Botox-A Injection to Improve Bladder Function in Early Spinal Cord Injury (#H-20344)
Status:
Terminated
Trial end date:
2010-02-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to see what the effect of Botox has on bladder function for
those who have recently suffered spinal cord injury. We also will study bladder tissue levels
of NGF (nerve growth factor) that can tell us how the nerves to the bladder are healing after
injury.
Consenting male and female cervical and high thoracic (T10 and above) SCI patients will be
identified within the first 6-7 weeks after SCI and randomized to two external urethral
sphincter injection groups. Each group will be injected within 8 weeks after SCI (Day 0) and
3 months later (Day 90). The injection paradigm will consist of: Group 1-100 units of BTX-A
(Botox®, Allergan Inc., Irvine, CA) on Day 0 and 100 units of BTX-A on Day 90; Group 2-sham
saline injections on both Day 0 and Day 90. Injections will be performed under local
anesthesia using standard flexible cystoscopic equipment.
Use of placebo is justified because: 1. there have been documentation of nerve
desensitization with dry needling (i.e. acupuncture) and wet needling (i.e.
saline)--therefore, to truly demonstrate benefit of Botox over just the needle insertion into
the sphincter muscle or injection of the diluent saline, a sham saline injection group is
included, 2. the injection procedure itself is minimally invasive and not expected to result
in any complications.
Subjects who qualify and have signed the informed consent document will be randomized into
two groups, those receiving the BTX-A and those receiving placebo. Blinding will be performed
by the TIRR pharmacy department who will provide Botox and placebo in identical syringes so
that the treating staff will be blinded. Pharmacists will ensure patients receive the same
agent at the time of the second injection. Unblinding will occur at the end of the study or
if complications necessitate breaking of the code. Both groups will undergo urodynamic
testing to document before and after treatment data. Bladder biopsies will be taken prior to
treatment in both groups that will be analyzed for nerve growth factor. Three day voiding
diaries will be kept and reviewed with the study coordinator at the follow up visits. Quality
of life questionnaires will be completed at each follow up visit. The treatments will take
place on Day 0 and Day 90. Follow up visits will occur at Day 120, 16 month, and 28 months.
Phase:
Phase 2
Details
Lead Sponsor:
Baylor College of Medicine
Collaborator:
U.S. Department of Education
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A incobotulinumtoxinA onabotulinumtoxinA