Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Baylor College of Medicine Department of Education |
---|---|
Information provided by: | Baylor College of Medicine |
ClinicalTrials.gov Identifier: | NCT00711087 |
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. Placebo patients are not expected to receive any direct benefits from participation in this study besides comprehensive urologic evaluation and follow-up. However, placebo patients as well as future untreated patients may benefit indirectly in the future depending on the long-term results of our study.
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.
Condition | Intervention | Phase |
---|---|---|
Detrusor External Sphincter Dyssynergia Spinal Cord Injury |
Drug: BOTOX-A Other: Saline injection |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Botulinum Toxin A Treatment of Detrusor External Sphincter Dyssynergia During Early Spinal Cord Injury (Protocol #H-20344) |
Estimated Enrollment: | 36 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | December 2017 |
Estimated Primary Completion Date: | December 2017 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
2: Placebo Comparator
Receiving placebo
|
Other: Saline injection
Group 2-sham saline injections on both Day 0 and Day 90.
|
1: Active Comparator
Receiving BOTOX-A
|
Drug: BOTOX-A
Group 1-100 units of BTX-A (Botox®, Allergan Inc., Irvine, CA) on Day 0 and 100 units of BTX-A on Day 90
|
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Wendi Gray, MS | wendig@bcm.edu | |
Contact: Linda C. Higgins, CCRP | 713-798-4079 | lhiggins@bcm.edu |
United States, Texas | |
Baylor College of Medicine | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Susan Kingston, LVN, CCRP 713-798-8514 slk@bcm.edu | |
Principal Investigator: Christopher P. Smith, MD | |
Sub-Investigator: George T. Somogyi, PhD | |
Memorial Hermann Hospital/The Institute of Rehabilitation and Research | Recruiting |
Houston, Texas, United States, 77030 | |
Sub-Investigator: Daniel Graves, PhD | |
Sub-Investigator: Juan Latorre, MD | |
Sub-Investigator: William H. Donovan, MD | |
Sub-Investigator: Karen Hart-Tudor, PhD |
Principal Investigator: | Christopher P. Smith, MD | Baylor College of Medicine |
Responsible Party: | Baylor College of Medicine ( Christopher P. Smith, M.D. ) |
Study ID Numbers: | H-20344 |
Study First Received: | July 7, 2008 |
Last Updated: | January 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00711087 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Spinal Cord Injury Bladder Botulinum toxin (BOTOX-A Detrusor External Sphincter Dyssynergia |
Spinal Cord Diseases Wounds and Injuries Central Nervous System Diseases Disorders of Environmental Origin Trauma, Nervous System Dyskinesias Spinal Cord Injuries |
Signs and Symptoms Botulinum Toxins Ataxia Neurologic Manifestations Peripheral Nervous System Agents Botulinum Toxin Type A |
Spinal Cord Diseases Anti-Dyskinesia Agents Physiological Effects of Drugs Nervous System Diseases Wounds and Injuries Central Nervous System Diseases Disorders of Environmental Origin Neuromuscular Agents Trauma, Nervous System Dyskinesias |
Pharmacologic Actions Spinal Cord Injuries Signs and Symptoms Botulinum Toxins Therapeutic Uses Ataxia Neurologic Manifestations Peripheral Nervous System Agents Botulinum Toxin Type A Central Nervous System Agents |