Use of Repris Needle in Bladder Injection

Not Applicable

• Conditions: Overactive Bladder Syndrome
• Interventions: Device: Repris Needle

• Registration Number: NCT04982120
• Lead Sponsor: Uro-1 Medical

Brief 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.

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 Timeline

• Study Start: 2018-10-15
• Status Verified: 2021-07
• Study First Submitted: 2021-07-15
• Study First Submitted QC: 2021-07-28
• Last Update Submitted: 2021-07-28
• Study First Posted: 2021-07-29
• Last Update Posted: 2021-07-29
• Primary Completion: 2022-06-14
• Study Completion: 2022-07-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Repris Needle	Repris Needle	Reprise sheath and needle

Primary Outcome Measures

Name	Time	Method
Procedure Success	1 Day of the procedure	Percentage of subjects with successful injection of medication

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Georgia Urology; 🇺🇸 Cartersville, Georgia, United States