Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2018-10-15
2022-07-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Repris Needle
Reprise sheath and needle
Repris Needle
Injection of Botox
Interventions
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Repris Needle
Injection of Botox
Eligibility Criteria
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Inclusion Criteria
* Able to undergo routine cystoscopy
* Willing to provide verbal assessment of her condition within 5 days after the procedure
Exclusion Criteria
* Presence of a suprapubic catheter or tube due to urethral trauma
* history of interstitial cystitis
* currently being treated for a urinary tract infection (UTI)
* gross hematuria present
* Known allergy or sensitivity to any component of the medication or solution to be injected during the study
* is pregnant, lactating, or with child-bearing potential unable or unwilling to use a reliable form of contraception while participating in the study
* cannot empty her bladder on her own and is routinely catheterizing the urethra
* unable to read, understand, and/or provide a ranking of pain level during the procedure,
* unable or unwilling to provide consent
18 Years
FEMALE
No
Sponsors
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Uro-1 Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas Lawson, PhD
Role: STUDY_DIRECTOR
Uro-1 Medical
Locations
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Georgia Urology
Cartersville, Georgia, United States
Countries
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Central Contacts
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Facility Contacts
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Jeffrey Proctor, MD
Role: primary
Other Identifiers
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Repris Botox Study
Identifier Type: -
Identifier Source: org_study_id
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