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Urinary Catheter

Connected Catheter for Chronic Urinary Retention

Austin, TX
N/A
Waitlist Available
Research Sponsored by Spinal Singularity
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males > 22 years old diagnosed with chronic Urinary Retention
Subject's lower urinary tract anatomy must fall within the ranges serviceable by the Connected Catheter device, as specified in the Investigational Device Instructions For Use
Must not have
Urinary tract inflammation or neoplasm
Urinary fistula
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing the safety and effectiveness of the Connected Catheter, a new kind of catheter that resides fully internally for up to 7 days.

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Who is the study for?
This trial is for males over 22 with chronic urinary retention who can manage their bladder using catheters. They must have a stable urinary management history or suitable urodynamic profile (bladder capacity ≥ 200mL) and anatomy that fits the Connected Catheter device.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of the Connected Catheter, a fully internal urinary prosthesis for men with urinary retention, used both in clinical settings and at home for up to 7 days.See study design
What are the potential side effects?
Potential side effects may include discomfort or pain due to catheter use, risk of urinary tract infections, possible inflammation or damage to urethra or bladder from prolonged catheter placement.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a man over 22 years old with chronic urinary retention.
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My urinary tract anatomy is suitable for the Connected Catheter device.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have inflammation or a tumor in my urinary tract.
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I have a urinary fistula.
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I currently have inflammation of the urethra.
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I have a recent history of severe, uncontrolled autonomic dysreflexia.
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I am currently experiencing visible blood in my urine.
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I experience significant urine leakage between using a catheter.
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I have had a narrow urethra issue in the last 3 months.
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I have a bladder outpouching larger than 5cm.
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My kidneys do not work properly.
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I have bladder stones.
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My bladder control issues or kidney reflux are not managed well with medication or treatments like Botox.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Successful Bladder Emptying Using Connected Catheter

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Connected Catheter UsersExperimental Treatment1 Intervention
Device: Connected Urinary Catheter Patients will use the Connected Catheter to empty the bladder during the course of treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Connected Catheter
2018
N/A
~10

Find a Location

Closest Location:Urology Austin· Austin, TX

Who is running the clinical trial?

Spinal SingularityLead Sponsor
4 Previous Clinical Trials
49 Total Patients Enrolled
3 Trials studying Urinary Retention
44 Patients Enrolled for Urinary Retention

Media Library

Connected Catheter (Urinary Catheter) Clinical Trial Eligibility Overview. Trial Name: NCT05330598 — N/A
Urinary Retention Research Study Groups: Connected Catheter Users
Urinary Retention Clinical Trial 2023: Connected Catheter Highlights & Side Effects. Trial Name: NCT05330598 — N/A
Connected Catheter (Urinary Catheter) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05330598 — N/A
~6 spots leftby Mar 2026
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