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

Urinary Incontinence Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02072928
• Other study ID #: MAF/AGN/NS/OAB/005
• Status: Completed
• Phase: N/A
• First received: February 25, 2014
• Last updated: May 12, 2017
• Start date: January 28, 2014
• Est. completion date: September 30, 2015

Study information

• Verified date: May 2017
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will evaluate the impact of BOTOX® treatment on anticholinergic drug use in patients with urinary incontinence from Neurogenic Detrusor Overactivity (NDO) due to spinal injury or Multiple Sclerosis (MS) who are prescribed BOTOX® as standard of care in clinical practice.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: September 30, 2015
• Est. primary completion date: September 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients prescribed BOTOX® for urine incontinence from NDO due to spinal injury or MS as standard of care in clinical practice in Belgium

• Previous treatment with anticholinergic drugs ineffective

• Last BOTOX® treatment =18 months.

Exclusion Criteria:

• Diagnosis of urinary incontinence less than 9 months.

• No anticholinergic drug use in the last 9 months.

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

Biological:
• botulinum toxin Type A
botulinum toxin Type A (BOTOX®) prescribed as standard of care in clinical practice.

Locations

Country	Name	City	State
Belgium	UZA	Edegem
Belgium	CHU de Liège	Esneux
Belgium	UZ Gent	Ghent
Belgium	Centre Hospitalier Regional de Huy	HUY
Belgium	UZ Leuven	Leuven
Belgium	Maria Ziekenhuis Noord-Limburg	Overpelt

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Anticholinergic Drug Use	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.	Baseline, 9 Months