Trial Outcomes & Findings for Botox as a Treatment for Interstitial Cystitis in Women (NCT NCT00194610)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

3 months

Results posted on

2012-10-12

Participant Flow

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.

No pre-assignment criteria were used.

Participant milestones

Participant milestones
Measure	Saline Total 2 cc injected periurethrally	Botox 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
Overall Study STARTED	11	9
Overall Study COMPLETED	11	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Botox as a Treatment for Interstitial Cystitis in Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Saline n=11 Participants Total 2 cc injected periurethrally	Botox n=9 Participants 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 n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex/Gender, Customized Females	11 participants n=5 Participants	9 participants n=7 Participants	20 participants n=5 Participants
Sex/Gender, Customized Males	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Total number of subjects was based on clinical volume, and subjects were randomized into each of two arms.

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.

Outcome measures

Outcome measures
Measure	Placebo : Saline n=11 Participants Saline 2 cc total injected periurethrally	Experimental Intervention: Botox n=9 Participants 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.
Chronic Prostatitis Symptom Index (CPSI-F)	29.6 Total CPSI-F Standard Deviation 8.0	35.2 Total CPSI-F Standard Deviation 3.9

Adverse Events

Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Botox

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Claire Yang, MD

University of Washington

Phone: 206-744-6384

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place