Use of Repris Needle in Bladder Injection

Last updated: July 28, 2021
Sponsor: Uro-1 Medical
Overall Status: Active - Recruiting

Phase

N/A

Condition

Interstitial Cystitis

Treatment

N/A

Clinical Study ID

NCT04982120
Repris Botox Study
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 theprocedure

Exclusion

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 beinjected during the study
  • is pregnant, lactating, or with child-bearing potential unable or unwilling to use areliable 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 theprocedure,
  • unable or unwilling to provide consent

Study Design

Total Participants: 40
Study Start date:
October 15, 2018
Estimated Completion Date:
July 14, 2022

Study 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.

Connect with a study center

  • Georgia Urology

    Cartersville, Georgia 30120
    United States

    Active - Recruiting

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