Tissue Bonding Cystostomy(TBC)

NCT01771159 | Unknown Phase 1

• 1 other identifier: 1
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Spinal Cord Injury (SCI); Chronic Urinary Retention; Urinary Incontinence

Keywords

Spinal cord injury; Urinary dysfunction; Bladder drainage

Outcome Measures

Primary Outcomes (1)

• Continuous use

  Continuous use and function of the anchor component for 1+ years following activation

  12 months

Secondary Outcomes (1)

• Chronic microbial colonization

  12 months

Study Arms (1)

Population

EXPERIMENTAL

All subjects will undergo the implantation of the TBC.

Device: TBC

Interventions

TBC DEVICE

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.

Population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uro-Research, LLC: lead

MeSH Terms

Conditions

Spinal Cord Injuries; Urinary Incontinence

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher P. Smith, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2013
• First Posted: January 18, 2013
• Study Start: May 1, 2017
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2022
• Last Updated: May 11, 2016

Record last verified: 2016-05