Use of Repris Needle in Bladder Injection

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04982120
• Other study ID #: Repris Botox Study
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2018
• Est. completion date: July 14, 2022

Study information

• Verified date: July 2021
• Source: Uro-1 Medical
• Contact: Thomas Lawson, PhD
• Phone: 5102061794
• Email: drthomlawson[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Overactive Bladder Syndrome
• Urinary Bladder, Overactive

Intervention

Device:
• Repris Needle
Injection of Botox

Locations

Country	Name	City	State
United States	Georgia Urology	Cartersville	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Uro-1 Medical

Country where clinical trial is conducted

United States, 

Outcome

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