Back to resultsUse of Repris Needle in Bladder Injection
Primary Purpose
Overactive Bladder Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Repris Needle
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder Syndrome
Eligibility Criteria
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
Sites / Locations
- Georgia UrologyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Repris Needle
Arm Description
Reprise sheath and needle
Outcomes
Primary Outcome Measures
Procedure Success
Percentage of subjects with successful injection of medication
Secondary Outcome Measures
Patient Tolerance of Injection
Level of pain from use of the needle measured on Likert Scale 1 to 5
Adverse Events during Procedure
Incidence and Severity of Adverse events associated with the injection
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04982120
Brief Title
Use of Repris Needle in Bladder Injection
Official Title
A Post-510(k) Study of Patients With Overactive Bladder (OAB) Treated With OnabotulinumtoxinA (Botox, Allergan PLC) Using the Repris Bladder Injection System
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
June 14, 2022 (Anticipated)
Study Completion Date
July 14, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uro-1 Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Repris Needle
Arm Type
Experimental
Arm Description
Reprise sheath and needle
Intervention Type
Device
Intervention Name(s)
Repris Needle
Intervention Description
Injection of Botox
Primary Outcome Measure Information:
Title
Procedure Success
Description
Percentage of subjects with successful injection of medication
Time Frame
1 Day of the procedure
Secondary Outcome Measure Information:
Title
Patient Tolerance of Injection
Description
Level of pain from use of the needle measured on Likert Scale 1 to 5
Time Frame
1 Day of the procedure
Title
Adverse Events during Procedure
Description
Incidence and Severity of Adverse events associated with the injection
Time Frame
Day 0 and Day 5
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Overactive bladder syndrome is more frequently treated in females than males
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Lawson, PhD
Phone
5102061794
Email
drthomlawson@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jack Snoke
Phone
3365750434
Email
pjsnoke@uro1medical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Lawson, PhD
Organizational Affiliation
Uro-1 Medical
Official's Role
Study Director
Facility Information:
Facility Name
Georgia Urology
City
Cartersville
State/Province
Georgia
ZIP/Postal Code
30120
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Proctor, MD
Phone
770-607-1893
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient identification will not be shared
IPD Sharing Time Frame
Within 7 days after completion of study
IPD Sharing Access Criteria
Permission from PI
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Use of Repris Needle in Bladder Injection
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