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Trial record 14 of 141 for:    Cystitis, Interstitial

Intravesicular Onabotulinumtoxin A in Interstitial Cystitis

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ClinicalTrials.gov Identifier: NCT02297100
Recruitment Status : Completed
First Posted : November 21, 2014
Results First Posted : May 22, 2018
Last Update Posted : May 22, 2018
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Interstitial Cystitis
Interventions: Drug: Onabotulinumtoxin A
Procedure: injections upper aspect of trigone of urinary bladder
Procedure: injections on posterior bladder wall excluding the trigone

  Participant Flow

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
No text entered.

Reporting Groups
  Description
Botox Upper Aspect Trigone

Subjects in the experimental cohort will receive a one time dose of 100 units of Onabotulinumtoxin A diluted in 10 mL of preservative free normal saline and injected in 1.0 mL boluses in a set pattern across the upper aspect of the trigone of the urinary bladder.

Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections

injections upper aspect of trigone of urinary bladder: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder.

Botox Periphery of Trigone

Each group will receive a total of 100 units of botox spread out among 10 separate injections. Subjects in the control group will have 10 injections made about the periphery of the trigone. The control cohort will receive a one time dose of Onabotulinumtoxin A using the same dilution and number of boluses, but boluses will be administered at random sites on the posterior bladder wall (excluding the trigone).

Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections

injections on posterior bladder wall excluding the trigone: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder.


Participant Flow:   Overall Study
    Botox Upper Aspect Trigone   Botox Periphery of Trigone
STARTED   13   14 
COMPLETED   13   14 
NOT COMPLETED   0   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.
No text entered.

Reporting Groups
  Description
Botox Upper Aspect Trigone

Subjects in the experimental cohort will receive a one time dose of 100 units of Onabotulinumtoxin A diluted in 10 mL of preservative free normal saline and injected in 1.0 mL boluses in a set pattern across the upper aspect of the trigone of the urinary bladder.

Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections

injections upper aspect of trigone of urinary bladder: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder.

Botox Periphery of Trigone

Each group will receive a total of 100 units of botox spread out among 10 separate injections. Subjects in the control group will have 10 injections made about the periphery of the trigone. The control cohort will receive a one time dose of Onabotulinumtoxin A using the same dilution and number of boluses, but boluses will be administered at random sites on the posterior bladder wall (excluding the trigone).

Onabotulinumtoxin A: 100 units of botox spread out among 10 separate injections

injections on posterior bladder wall excluding the trigone: We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder.

Total Total of all reporting groups

Baseline Measures
   Botox Upper Aspect Trigone   Botox Periphery of Trigone   Total 
Overall Participants Analyzed 
[Units: Participants]
 13   14   27 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.38  (13.64)   46.5  (12.32)   47.41  (12.76) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      13 100.0%      14 100.0%      27 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      1   7.1%      1   3.7% 
Not Hispanic or Latino      13 100.0%      13  92.9%      26  96.3% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      1   7.1%      1   3.7% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1   7.7%      0   0.0%      1   3.7% 
White      12  92.3%      13  92.9%      25  92.6% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures

1.  Primary:   The Primary Outcome Will be Assessing the Measurement of Subjective Patient Pain Using the O'Leary-Sant Symptom and Problem Indexes.   [ Time Frame: 30 and 90 days post treatment ]

2.  Primary:   The Primary Outcome Will be Assessing the Measurement of Subjective Patient Pain Using the Pelvic Pain and Urinary Urgency Frequency (PUF) Questionnaire   [ Time Frame: 30 and 90 days post-treatment ]

3.  Secondary:   Change in Patient Performance in Uroflowmetry.   [ Time Frame: 30 days and 90 days post treatment ]

4.  Other Pre-specified:   Secondary Outcomes Will be Assessing Change in Patient Performance in Post Void Residuals.   [ Time Frame: 30 days and 90 days post treatment ]


  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
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Robert Evans
Organization: Wake Forest University Health Sciences
phone: 336-713-0320
e-mail: revans@wakehealth.edu



Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02297100     History of Changes
Other Study ID Numbers: IRB00026734
First Submitted: September 30, 2014
First Posted: November 21, 2014
Results First Submitted: March 21, 2018
Results First Posted: May 22, 2018
Last Update Posted: May 22, 2018