Trial Outcomes & Findings for Study of Botulinum Toxin Type A (BOTOX®) to Treat Urinary Incontinence From Neurogenic Detrusor Overactivity in Belgium (NCT NCT02072928)

Results Overview

Anticholinergic drug use was collected the 9 months before the baseline Botox® treatment and the 9 months following the baseline Botox® treatment. Total anticholinergic drug use in the 9 months following the baseline Botox® treatment is noted.

Recruitment status

COMPLETED

Target enrollment

55 participants

Primary outcome timeframe

Baseline, 9 Months

Results posted on

2017-12-15

Participant Flow

Participant milestones

Participant milestones
Measure	BOTOX® Patients with incontinence from NDO due to spinal injury or MS prescribed BOTOX® (Botulinum toxin Type A) as standard of care in clinical practice.
Overall Study STARTED	55
Overall Study COMPLETED	55
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Botulinum Toxin Type A (BOTOX®) to Treat Urinary Incontinence From Neurogenic Detrusor Overactivity in Belgium

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BOTOX® n=55 Participants Patients with incontinence from NDO due to spinal injury or MS prescribed BOTOX® (Botulinum toxin Type A) as standard of care in clinical practice.
Age, Continuous	44.5 Years STANDARD_DEVIATION 16.0 • n=93 Participants
Sex: Female, Male Female	27 Participants n=93 Participants
Sex: Female, Male Male	28 Participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline, 9 Months

Population: Treatment responders for whom pharmacy data is available

Anticholinergic drug use was collected the 9 months before the baseline Botox® treatment and the 9 months following the baseline Botox® treatment. Total anticholinergic drug use in the 9 months following the baseline Botox® treatment is noted.

Outcome measures

Outcome measures
Measure	BOTOX® n=47 Participants Patients with incontinence from NDO due to spinal injury or MS prescribed BOTOX® (Botulinum toxin Type A) as standard of care in clinical practice.
Change From Baseline in Anticholinergic Drug Use Baseline	305.21 Doses of Anticholinergic Drugs Standard Error 36.94
Change From Baseline in Anticholinergic Drug Use 9 Months	199.77 Doses of Anticholinergic Drugs Standard Error 40.46

Adverse Events

BOTOX®

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	BOTOX® n=55 participants at risk Patients with incontinence from NDO due to spinal injury or MS prescribed BOTOX® (Botulinum toxin Type A) as standard of care in clinical practice.
Reproductive system and breast disorders Epididymitis	3.6% 1/28 All enrolled patients were used to assess adverse events and serious adverse events.
Renal and urinary disorders Pyelonephritis	1.8% 1/55 All enrolled patients were used to assess adverse events and serious adverse events.
Respiratory, thoracic and mediastinal disorders Progression of MS	1.8% 1/55 All enrolled patients were used to assess adverse events and serious adverse events.
Skin and subcutaneous tissue disorders Erysipelas	1.8% 1/55 All enrolled patients were used to assess adverse events and serious adverse events.

Other adverse events

Adverse event data not reported

Additional Information

Vice President Medical Affairs,

Allergan, Inc

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER