Overactive Bladder Syndrome Clinical Trial
Official title:
A Post-510(k) Study of Patients With Overactive Bladder (OAB) Treated With OnabotulinumtoxinA (Botox, Allergan PLC) Using the Repris Bladder Injection System
Treatment of overactive bladder (OAB) has been treated successfully by the injection of Botox. The Repris injection needle has a deflection that may assist in injection difficult to reach with standard straight needles. This study will assess the success, safety and patient tolerance of this new injection needle.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | July 14, 2022 |
Est. primary completion date | June 14, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult (18 years of age or older) - Able to undergo routine cystoscopy - Willing to provide verbal assessment of her condition within 5 days after the procedure Exclusion Criteria: - History of urethral strictures - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Georgia Urology | Cartersville | Georgia |
Lead Sponsor | Collaborator |
---|---|
Uro-1 Medical |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Procedure Success | Percentage of subjects with successful injection of medication | 1 Day of the procedure | |
Secondary | Patient Tolerance of Injection | Level of pain from use of the needle measured on Likert Scale 1 to 5 | 1 Day of the procedure | |
Secondary | Adverse Events during Procedure | Incidence and Severity of Adverse events associated with the injection | Day 0 and Day 5 |
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