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A Multi-Center Trial of Botox for Severe Urge Urinary Incontinence

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00345332
First Posted: June 28, 2006
Last Update Posted: July 11, 2017
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.
Information provided by (Responsible Party):
University of Rochester
Results First Submitted: April 4, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Urinary Incontinence
Interventions: Drug: Botox
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
  Description
Placebo Group 6 cc of saline was administered into the detrusor along the bladder base. We injected 0.5 ccs at each injection site.
Botox Group Botox (BTX) was administered into the detrusor along the bladder base. BTX was reconstituted in 6 ccs of preservative free saline according to manufacturers instructions. We injected 0.5 ccs at each injection site.

Participant Flow:   Overall Study
    Placebo Group   Botox Group
STARTED   11   20 
COMPLETED   11   20 
NOT COMPLETED   0   0 



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Placebo Group 6 cc of saline was administered into the detrusor along the bladder base. We injected 0.5 ccs at each injection site.
Botox Group BTX was administered into the detrusor along the bladder base. BTX was reconstituted in 6 ccs of preservative free saline according to manufacturers instructions. We injected 0.5 ccs at each injection site.
Total Total of all reporting groups

Baseline Measures
   Placebo Group   Botox Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 11   20   31 
Age 
[Units: Years]
Mean (Standard Deviation)
 67.45  (12.85)   65.15  (10.83)   65.97  (11.55) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      11 100.0%      20 100.0%      31 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   11   20   31 


  Outcome Measures
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1.  Primary:   Incontinent Episodes Per Day   [ Time Frame: week 13 ]

2.  Secondary:   Number of Incontinence Pads Used Per Day   [ Time Frame: week 13 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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: Division of Urogynecology
Organization: University of Rochester
phone: 585-273-3232
e-mail: amy_keller@urmc.rochester.edu


Publications of Results:

Responsible Party: University of Rochester
ClinicalTrials.gov Identifier: NCT00345332     History of Changes
Other Study ID Numbers: 12299
First Submitted: June 27, 2006
First Posted: June 28, 2006
Results First Submitted: April 4, 2016
Results First Posted: July 11, 2017
Last Update Posted: July 11, 2017