Recruiting

Repris Needle

Sponsor:

Uro-1 Medical

Code:

NCT04982120

Conditions

Overactive Bladder Syndrome

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Repris Needle

Study Details

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.

Conditions

Overactive Bladder Syndrome

Study ID

NCT04982120

Start date

Oct 15, 2018

Status verified date

Jul, 2021

Completion date

Jul 14, 2022

Anticipated

Primary completion date

Jun 14, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Repris Needle

Reprise sheath and needle

Interventions

Repris Needle

Injection of Botox

Primary outcome measure

  • Procedure Success [ Time Frame: 1 Day of the procedure ]

Central Contacts and Locations

Central contacts

Thomas Lawson, PhD

5102061794drthomlawson@gmail.com

Jack Snoke

3365750434pjsnoke@uro1medical.com

Locations

Georgia Urology

Recruiting

Cartersville, Georgia, United States, 30120

Contacts

Jeffrey Proctor, MD

770-607-1893

More Information

Sponsor

Uro-1 Medical

Last update posted

Jul 29, 2021

Last verified

Jul, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Uro-1 Medical on 2021-07-29.