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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 : September 5, 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
Enrollment 27
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Botox Upper Aspect Trigone Botox Periphery of Trigone
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 13 14
Completed 13 14
Not Completed 0 0
Arm/Group Title Botox Upper Aspect Trigone Botox Periphery of Trigone Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 13 14 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 14 participants 27 participants
48.38  (13.64) 46.5  (12.32) 47.41  (12.76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 14 participants 27 participants
Female
13
 100.0%
14
 100.0%
27
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 14 participants 27 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 14 participants 27 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%
1.Primary Outcome
Title The Primary Outcome Will be Assessing the Measurement of Subjective Patient Pain Using the O'Leary-Sant Symptom and Problem Indexes.
Hide Description The O'Leary-Sant is one questionnaire that assesses the severity of symptoms and the how much of a problem the symptoms cause for the patient and it provides two scores. The scores ranges for the symptoms is 0-20 and for how bothersome the symptoms are, the score range is 0-16. Higher scores for both denotes worse outcomes.
Time Frame 30 and 90 days post treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One participant was lost to follow-up in the experimental group and no data was collected at 30 days on one participant in the control group.
Arm/Group Title Botox Upper Aspect Trigone Botox Periphery of Trigone
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 12 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
Symptoms @ 30 days Number Analyzed 12 participants 13 participants
10.92  (3.15) 10.85  (4.18)
Bother @ 30 days Number Analyzed 12 participants 13 participants
9.75  (4.00) 9.92  (4.61)
Symptoms @ 90 days Number Analyzed 12 participants 14 participants
10.75  (3.62) 12.00  (4.54)
Bother @ 90 days Number Analyzed 12 participants 14 participants
10.17  (3.16) 10.29  (4.07)
2.Primary Outcome
Title The Primary Outcome Will be Assessing the Measurement of Subjective Patient Pain Using the Pelvic Pain and Urinary Urgency Frequency (PUF) Questionnaire
Hide Description The PUF questionnaire evaluates symptoms of pain and how much they bother the patient. Two score are given and added together to produce a total score. The score range for symptoms is 0-28 and the range for bother is 0-16. Higher scores denotes worse outcomes.
Time Frame 30 and 90 days post-treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One participant from the experimental group was lost to follow-up. Data was not collected at 30 days for bother and symptom for one participant in the control group.
Arm/Group Title Botox Upper Aspect Trigone Botox Periphery of Trigone
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 12 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
Symptoms @ 30 days Number Analyzed 12 participants 13 participants
13.83  (4.90) 12.31  (4.71)
Bother @ 30 days Number Analyzed 12 participants 13 participants
7.33  (2.77) 7.31  (3.17)
Symptoms @ 90 days Number Analyzed 12 participants 14 participants
13.33  (4.75) 13.21  (4.42)
Bother @ 90 days Number Analyzed 12 participants 14 participants
7.25  (2.83) 7.5  (2.77)
3.Secondary Outcome
Title Change in Patient Performance in Uroflowmetry.
Hide Description Uroflowmetry is a test that measures the volume of urine released from the body, the speed with which it is released, and how long the release takes.
Time Frame 30 days and 90 days post treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No data was collected for two participants in the experimental group and one participant in the control group at 30 days. No data was collected for one participant in the experimental group at 90 days.
Arm/Group Title Botox Upper Aspect Trigone Botox Periphery of Trigone
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 12 14
Mean (Standard Deviation)
Unit of Measure: ml/s
@ 30 days Number Analyzed 11 participants 13 participants
11.82  (5.64) 9.5  (7.83)
@ 90 days Number Analyzed 12 participants 14 participants
12.17  (7366) 15.5  (11.89)
4.Other Pre-specified Outcome
Title Secondary Outcomes Will be Assessing Change in Patient Performance in Post Void Residuals.
Hide Description [Not Specified]
Time Frame 30 days and 90 days post treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data was not collected on one participant in the experimental group at 30 and 90 days post treatment. Data was not collected on two individuals at 30 days post treatment in the control group.
Arm/Group Title Botox Upper Aspect Trigone Botox Periphery of Trigone
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 12 14
Mean (Standard Deviation)
Unit of Measure: mL
@ 30 days Number Analyzed 12 participants 12 participants
27.17  (37.06) 35.33  (48.00)
@ 90 days Number Analyzed 12 participants 14 participants
38.92  (48.10) 60.64  (71.38)
Time Frame baseline, up to 4 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Botox Upper Aspect Trigone Botox Periphery of Trigone
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Botox Upper Aspect Trigone Botox Periphery of Trigone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/14 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Botox Upper Aspect Trigone Botox Periphery of Trigone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Botox Upper Aspect Trigone Botox Periphery of Trigone
Affected / at Risk (%) Affected / at Risk (%)
Total   4/13 (30.77%)   7/14 (50.00%) 
Renal and urinary disorders     
Painful Voiding *  0/13 (0.00%)  1/14 (7.14%) 
Urethral Edema *  1/13 (7.69%)  0/14 (0.00%) 
Urgency *  1/13 (7.69%)  2/14 (14.29%) 
Urinary Tract Infection *  2/13 (15.38%)  2/14 (14.29%) 
Retention *  0/13 (0.00%)  2/14 (14.29%) 
*
Indicates events were collected by non-systematic assessment
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
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: September 5, 2018