Tissue Bonding Cystostomy(TBC)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by Uro-Research, LLC
Sponsor:
Information provided by (Responsible Party):
Uro-Research, LLC
ClinicalTrials.gov Identifier:
NCT01771159
First received: January 15, 2013
Last updated: January 17, 2013
Last verified: January 2013
  Purpose

Spinal Cord Injured [SCI] patients typically cannot "pee". Injury to the spinal cord disrupts the in-coming and out-going brain signals that coordinate bladder sensation and the emptying of bladder. SCI typically causes chronic retention of urine with uncontrolled leakage of urine. Some form of tube (catheter) is needed to drain the urine except with the mildest forms of SCI. Two types of tubes to drain the urine have been used for many years. These types are the urethral (inserted into the bladder through the opening usually used to empty the bladder) and abdominal, called suprapubic cystostomy tubes (put into the bladder through the abdomen).

Bacteria (germs) normally live on our skin. Bacteria have sticky surfaces and so they stick to catheter surfaces. Bacteria reproduce very rapidly from a few dozen to over a million in 24 hours. In a warm liquid environment, like urine, bacteria can reach a density of 10 million per cubic centimeter in 48 hours which causes infection. Oral drugs and antibiotic-coated catheters delay this process by a week or two, but within a month 100% of patients have bacteria in their urine. Existing drugs cannot eliminate these microbial sanctuaries.

The TBC is a 'closed access' abdominal drainage tube that has a 'cuff' or 'anchor'. It is permanently placed in the abdominal muscle to bond with the body's tissue. Another catheter is temporarily connected to the TBC that is easily replaceable in the clinic without anesthesia or special instruments. It locks to form a water-tight system. Many parts of the TBC are coated with an antibacterial substance that will delay the growth of bacteria. The TBC has been used with success in multiple animal studies.

This is a Phase I human clinical trial in which the TBC will be used 10 spinal cord injured patients, each of whom will be followed for 12 months or longer. Abdominal catheter exit sites will be photographed monthly and tested periodically to document growth of any bacteria. Every three months, patients will complete satisfaction questionnaires and their urine will be tested for bacteria. Urine will also be tested as clinically indicated.


Condition Intervention Phase
Spinal Cord Injury (SCI)
Chronic Urinary Retention
Urinary Incontinence
Device: TBC
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tissue Bonding Cystostomy(TBC)

Resource links provided by NLM:


Further study details as provided by Uro-Research, LLC:

Primary Outcome Measures:
  • Continuous use [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Continuous use and function of the anchor component for 1+ years following activation


Secondary Outcome Measures:
  • Chronic microbial colonization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Secondary success is defined as elimination of chronic microbial colonization of urine on three of four follow-up urine cultures made during the planned 1 year follow-up.


Estimated Enrollment: 10
Study Start Date: May 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Population
All subjects will undergo the implantation of the TBC.
Device: TBC

The anchor is capped and surgically implanted in the extra-peritoneal space of the suprapubic region of pubic hair of the lower abdomen using sutures sandwich and secure the anchor between the rectus abdominis muscle and the detrusor [bladder] muscle. Skin is closed over the implant and the bladder is drained with a Foley urethral catheter. The Phase I implant is left in place for 3+ months to allow fibroblasts and collagen from the adjacent muscles to grow into the porous PTFE and effect robust, water--tight bonding of anchor to both rectus and bladder muscles.

After a local anesthesia is injected, the remaining components of the TBC are connected forming a water-tight union of the anchor to the urinary bladder.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 and older that have spinal cord injury and/or chronic, irreversible neuropathic bladder dysfunction from other progressive neurological syndromes including Stroke, multiple sclerosis and Parkinsonism.
  • Candidates must have a minimum duration of injury and bladder dysfunction of 2 years
  • Candidates shall be those who utilize:

    • an indwelling Foley catheter,
    • an indwelling suprapubic catheter,
    • diapers or
    • external (condom) catheter drainage or intermittent self-catheterization but finds the current alternative to be socially unsatisfactory.
  • Candidates need to recognize the investigational nature of the "tissue bonding cystostomy" device and must be willing to return for periodic follow-up.
  • Candidates also need to recognize that a minor surgical procedure may be needed to remove the device if it proves unsatisfactory.
  • Patients must be willing and capable of signing the Informed Consent Document (ICD).
  • In the feasibility study detailed in this protocol only English-speaking subjects will be accepted for participation. If the protocol is expanded then a Spanish-language consent form will be developed and Spanish-speaking candidates will be accepted.

Exclusion Criteria:

  • have a reversible spinal cord injury or a reversible neurological illness
  • have been injured less than two years
  • have acceptable forms of urological management utilizing intermittent self-catheterization, or
  • spontaneous voiding with the use of an external collecting appliance.
  • have no advanced neuropathic bladder dysfunction of less than 2 years duration
  • have advanced neuropathic bladder dysfunction and are happy with intermittent self-catheterization or more traditional forms of tube drainage are non-candidates.
  • This feasibility study will exclude females of child-bearing age. In subsequent expanded clinical trials it may be appropriate [depending on the outcome of the feasibility study] to include females of child-bearing age.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01771159

Sponsors and Collaborators
Uro-Research, LLC
Investigators
Principal Investigator: Christopher P. Smith, MD Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Uro-Research, LLC
ClinicalTrials.gov Identifier: NCT01771159     History of Changes
Other Study ID Numbers: 1
Study First Received: January 15, 2013
Last Updated: January 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Uro-Research, LLC:
Spinal cord injury
Urinary dysfunction
Bladder drainage

Additional relevant MeSH terms:
Spinal Cord Injuries
Urinary Incontinence
Urinary Retention
Central Nervous System Diseases
Lower Urinary Tract Symptoms
Nervous System Diseases
Signs and Symptoms
Spinal Cord Diseases
Trauma, Nervous System
Urination Disorders
Urologic Diseases
Urological Manifestations
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014