WithdrawnNot Applicable

Comparison of Pre-procedural PCR and Culture-based UTI Assessment Prior to Intravesical Botox Injection

Stopped: Sponsor's decision

United States0Started 2020-08-15

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion/Exclusion Criteria: * 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

What they're measuring

Post procedural UTI

Timeframe: Up to 3 weeks post injection

Recurrent UTI

Timeframe: Up to 12 months post-injection

Resistant UTI

Timeframe: Up to 12 months post-injection

Antibiotic Usage

Timeframe: Up to 3 weeks post-injection

Visit Reschedule/Cancellation Rate

Timeframe: Up to 1 year after pre-procedural assessment

Trial details

NCT IDNCT04817865

SponsorPathnostics

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-02-10

View on ClinicalTrials.gov More Urinary Tract Infections trials