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Trial record 63 of 158 for:    interstitial cystitis

Botox as a Treatment for Interstitial Cystitis in Women

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: NCT00194610
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : October 12, 2012
Last Update Posted : October 12, 2012
Sponsor:
Collaborator:
Paul G. Allen Family Foundation
Information provided by (Responsible Party):
University of Washington

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Painful Bladder Syndrome
Interstitial Cystitis
Interventions Drug: Botox
Other: normal saline
Enrollment 20
Recruitment Details 20 subjects were recruited to a double blind study comparing Botulinum toxin A to normal saline. Each subject received either 50 units of Botulinum Toxin A or normal saline in the periurethral tissue in the Urology Clinic of the University of Washington.
Pre-assignment Details No pre-assignment criteria were used.
Arm/Group Title Saline Botox
Hide Arm/Group Description Total 2 cc injected periurethrally Botox 25 IU injected bilaterally periurethrally for a total of 50 IU. Possible but not mandatory was two more injections of 25 IU in each of two trigger points
Period Title: Overall Study
Started 11 9
Completed 11 9
Not Completed 0 0
Arm/Group Title Saline Botox Total
Hide Arm/Group Description Total 2 cc injected periurethrally Botox 25 IU injected bilaterally periurethrally for a total of 50 IU. Possible but not mandatory was two more injections of 25 IU in each of two trigger points Total of all reporting groups
Overall Number of Baseline Participants 11 9 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 9 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
 100.0%
9
 100.0%
20
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 11 participants 9 participants 20 participants
Females 11 9 20
Males 0 0 0
1.Primary Outcome
Title Chronic Prostatitis Symptom Index (CPSI-F)
Hide Description CPSI-F was adapted from the CPSI, in order to document the location of pain, with working pertinent to female anatomy. The CPSI-F was scored on a range of 0-83 (0-61 in the pain domain, 0-10 in the urination domain, 0-6 in the impact of symptoms domain, and 0-6 in the quality of life domain), with higher scores denoting worse symptoms.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Total number of subjects was based on clinical volume, and subjects were randomized into each of two arms.
Arm/Group Title Placebo : Saline Experimental Intervention: Botox
Hide Arm/Group Description:
Saline 2 cc total injected periurethrally
Botulinum toxin 25 IU injected bilaterally periurethrally for a total of 50 IU. Possible, but not mandatory, injections of 25 IU in each of 2 trigger points.
Overall Number of Participants Analyzed 11 9
Mean (Standard Deviation)
Unit of Measure: Total CPSI-F
29.6  (8.0) 35.2  (3.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Saline Botox
Hide Arm/Group Description Total 2 cc injected periurethrally Botox 25 IU injected bilaterally periurethrally for a total of 50 IU. Possible but not mandatory was two more injections of 25 IU in each of two trigger points
All-Cause Mortality
Saline Botox
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Saline Botox
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Saline Botox
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/9 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Claire Yang, MD
Organization: University of Washington
Phone: 206-744-6384
EMail: cyang@uw.edu
Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT00194610     History of Changes
Other Study ID Numbers: 25398-D
First Submitted: September 13, 2005
First Posted: September 19, 2005
Results First Submitted: December 29, 2010
Results First Posted: October 12, 2012
Last Update Posted: October 12, 2012