Tissue Bonding Cystostomy(TBC) (TBC)
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.
|Spinal Cord Injury (SCI) Chronic Urinary Retention Urinary Incontinence||Device: TBC||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Tissue Bonding Cystostomy(TBC)|
- Continuous use [ Time Frame: 12 months ]Continuous use and function of the anchor component for 1+ years following activation
- 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.
|Study Start Date:||May 2017|
|Estimated Study Completion Date:||December 2022|
|Estimated Primary Completion Date:||December 2020 (Final data collection date for primary outcome measure)|
All subjects will undergo the implantation of the 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01771159
|Principal Investigator:||Christopher P. Smith, MD||Baylor College of Medicine|