Trial Outcomes & Findings for Safety and Efficacy of botulinumA Toxin (BotoxA) for Treatment of Neurogenic Bladder of Parkinson's Disease (NCT NCT01421719)

Results Overview

Requirement for catheter because of urinary retention.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

zero to six months

Results posted on

2017-03-10

Participant Flow

Recruitment period extended between February 1, 2009 and September 2010. Stanford University Clinics represented location for enrollment and clinical trial.

Patients underwent screening in the clinic and were excluded per protocol prior to enrollment. Open label study.

Participant milestones

Participant milestones
Measure	Botulinum Toxin Treatment Injection of Botox into urinary bladder for neurogenic symptoms.
Overall Study STARTED	20
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Botulinum Toxin Treatment Injection of Botox into urinary bladder for neurogenic symptoms.
Overall Study Withdrawal by Subject	4

Baseline Characteristics

Safety and Efficacy of botulinumA Toxin (BotoxA) for Treatment of Neurogenic Bladder of Parkinson's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Botulinum Toxin Treatment n=20 Participants Injection of Botox into urinary bladder for neurogenic symptoms.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=99 Participants
Age, Categorical >=65 years	19 Participants n=99 Participants
Age, Continuous	70.95 years STANDARD_DEVIATION 8.22 • n=99 Participants
Sex: Female, Male Female	8 Participants n=99 Participants
Sex: Female, Male Male	12 Participants n=99 Participants
Region of Enrollment United States	20 participants n=99 Participants

PRIMARY outcome

Timeframe: zero to six months

Requirement for catheter because of urinary retention.

Outcome measures

Outcome measures
Measure	Urinary Leaks Per Day n=20 Participants 3-day voiding diary produced the clinical observation as an average per evaluation milestone.
Number of Patients Requiring Catheterization for Urinary Retention Secondary to Treatment.	0 participants

SECONDARY outcome

Timeframe: 6 months

Population: Per protocol. Quantified from 3-day voiding diary at baseline and each clinical evaluation to 6 months. Mean change in daily incontinence made up analysis.

Urinary incontinence 6 months after treatment (n=16). Data are included for participants who completed all diary entries and attended the Month 6 visit

Outcome measures

Outcome measures
Measure	Urinary Leaks Per Day n=16 Participants 3-day voiding diary produced the clinical observation as an average per evaluation milestone.
Number of Incontinence Episodes Per Day Baseline urinary incontinence	3.76 leaks/day Standard Deviation 2.57
Number of Incontinence Episodes Per Day Urinary incontinence 6 months after treatment	1.40 leaks/day Standard Deviation 1.43

Adverse Events

Botulinum Toxin Treatment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Botulinum Toxin Treatment n=20 participants at risk Injection of Botox into urinary bladder for neurogenic symptoms.
Renal and urinary disorders urinary tract infection	5.0% 1/20 • Number of events 1 • 0 to 6 months. Primary consideration of adverse events included pain, bleeding, infection and urinary retention.

Additional Information

Rodney U. Anderson, MD

Stanford University

Phone: 6504984240

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place