Botulinum-A Toxin Injection for Detrusor Hyperreflexia in Spinal Cord Injury: A Non-Surgical Approach.

June 25, 2015 updated by: US Department of Veterans Affairs
The purpose of the study is to determine whether Botulinum-A toxin injected in the bladder muscle will help prevent the frequency and degree of urinary incontinence in Spinal Cord Injured and Multiple Sclerosis patients. The proposed mechanism would be that the Toxin would allow the bladder to hold more urine at a lower pressure as determined by Urodynamics. The research will answer the question whether the dosages 300 units vs 400 units are either equally vs not equally effective in helping urinary incontinece and bladder storage.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVE OF THE PROJECT The major aim of the present study is to use a double blind randomized clinical trial design to evaluate the long-term efficacy and safety of two different doses, 300 and 400 Units of Botulinum Toxin Type-A for the treatment of detrusor hyperreflexia (Neurogenic Bladder Overactivity). While also improving bladder capacity in spinal cord injured patients with refractory symptoms who have failed anticholinergic agents.

RESEARCH PLAN Inclusion Criteria: Male and female subjects 18-80 years of age with suprasacral SCI refractory NBOA incontinence, and/or impaired detrusor compliance associated with a small bladder capacity will be eligible. Subjects will be recruited on the basis of incontinence symptoms and adverse urodynamic parameters including impaired bladder compliance less than 50ml/cm, H20 and bladder (cystometric) capacity less than 300 ml.

Exclusion criteria: Allergy to Botulinum Toxin Type-A, pregnancy, breast-feeding women, active medical or psychiatric disorders, active urinary tract infection, coagulopathy, myasthenia gravis, upper urinary tract changes unrelated to lower tract dysfunction, and aminoglycoside use during the last three months. Furthermore, subjects with radiation cystitis (by history), vesico-ureteral reflux (by videofluoroscopy), bladder calculi (by cystoscopy) will be excluded.

Evaluation will include history and physical examination, urine analysis, urine culture and sensitivity, 24-hour voiding diary for 3 consecutive days, urine pregnancy test in female subjects of reproductive age, validated questionnaires, multichannel videourodynamics (UDS), post-void residual volume at the time of UDS, and renal ultrasound.

METHODOLOGY One week after the pre-intervention evaluation, endoscopic injection of Botulinum Toxin Type-A (300 Units or 400 Units) into the detrusor muscle will be performed. During the 24 month duration of the study, participants will take and record their regular bladder medications as Dr. Gousse (or one of his assistants) decide necessary to control their urinary symptoms. Subjects will be scheduled to return at 2, 6, and 12 weeks after the first injection session, and every 3 months thereafter. At the 2-week visit we will assess untoward effects. At the 6-week visit and every subsequent visit a focused physical examination will be carried out, along with validated questionnaires.

Participants with initial success, as defined by 50% improvement (voiding diary) in diminished leakage, improved cystometric capacity by greater than 100 ml, improved compliance by 15 ml/cm H20, 50% improvement in questionnaire scores, but who lose the initial therapeutic benefit will be considered candidates for re-injection every 6 months. Patients who continue to maintain therapeutic benefit pass 6 months after initial injection will not be re-injected and will be re-evaluated at every 3 months thereafter prior to possible re-injection. Pregnancy testing will be obtained prior to each injection session in appropriate female subjects in their reproductive years.

Depending on the type of variable being analyzed different statistical techniques will be used for these comparisons including paired sample t-tests, Wilcoxon's signed rank tests, McNemar's tests, and Cochran's Q tests. Cross-sectional as well as longitudinal analyses will be performed to compare 300 vs. 400 Unit groups with respect to each of the variables ascertained at each time point, and also with respect to changes over time for the major study end points.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33125
        • Miami VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must be 18-80 years old with suprasacral spinal cord injury (SCI) or multiple sclerosis (MS) refractory Neurogenic bladder overactivity and/or detrusor compliance associated with small bladder capacity.· Impaired bladder compliance less than 50 ml/cm, H2O and bladder (cystometric) capacity less than 300ml.-

Exclusion Criteria:

  • Allergy to Botulinum Toxin Type-A· Pregnancy· Breast-feeding women· Active medical or psychiatric disorders· Upper urinary tract changes unrelated to lower tract dysfunction· Aminoglycoside use during the last 3 months-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Investigators

  • Principal Investigator: Angelo E Gousse, MD, Miami VA Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

December 2, 2005

First Submitted That Met QC Criteria

December 2, 2005

First Posted (Estimate)

December 6, 2005

Study Record Updates

Last Update Posted (Estimate)

June 26, 2015

Last Update Submitted That Met QC Criteria

June 25, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3216-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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