Use of Repris Needle in Bladder Injection

NCT ID: NCT04982120

Last Updated: 2021-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-15

Study Completion Date

2022-07-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Overactive Bladder Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Repris Needle

Reprise sheath and needle

Group Type EXPERIMENTAL

Repris Needle

Intervention Type DEVICE

Injection of Botox

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Repris Needle

Injection of Botox

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Uro-1 Medical

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Thomas Lawson, PhD

Role: STUDY_DIRECTOR

Uro-1 Medical

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Georgia Urology

Cartersville, Georgia, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Thomas Lawson, PhD

Role: CONTACT

5102061794

Jack Snoke

Role: CONTACT

3365750434

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jeffrey Proctor, MD

Role: primary

770-607-1893

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Repris Botox Study

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Reduced-dose Botox for Urgency Incontinence Among Elder Females
NCT05512039 ACTIVE_NOT_RECRUITING PHASE1/PHASE2
PTNS vs Botox of Refractory OAB
NCT04451382 TERMINATED