Use of Repris Needle in Bladder Injection

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a prospective, multicenter, single arm study of the Repris injection needle to administer Botox to the bladder wall in patients with an overactive bladder. Following advancement of a cystoscope to the patient's bladder, the Repris needle will be advanced to the area of interest and into the bladder wall in order to administer the recommended volume of Botox. After injection, the needle will be removed and the procedure will be concluded. The patient will be asked to rank her tolerance of the procedure and level of discomfort using a standardized pain scale before being released. Five days after the procedure the patient will be contacted by telephone to determine whether any adverse events had occurred since release.

Official Title
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A Post-510(k) Study of Patients With Overactive Bladder (OAB) Treated With OnabotulinumtoxinA (Botox, Allergan PLC) Using the Repris Bladder Injection System

Conditions
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Overactive Bladder Syndrome

Intervention / Treatment
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* Device: Repris Needle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Repris Needle<br>Reprise sheath and needle | Device: Repris Needle<br>* Injection of Botox<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure Success | Percentage of subjects with successful injection of medication | 1 Day of the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Tolerance of Injection | Level of pain from use of the needle measured on Likert Scale 1 to 5 | 1 Day of the procedure | 
| Adverse Events during Procedure | Incidence and Severity of Adverse events associated with the injection | Day 0 and Day 5 |