Use of Repris Needle in Bladder Injection

  • STATUS
    Recruiting
  • days left to enroll
    18
  • participants needed
    40
  • sponsor
    Uro-1 Medical
Updated on 5 August 2021

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.

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.

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

Eligibility

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note