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

• Sponsor: Spinal Singularity (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05330598
• Collaborator: (none)
• Enrollment: 90
• Locations: 3
• Arm: 1
• Anticipated Duration (Months): 15
• Patients Per Site: 30
• Patients Per Site Per Month: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Retention; Chronic	Device: Connected Catheter	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Prospective, multicenter, single arm trialProspective, multicenter, single arm trial
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Safety and Clinical Performance of the Connected Catheter - Wireless Urinary Prosthesis for Management of Chronic Urinary Retention
• Actual Study Start Date: Jan 27, 2022
• Anticipated Primary Completion Date: Feb 28, 2023
• Anticipated Study Completion Date: Apr 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Connected Catheter Users Device: Connected Urinary Catheter Patients will use the Connected Catheter to empty the bladder during the course of treatment.	Device: 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.

Outcome Measures

Primary Outcome Measures

1. Successful Bladder Emptying Using Connected Catheter [4 weeks]

   During the trial period, and during each test phase visit, the Post-Void Residual (PVR) urine volume is measured via ultrasound. A subject is considered a responder to the device if at least 80% of the subject's available PVR urine volumes using the investigational device (from the trial period and test phase combined) are: Less than or equal to 50mL OR Equal to or less than their baseline PVR when using SOC catheters provided that the baseline PVR is greater than 50mL A subject is considered a nonresponder if neither of these criteria are met. The subject responder rate, R, is estimated as the proportion of subjects who are classified as responders.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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)

7. Urinary tract inflammation or neoplasm

8. Urinary fistula

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

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

11. Impaired kidney function or renal failure

12. Active gross hematuria

13. Active urethritis

14. Bladder stones

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

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

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

18. Catheter Assessment Tool screening yields unacceptable results

19. Vulnerable population such as inmates or developmentally delayed adults

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West Coast Urology, 575 E. Hardy St., Suite 215	Inglewood	California	United States	90301
2	Tri Valley Urology, 25495 Medical Center Dr., Suite 204	Murrieta	California	United States	92562
3	Urology Austin	Austin	Texas	United States	78579

Sponsors and Collaborators

• Spinal Singularity

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Spinal Singularity
• ClinicalTrials.gov Identifier: NCT05330598
• Other Study ID Numbers: CIP-0003
• First Posted: Apr 15, 2022
• Last Update Posted: May 9, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Spinal Singularity: Intermittent Catheter; Intermittent catheterization; Urinary retention; Impaired bladder
• Additional relevant MeSH terms: Urinary Retention

Study Results

No Results Posted as of May 9, 2022