Evaluation of the Safety and Clinical Performance of the Connected Catheter Study

NCT ID: NCT05330598

Last Updated: 2024-02-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-27
• Study Completion Date: 2024-02-01

Brief Summary

The objective of this study is to evaluate the safety and effectiveness of the Connected Catheter in males with chronic Urinary Retention, both in a clinical setting and an extended period of home use.

The Connected Catheter is a fully internal, urethral indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization. It is a sterile, extended-use device that resides fully internally to the male lower urinary tract for an intended use life of up to 7 days per catheter.

Detailed Description

UroDev Medical has developed the Connected Catheter System to address several drawbacks of urinary catheters. The Connected Catheter is fully internal, indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization. Each subject will use the Connected Catheter for up to 4 weeks including weekly device exchange appointments. Additionally, weekly follow-up will occur for 14 days following the final appointment after the subject discontinues use of study device and reverts to his original catheter.

Conditions

Urinary Retention; Chronic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Connected Catheter Users

Device: Connected Urinary Catheter Patients will use the Connected Catheter to empty the bladder during the course of treatment.

Group Type: EXPERIMENTAL

Connected Catheter

Intervention Type: DEVICE

The Connected Catheter System is a replaceable wireless urinary prosthesis that is indicated for bladder emptying in male patients who have impaired bladder emptying due to chronic Urinary Retention. The Connected Catheter resides fully internally in the male lower urinary tract (urethra and bladder neck) and remains in place for up to 7 days before removal.

Interventions

Connected Catheter

The Connected Catheter System is a replaceable wireless urinary prosthesis that is indicated for bladder emptying in male patients who have impaired bladder emptying due to chronic Urinary Retention. The Connected Catheter resides fully internally in the male lower urinary tract (urethra and bladder neck) and remains in place for up to 7 days before removal.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 1. Males > 22 years old diagnosed with chronic Urinary Retention 2. Must be clinically suitable and capable of safely managing bladder using an intermittent voiding or indwelling catheter strategy:

1. Must have stable urinary management history as determined by the Principal Investigator OR

2. Must have urodynamic profile suitable for the Connected Catheter (including bladder capacity ≥ 200mL without uninhibited bladder contractions) 3. 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.

Exclusion Criteria

• 1. Active symptomatic urinary tract infection, as defined in this clinical investigation plan (CIP)/protocol (subjects may receive the device after their UTI has been treated) 2. Significant risk profile or recent history of urethral stricture (e.g., stricture within past 90 days) 3. Significant risk profile or recent history of clinically significant (uncontrolled) autonomic dysreflexia 4. Significant intermittent urinary incontinence (between catheterizations) 5. Uninhibited bladder contractions and/or Vesicoureteral reflux that is not reliably controlled with medication or alternate therapy (e.g., Botox injection)

1. Active symptomatic urinary tract infection, as defined in this clinical investigation plan (CIP)/protocol (subjects may receive the device after their UTI has been treated)

2. Significant risk profile or recent history of urethral stricture (e.g., stricture within past 90 days)

3. Significant risk profile or recent history of clinically significant (uncontrolled) autonomic dysreflexia

4. Significant intermittent urinary incontinence (between catheterizations)

5. Uninhibited bladder contractions and/or Vesicoureteral reflux that is not reliably controlled with medication or alternate therapy (e.g., Botox injection)

6. Pre-existing urinary pathologies and/or morphological abnormalities of the lower urinary tract or bladder (assessed during in-depth medical screening, including cystoscopy and urine analysis)

1. Urinary tract inflammation or neoplasm

2. Urinary fistula

3. Bladder diverticulum (outpouching) > 5cm in size

4. Chronic pyelonephritis (secondary to upper urinary tract infection(s) within past 6 months)

5. Impaired kidney function or renal failure

6. Active gross hematuria

7. Active urethritis

8. Bladder stones

7. Dependence on an electro-magnetic medical implant (e.g., cardiac pacemaker or implanted drug pump) or external device

8. Any unsuitable comorbidities as determined by the Principal Investigator or complications related to use of certain medications

9. Any physical or cognitive impairments that diminish the subject's ability to follow directions or otherwise safely use the Connected Catheter System

10. Catheter Assessment Tool screening yields unacceptable results

11. Vulnerable population such as inmates or developmentally delayed adults

• Minimum Eligible Age: 22 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Spinal Singularity

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rancho Research Institute

Downey, California, United States

West Coast Urology, 575 E. Hardy St., Suite 215

Inglewood, California, United States

Tri Valley Urology, 25495 Medical Center Dr., Suite 204

Murrieta, California, United States

UCSD

San Diego, California, United States

Medstar National Rehabilitation Hospital

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

CIP-0003

Identifier Type: -

Identifier Source: org_study_id