NCT04982120

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2018

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 29, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2022

Completed
Last Updated

July 29, 2021

Status Verified

July 1, 2021

Enrollment Period

3.7 years

First QC Date

July 15, 2021

Last Update Submit

July 28, 2021

Conditions

Overactive Bladder Syndrome

Outcome Measures

Primary Outcomes (1)

  • Procedure Success

    Percentage of subjects with successful injection of medication

    1 Day of the procedure

Secondary Outcomes (2)

  • Patient Tolerance of Injection

    1 Day of the procedure

  • Adverse Events during Procedure

    Day 0 and Day 5

Study Arms (1)

Repris Needle

EXPERIMENTAL

Reprise sheath and needle

Device: Repris Needle

Interventions

Repris NeedleDEVICE

Injection of Botox

Repris Needle

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOveractive bladder syndrome is more frequently treated in females than males
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgia Urology

Cartersville, Georgia, 30120, United States

RECRUITING

Study Officials

  • Thomas Lawson, PhD

    Uro-1 Medical

    STUDY DIRECTOR

Central Study Contacts

Thomas Lawson, PhD

CONTACT

5102061794drthomlawson@gmail.com

Jack Snoke

CONTACT

3365750434pjsnoke@uro1medical.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2021

First Posted

July 29, 2021

Study Start

October 15, 2018

Primary Completion

June 14, 2022

Study Completion

July 14, 2022

Last Updated

July 29, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will share

Patient identification will not be shared

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Within 7 days after completion of study
Access Criteria
Permission from PI

Locations

US(1)