Use of Repris Needle in Bladder Injection

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.

Study Overview

• Status: Recruiting
• Conditions: Overactive Bladder Syndrome
• Intervention / Treatment: Device: Repris Needle

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas Lawson, PhD; Phone Number: 5102061794; Email: drthomlawson@gmail.com
• Study Contact Backup: Name: Jack Snoke; Phone Number: 3365750434; Email: pjsnoke@uro1medical.com

Study Locations

• United States
  • Georgia
    • Cartersville, Georgia, United States, 30120
      • Recruiting
      • Georgia Urology
      • Contact: Jeffrey Proctor, MD; Phone Number: 770-607-1893

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Repris Needle; Reprise sheath and needle	Device: Repris Needle; Injection of Botox

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Uro-1 Medical
• Investigators: Study Director: Thomas Lawson, PhD, Uro-1 Medical

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2018
• Primary Completion (Anticipated): June 14, 2022
• Study Completion (Anticipated): July 14, 2022

Study Registration Dates

• First Submitted: July 15, 2021
• First Submitted That Met QC Criteria: July 28, 2021
• First Posted (Actual): July 29, 2021

Study Record Updates

• Last Update Posted (Actual): July 29, 2021
• Last Update Submitted That Met QC Criteria: July 28, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive
• Other Study ID Numbers: Repris Botox Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Patient identification will not be shared
• IPD Sharing Time Frame: Within 7 days after completion of study
• IPD Sharing Access Criteria: Permission from PI
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No