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Trial record 2 of 14 for:    baylor college of medicine and anchor

Tissue Bonding Cystostomy(TBC) (TBC)

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. Identifier: NCT01771159
Recruitment Status : Not yet recruiting
First Posted : January 18, 2013
Last Update Posted : May 11, 2016
Information provided by (Responsible Party):
Uro-Research, LLC

Brief Summary:

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 or disease Intervention/treatment Phase
Spinal Cord Injury (SCI) Chronic Urinary Retention Urinary Incontinence Device: TBC Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tissue Bonding Cystostomy(TBC)
Study Start Date : May 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Continuous use [ Time Frame: 12 months ]
    Continuous use and function of the anchor component for 1+ years following activation

Secondary Outcome Measures :
  1. Chronic microbial colonization [ Time Frame: 12 months ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01771159

Sponsors and Collaborators
Uro-Research, LLC
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Principal Investigator: Christopher P. Smith, MD Baylor College of Medicine
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Responsible Party: Uro-Research, LLC Identifier: NCT01771159    
Other Study ID Numbers: 1
First Posted: January 18, 2013    Key Record Dates
Last Update Posted: May 11, 2016
Last Verified: May 2016
Keywords provided by Uro-Research, LLC:
Spinal cord injury
Urinary dysfunction
Bladder drainage
Additional relevant MeSH terms:
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Spinal Cord Injuries
Urinary Incontinence
Urinary Retention
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations