Connected Catheter - Safety and Effectiveness Study

Urinary Retention Clinical Trial

Official title:

Evaluation of the Safety and Clinical Performance of the Gen 2 Connected Catheter - Wireless Urinary Prosthesis for Management of Chronic Urinary Retention

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04059159
• Other study ID #: CIP-0002 (formerly ES-NIH-01)
• Status: Terminated
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: April 7, 2021

Study information

• Verified date: December 2022
• Source: Spinal Singularity
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Spinal Singularity 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 35-40 days. This includes five device exchange appointments. The appointments are spaced 7 days apart and at each appointment the catheter will be replaced with a new one. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: April 7, 2021
• Est. primary completion date: March 24, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Males age = 18 with clinical diagnosis of significant urinary retention

2. Must be clinically suitable and capable of safely managing bladder using an intermittent voiding or indwelling strategy

1. Must have stable urinary management history as determined by the investigator OR:

2. Must have urodynamic profile suitable for Gen 2 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 Gen 2 Connected Catheter device, as specified in the Investigational Device Instructions for Use (IFU).

Exclusion Criteria:

1. Active symptomatic urinary tract infection, as defined in this clinical investigation protocol (subjects may receive the device after 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

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 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 Gen 2 Connected Catheter System

10. Catheter Assessment Tool screening yields unacceptable results

Related Conditions & MeSH terms

• Neurogenic Bladder
• Urinary Bladder, Neurogenic
• Urinary Retention
• Urologic Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Rancho Los Amigos Rehabiliation Hospital	Downey	California
United States	UC San Diego	San Diego	California
United States	MedStar National Rehabilitation Hospital	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Spinal Singularity	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Device Related Serious Adverse Events	Rate of participants treated with the Connected Catheter reported with a serious device related adverse event	0 - 49 days
Secondary	Number of Participants With UTI (Occurrence Rate)	Rate of participants treated with the Connected Catheter reported with a symptomatic urinary tract infection	0 - 49 days
Secondary	Number of Participants With Lower Urinary Tract Injury	Rate of participants treated with the Connected Catheter that experience a lower urinary tract injury	0 - 40 days