Phase 3 N=76 Treatment

A Study to Assess the Long Term Effect, Safety and Metabolism of a Solifenacin Liquid Suspension in Participants 5 to 18 Years of Age With Neurogenic Detrusor Overactivity

Neurogenic Detrusor Overactivity

Bottom Line

View on ClinicalTrials.gov: NCT01565694 ↗

Enrolled (actual)

Serious AEs

9.2%

Results posted

May 2019

Primary outcome: Primary: Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC) — 57.2; 59.3 mL — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Solifenacin succinate (Drug)
Age: Pediatric · 5+ yrs
Sex: All
Sponsor: Astellas Pharma Europe B.V.
Primary completion: Apr 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC)	57.2; 59.3	<0.001 sig
SECONDARY Change From Baseline to Last Possible Titration Step in Maximum Cystometric Capacity	57.4	<0.001 sig
SECONDARY Change From Baseline in Bladder Compliance	9.1; 8.8	0.029 sig
SECONDARY Change From Baseline in Bladder Volume (mL) Until First Detrusor Contraction > 15 cmH2O as a Percentage of Expected Bladder Capacity (EBC)	23.10	<0.001 sig
SECONDARY Change From Baseline in Bladder Volume at 30 cmH2O Detrusor Pressure	61.8; 71.9	0.006 sig
SECONDARY Change From Baseline in Bladder Volume at 40 cmH2O Detrusor Pressure	67.0; 54.4	0.001 sig
SECONDARY Change From Baseline in Number of Overactive Detrusor Contractions (> 15 cmH2O) Until End of Bladder Filling	-2.3; -1.8	0.003 sig
SECONDARY Change From Baseline in Detrusor Pressure at the End of Bladder Filling	-9.2; -8.2	0.068
SECONDARY Change From Baseline in Average Catheterized Volume Per Catheterization	46.23; 48.86	<0.001 sig
SECONDARY Change From Baseline in Maximum Catheterized Volume	67.45; 69.63	<0.001 sig
SECONDARY Change From Baseline in Average First Morning Catheterized Volume	43.24; 44.21	<0.001 sig
SECONDARY Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours	-1.60; -1.62	<0.001 sig
SECONDARY Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days	1.06; 1.19	0.010 sig
SECONDARY Change From Baseline in Number of Dry (Incontinence-Free) Nights Per 7 Days	1.60; 1.64	<0.001 sig
SECONDARY Change From Baseline in Quality of Life [QoL] (PinQ Questionnaire Score)	-0.7; -0.7	0.568
SECONDARY Number of Participants With Adverse Events	51; 15; 0; 7; 0; 4	—

Summary

The purpose of this study was to investigate a medicine for the treatment of symptoms and complications of neurogenic detrusor overactivity (NDO) in children and adolescents.

Eligibility Criteria

Inclusion Criteria

Documented diagnosis of NDO, confirmed by urodynamics
Practicing clean intermittent catheterization (CIC)
Currently on treatment with an antimuscarinic drug

Exclusion Criteria

Known genitourinary condition (other than NDO) that may cause incontinence
Bladder augmentation surgery
Current Faecal impaction
Electro-stimulation therapy within 2 weeks prior to screening and at any time during the study
Subjects with the following gastro-intestinal problems: partial or complete obstruction, decreased motility like paralytic ileus, subjects at risk of gastric retention
Reflux grade 3 or 4
Current urinary tract infection (UTI)
Subject has severe renal impairment (glomerular filtration rate 9).
Subject has received intra-vesical botulinum toxin within 9 months prior to screening

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01565694). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.