Use of Repris Needle in Bladder Injection

Status unconfirmed · Not applicable

Conditions studied: Overactive Bladder Syndrome

In brief

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.

Key facts

Study ID

NCT04982120

Run by

Uro-1 Medical

People needed

40

Starts

2018-10-15

Expected to finish

2022-07-14

Last updated by the study team

2021-07-29

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Georgia Urology — Cartersville, Georgia, United States (enrolling)

Full record on ClinicalTrials.gov

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