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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00711087
Recruitment Status : Terminated (Funds no longer available)
First Posted : July 8, 2008
Results First Posted : October 9, 2015
Last Update Posted : October 9, 2015
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Neurogenic Bladder Dysfunction Nos
Spinal Cord Injury
Interventions: Drug: BOTOX-A
Other: Saline injection

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
ARM 2 Patients in ARM 2 randomized to receive placebo (saline) injections on Days 0 and 90.
ARM 1 Patients in ARM 1 randomized to receive 100 units of BOTOX-A on Day 0 and Day 90

Participant Flow:   Overall Study
    ARM 2   ARM 1
STARTED   1   0 
COMPLETED   0   0 
Lost to Follow-up                1                0 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
ARM 2 Subjects randomized to receive placebo (saline) sham saline injections on Days 0 and 90.
ARM 1 Subjects randomized to receive 100 units of BOTOX-A injections on Days 0 and 90.
Total Total of all reporting groups

Baseline Measures
   ARM 2   ARM 1   Total 
Overall Participants Analyzed 
[Units: Participants]
 1   0   1 
[Units: Years]
Mean (Full Range)
 (36 to 36) 
 (36 to 36) 
[Units: Participants]
Female   0      0 
Male   1      1 
Region of Enrollment 
[Units: Participants]
United States   1      1 

  Outcome Measures

1.  Primary:   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 ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Christopher P. Smith, MD, MBA, MSS
Organization: Baylor College of Medicine
phone: 713-798-7498
e-mail: cps@bcm.edu


Responsible Party: Christopher Patrick Smith, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00711087     History of Changes
Other Study ID Numbers: H-20344
First Submitted: July 7, 2008
First Posted: July 8, 2008
Results First Submitted: September 11, 2015
Results First Posted: October 9, 2015
Last Update Posted: October 9, 2015