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

• Register: ClinicalTrials.gov
• Last refreshed on: 18 January 2021
• Main ID: NCT00711087
• Date of registration: 07/07/2008
• Prospective Registration: No
• Primary sponsor: Baylor College of Medicine
• Public title: Botox-A Injection to Improve Bladder Function in Early Spinal Cord Injury (#H-20344)
• Scientific title: Botulinum Toxin A Treatment of Detrusor External Sphincter Dyssynergia During Early Spinal Cord Injury (Protocol #H-20344)
• Date of first enrolment: July 2007
• Target sample size: 1
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00711087
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Christopher P. Smith, MD
• Affiliation: Baylor College of Medicine

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Neurogenic Bladder Dysfunction Nos

Spinal Cord Injury

Intervention(s)

Drug: BOTOX-A

Other: Saline injection

Primary Outcome(s)

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]

Secondary ID(s)

H-20344

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

U.S. Department of Education

Results

• Results available: Yes
• Date Posted: 09/10/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00711087