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Botox-A Injection to Improve Bladder Function in Early Spinal Cord Injury (#H-20344)

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00711087
First received: July 7, 2008
Last updated: March 4, 2010
Last verified: March 2010
  Purpose

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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Botulinum Toxin A Treatment of Detrusor External Sphincter Dyssynergia During Early Spinal Cord Injury (Protocol #H-20344)

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • A change in DLPP of 20cm H2O at Day 30 and Day 120 in the BTX-A injected group (Group 1) compared to the sham saline injected group (Group 2). [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]

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
Placebo Comparator: 2
Receiving placebo
Other: Saline injection
Group 2-sham saline injections on both Day 0 and Day 90.
Active Comparator: 1
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
Other Names:
  • BTX-A
  • Botulinum Toxin Type A

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or Females between ages of 18-50
  • Patient weighs over 111 pounds
  • Patient has documented Spinal Cord Injury T10 or above Thoracic Level by ASIA Score less than 8 weeks prior to the start of the study. Both complete and incomplete spinal cord injuries will be included in this study.
  • Ability to complete all study requirements including voiding diary and to attend all scheduled study visits, in the opinion of the investigator
  • Written informed consent has been obtained
  • Patient has negative pregnancy test result if female and of child-bearing potential
  • Written authorization for use and release of Health and Research Study Information has been obtained
  • Patient or family member is willing and able to perform clean intermittent catheterization for duration of this study

Exclusion Criteria:

  • Patient has received anticholinergic medication for the treatment of overactive bladder before randomization into the study
  • Patient has history or evidence of any pelvic or urological abnormalities, bladder or urethral surgery or disease, other than neurogenic bladder related to spinal cord injury, that may impact bladder function
  • Patient has significant stress urinary incontinence, determined by patient history, in the opinion of the investigator
  • Neurogenic detrusor overactivity (greater than 10cm elevation in pdet pressure) at baseline urodynamic screening (Day 0)
  • Patient found to have significant baseline renal pathology (e.g. hydronephrosis, stones, renal mass) at Day -7
  • Patient has a history of two or more treated urinary tract infections within 6 months of screening Day -7
  • Patient has urinary tract infection defined as a bacteriuria count of greater than 105/ml conjoint with leukocyturia greater than 5hpf at screening Day -7
  • Patient has asymptomatic urinary tract infection, defined as positive nitrites, leukocyte esterase and or blood on urine dipstick reagent strip at randomization Day 0
  • Patient has history of unexplained hematuria or unexplained hematuria if greater than 5 RBC's/hpf are present at screening Day -7
  • Patient has active genital infection, other than genital warts, either concurrently or within 4 weeks prior to screening Day -7
  • Patient has history of interstitial cystitis, in the opinion of the investigator
  • Patient has evidence of urethral obstruction, in the opinion of the investigator at screening Day -7 or randomization Day 0
  • Patient uses medications with anti-platelet or anti-coagulant effects (except Lovenox) within 10 days of randomization Day 0. Lovenox 30mg SQ every 12 hours is standard of care after SCI until 2-3 months post injury. Lovenox will be stopped 24 hours before and for 48 hours after each sphincter injection or bladder biopsy procedure.
  • Patient has hemophilia, or other clotting factor deficiencies or disorders that cause bleeding diathesis
  • Patient has previously been treated with any endovesical pharmacologic agent (e.g. capsaicin, resiniferatoxin)
  • Patient has had previous or current botulinum toxin therapy of any serotype for any condition
  • Patient has a known allergy or sensitivity to any components of the study medication, anesthetics or antibiotics to be used during the study
  • Any medical condition that may put the patient at increased risk with exposure to Botox® including diagnosed myasthenia gravis, Eaton-Lambert syndrome or amyotrophic lateral sclerosis
  • Females who are pregnant, nursing or planning a pregnancy during the study or females of child-bearing potential who are unable or unwilling to use a reliable form of contraception during the study
  • Current or previous participation in another therapeutic study within 30 days of screening Day -7
  • Any condition or situation which, in the investigator's opinion, puts the patient at significant risk, could confound the study results, or may interfere significantly with the patient's participation in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00711087

Locations
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Memorial Hermann Hospital/The Institute of Rehabilitation and Research
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
U.S. Department of Education
Investigators
Principal Investigator: Christopher P. Smith, MD Baylor College of Medicine
  More Information

Additional Information:
Publications:
Responsible Party: Christopher P. Smith, M.D., Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00711087     History of Changes
Other Study ID Numbers: H-20344
Study First Received: July 7, 2008
Last Updated: March 4, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Baylor College of Medicine:
Spinal Cord Injury
Bladder
Botulinum toxin (BOTOX-A
Detrusor External Sphincter Dyssynergia

Additional relevant MeSH terms:
Spinal Cord Injuries
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014