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

NCT05330598 | Terminated DMC FDA Device

• 1 other identifier: CIP-0003
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 5

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.

Conditions

Urinary Retention; Chronic

Keywords

Intermittent Catheter; Intermittent catheterization; Urinary retention; Impaired bladder

Outcome Measures

Primary Outcomes (1)

• Successful Bladder Emptying Using Connected Catheter

  PVR Responder Rate, defined as either: * Less than or equal to 50mL OR * Equal to or less than their baseline PVR when using SOC catheters The subject responder rate, R, is estimated as the proportion of subjects who are classified as responders.

  4 weeks

Study Arms (1)

Connected Catheter Users

EXPERIMENTAL

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

Device: Connected Catheter

Interventions

Connected Catheter 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.

Connected Catheter Users

Eligibility Criteria

• Age: 22 Years+
• Gender Eligibility Details: The connected catheter is designed for male use.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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:
• Must have stable urinary management history as determined by the Principal Investigator OR
• 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.

You may not qualify if:

• \. 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)
• 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)
• Significant risk profile or recent history of urethral stricture (e.g., stricture within past 90 days)
• Significant risk profile or recent history of clinically significant (uncontrolled) autonomic dysreflexia
• Significant intermittent urinary incontinence (between catheterizations)
• Uninhibited bladder contractions and/or Vesicoureteral reflux that is not reliably controlled with medication or alternate therapy (e.g., Botox injection)
• 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)
• Urinary tract inflammation or neoplasm
• Urinary fistula
• Bladder diverticulum (outpouching) \> 5cm in size
• Chronic pyelonephritis (secondary to upper urinary tract infection(s) within past 6 months)
• Impaired kidney function or renal failure
• Active gross hematuria
• Active urethritis
• Bladder stones

Sponsors & Collaborators

• Spinal Singularity: lead

Study Sites (5)

Rancho Research Institute

Downey, California, 90242, United States

Location

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

Inglewood, California, 90301, United States

Location

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

Murrieta, California, 92562, United States

Location

UCSD

San Diego, California, 92103, United States

Location

Medstar National Rehabilitation Hospital

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Urinary Retention; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multicenter, single arm trial

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: April 15, 2022
• Study Start: January 27, 2022
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)