is male or female
- >18 years of age at date of injection
- Subject receiving BoNT injection for symptoms of OAB (including urgency, urinary incontinence, and detrusor overactivity) refractory to first-line therapies
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Multiplex-PCR with Pooled Antibiotic Susceptibility Testing (M-PCR/P-AST)M-PCR/P-AST is a dual assessment test that detects pathogenic DNA commonly associated with urinary tract infections and identifies their genotypic and phenotypic antibiotic resistance. | Diagnostic test | Pre-Procedural M-PCR/P-AST |
| Urine CultureA traditional clinical UTI evaluation consisting of non-molecular standard urine culture (SUC) and sensitivity testing methods. | Diagnostic test | Standard Pre-Procedural Urine Culture |
Primary outcome
Post procedural UTI
Time frame: Up to 3 weeks post injection
Defined as development of UTI confirmed by urine culture/PCR in the setting of UTI symptoms requiring antibiotic therapy
Recurrent UTI
Time frame: Up to 12 months post-injection
Defined as the development of multiple UTI confirmed by urine culture/PCR in the setting of UTI symptoms requiring antibiotic therapy
Resistant UTI
Time frame: Up to 12 months post-injection
Defined as UTI that manifests as a persistence or worsening of symptoms during antibiotic course
Antibiotic Usage
Time frame: Up to 3 weeks post-injection
Defined as total number of post-procedural antibiotics ordered/taken within 3 weeks post BOTOX injection
Visit Reschedule/Cancellation Rate
Time frame: Up to 1 year after pre-procedural assessment
Defined as any injection visit cancelled/postponed/rescheduled due to results of preprocedural assessments (abnormal UA, lower urinary tract symptoms etc.)
2 secondary outcomes
UTI-related ED Visit Rate
Time frame: Up to 3 weeks post-injection
UTI-hospital Admission Rate
Time frame: Up to 3 weeks post-injection
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
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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.
David Baunoch, PhD principal investigator
Pathnostics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infections, run by Pathnostics 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 3 inclusion and 0 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: withdrawn, as of the sponsor's last update on 18 Nov 2023. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Post procedural UTI (time frame: Up to 3 weeks post injection). The study lists 5 primary outcomes in all. 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 18 Nov 2023.