Connected Catheter- Safety and Effectiveness Study
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03843073 |
Recruitment Status :
Recruiting
First Posted : February 15, 2019
Last Update Posted : December 31, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Urinary Retention Neurogenic Bladder Urologic Diseases | Device: Connected Urinary Catheter | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 90 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Evaluation of the Safety and Clinical Performance of the Gen 2 Connected Catheter - Wireless Urinary Prosthesis for Management of Chronic Urinary Retention |
Actual Study Start Date : | February 1, 2019 |
Estimated Primary Completion Date : | July 2021 |
Estimated Study Completion Date : | August 2021 |
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. |
- Successful Bladder Emptying Using Connected Catheter [ Time Frame: 35-40 days ]
Rate of participants with successful voiding using the Connected Catheter as assessed by Post-Residual Volume (PVR) measurement via ultrasound
A subject is considered a responder to the treatment if a minimum of 80% of their PVR values met the following criteria
PVR is ≤ 50 mL OR PVR is ≤ baseline PVR with the standard of care catheter
- Rate of device related Serious Adverse Events [ Time Frame: 0 - 40 days ]Rate of participants treated with the Connected Catheter reported with a serious device related adverse event
- Successful device insertion, anchoring, and removal [ Time Frame: 35-40 days ]Rate of Connected Catheter successfully inserted, anchored and removed
- Successful sealing of the catheter valve [ Time Frame: 35-40 days ]Rate of Connected Catheter valves sealed successfully
- Quality of life improvement as measured by SCI-QOL Survey and other surveys [ Time Frame: 35-40 days ]Rate of participants treated with the Connected Catheter with improved overall quality of life as measured by the SCI-QOL Survey and other surveys
- UTI occurrence rate [ Time Frame: 35-40 days ]Rate of participants treated with the Connected Catheter reported with a urinary tract infection
- Lower Urinary Tract injury rate [ Time Frame: 35-40 days ]Rate of participants treated with the Connected Catheter that experience a lower urinary tract injury

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Gender Based Eligibility: | Yes |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Males age ≥ 18 with clinical diagnosis of significant urinary retention
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Must be clinically suitable and capable of safely managing bladder using an intermittent voiding or indwelling strategy
Must have stable urinary management history as determined by the Investigator
OR:
Must have urodynamic profile suitable for the Gen 2 Connected Catheter (including bladder capacity > 200mL without uninhibited bladder contractions)
- 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:
- Active symptomatic urinary tract infection (UTI), as defined in this protocol (subjects may receive the device after 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 (AD)
- 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 injections)
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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
- Dependence on an electro-magnetic medical implant (e.g. cardiac pacemaker or implanted drug pump) or external device
- Any unsuitable comorbidities as determined by the investigator or complications related to use of certain medications
- Any physical or cognitive impairments that diminish the subject's ability to follow directions or otherwise safely use the Connected Catheter System
- Catheter Assessment Tool screening yields unacceptable results

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03843073
Contact: Shannon Metzger | 949-436-7974 | shannon@spinalsingularity.com |
United States, California | |
West Coast Urology, 11411 Brookshire Avenue, Suite 508 | Recruiting |
Downey, California, United States, 90241 | |
Contact: Tiffany Aynehchi 562-923-0706 tiffany@westcoasturology.com | |
Principal Investigator: Ernest Agatstein, MD | |
West Coast Urology, 575 E. Hardy St., Suite 215 | Recruiting |
Inglewood, California, United States, 90301 | |
Contact: Tiffany Aynehchi 562-923-0706 tiffany@westcoasturology.com | |
Principal Investigator: Ernest Agatstein, MD | |
Tri Valley Urology, 25495 Medical Center Dr., Suite 204 | Recruiting |
Murrieta, California, United States, 92562 | |
Contact: Anita Deeds 951-698-1901 ext 232 anita@trivalleyurology.com | |
Principal Investigator: Sreenivas Vemulapalli, MD | |
United States, Maryland | |
Chesapeake Urology | Recruiting |
Owings Mills, Maryland, United States, 21117 | |
Contact: Rayna Bennett-Campbell 443-231-1203 rbennett@chesuro.com | |
Principal Investigator: Andrew Shapiro, MD | |
United States, Minnesota | |
Minnesota Urology, 6025 Lake Road Suite 200 | Recruiting |
Woodbury, Minnesota, United States, 55125 | |
Contact: Diane Kachel 651-999-7032 DKachel@mnurology.com | |
Principal Investigator: Steven Siegel, MD | |
United States, New Jersey | |
New Jersey Urology, 15000 Midlantic Drive, Suite 100 | Recruiting |
Mount Laurel, New Jersey, United States, 08054 | |
Contact: Jennifer Pilallis 856-673-1613 jpilallis@dvullc.com | |
Principal Investigator: Thomas Mueller, MD | |
New Jersey Urology, 2401 Evesham Road, Suite F | Recruiting |
Voorhees, New Jersey, United States, 08043 | |
Contact: Renee Haney 856-673-1613 rhaney@dvullc.com | |
Principal Investigator: Thomas Mueller, MD | |
United States, New York | |
Dr. Jonathan Vapnek Urology | Recruiting |
New York, New York, United States, 10075 | |
Contact: Jonathan Vapnek, MD 212-717-9500 jvapnek@rcn.com | |
United States, Texas | |
Urology San Antonio | Recruiting |
San Antonio, Texas, United States, 78229 | |
Contact: Kethsaly Salinas 210-617-4116 kethsaly.salinas@urologysa.com | |
Principal Investigator: David Talley, MD |
Responsible Party: | Spinal Singularity |
ClinicalTrials.gov Identifier: | NCT03843073 |
Other Study ID Numbers: |
CIP-0001 (Formerly ES-01) |
First Posted: | February 15, 2019 Key Record Dates |
Last Update Posted: | December 31, 2020 |
Last Verified: | December 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Spinal Cord Injury (SCI), Neurogenic Lower Urinary Tract Dysfunction (NLUTD) Catheter associated Urinary Tract Infection (CAUTI) Urinary Catheters |
Urinary Retention Enlarged Prostate Prostate cancer |
Urinary Bladder, Neurogenic Urinary Retention Urologic Diseases Urination Disorders |
Neurologic Manifestations Nervous System Diseases Urinary Bladder Diseases |