Use of Repris Needle in Bladder Injection

  • days left to enroll
  • participants needed
  • sponsor
    Uro-1 Medical
Updated on 5 August 2021


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.


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.

Condition Overactive Bladder Syndrome
Treatment Repris Needle
Clinical Study IdentifierNCT04982120
SponsorUro-1 Medical
Last Modified on5 August 2021


Yes No Not Sure

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
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