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Urinary Catheter

Connected Catheter for Chronic Urinary Retention

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

Study 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.

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
Select...
I am a man over 22 years old with chronic urinary retention.
Select...
My urinary tract anatomy is suitable for the Connected Catheter device.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Successful Bladder Emptying Using Connected Catheter

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

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this trial currently available to willing subjects?

"According to the clinicaltrials.gov information, this medical trial is recruiting individuals at present. The initial posting of the study occurred on January 27th 2022 and a recent update was made on November 29th 2022."

Answered by AI

How many sites can participants access this research project?

"Currently, there are 6 participating medical facilities in this trial. Examples include Medstar National Rehabilitation Hospital (Washington), UCSD (La Jolla) and West Coast Urology (Inglewood). Additionally, 3 other locations have been added to the study."

Answered by AI

What is the current count of participants enrolled in this clinical research?

"To move forward with this clinical trial, 90 qualifying patients need to be identified. Spinal Singularity is the sponsor of this study and will handle operations out of two locations: Medstar National Rehabilitation Hospital in Washington D.C., and UCSD located in La Jolla, Texas."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Maine
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Urology Austin
Recent research and studies
clinicaltrials.govStudy
Evaluation of the Safety and Clinical Performance of the Connected Catheter Study
2022. "Evaluation of the Safety and Clinical Performance of the Connected Catheter Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05330598.
~8 spots leftby Apr 2025
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