The purpose of this study is to evaluate the safety, efficacy, and PK of vibegron in pediatric participants with NDO who are regularly using CIC
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
85
Participants will be administered Vibegron orally, once daily (QD)
Children's Hospital of Orange County
Orange, California, United States
RECRUITINGNemours Childrens Health, Jacksonville
Jacksonville, Florida, United States
RECRUITINGWichita Urology Group
Wichita, Kansas, United States
Change from Baseline in maximum cystometric capacity (MCC) based on bladder filling urodynamics
Time frame: Baseline and at Week 32
Change from Baseline in MCC
Time frame: Baseline and at Week 20
Change from Baseline in number of overactive detrusor contractions until the end of bladder filling
Time frame: Baseline and at Weeks 20 and 32
Change from Baseline in detrusor pressure at the end of bladder filling
Time frame: Baseline and at Weeks 20 and 32
Change from Baseline in bladder filling volume until first involuntary/hyperactive detrusor contraction
Time frame: Baseline and at Weeks 20 and 32
Change from Baseline in bladder compliance (mL/cm H2O)
Bladder compliance is calculated by dividing the change in volume by the change in detrusor pressure during the filling of the bladder
Time frame: Baseline and at Weeks 20 and 32
Change from Baseline in average first morning catheterized volume
Time frame: Baseline and at Weeks 1, 4, 8, 20, 32, 48, and 52
Change from Baseline in average catheterized volume per catheterization
Time frame: Baseline and at Weeks 1, 4, 8, 20, 32, 48, and 52
Change from Baseline in average maximum catheterized volume per day
Time frame: Baseline and at Weeks 1, 4, 8, 20, 32, 48, and 52
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Childrens Hospital New Orleans
New Orleans, Louisiana, United States
RECRUITINGAlbany Medical College
Albany, New York, United States
RECRUITINGDuke University Medical Center
Durham, North Carolina, United States
RECRUITINGChange from Baseline in average maximum catheterized daytime volume
Time frame: Baseline and at Weeks 1, 4, 8, 20, 32, 48, and 52
Change from Baseline in average number of leakage episodes per day
Time frame: Baseline and at Weeks 1, 4, 8, 20, 32, 48, and 52
Change from Baseline in estimated number of dry (leakage-free) days/ 7 days
Time frame: Baseline and at Weeks 1, 4, 8, 20, 32, 48, and 52
Change from Baseline in Pediatric Incontinence Questionnaire (PIN-Q)
PIN-Q is a 20-item questionnaire addressing quality of life for participants with bladder disorders. Each question was answered on a scale from 0 (no, never) to 4 (all the time). The total score ranged from 0 to 80, with higher scores indicating more impact on the quality of life.
Time frame: Baseline and at Weeks 20, 32 and 52
Change from Baseline in Patient Global Impression of Severity (PGI-S) Scale
PGI-S is a 5 point scale that determines the bladder condition of a participant with 0 being really bad and 4 as really good. Higher score indicates better bladder condition.
Time frame: Baseline and at Weeks 20, 32 and 52
Change from Baseline in Clinical Global Impression of Change (CGI-C) Scale
The CGI-C scale is used to determine the degree of change in participant's overall bladder symptoms since the start of the study on Day 1. The scale will be filled by the investigator by ticking on any of the following options: very much improved, much improved, minimally improved, no change, minimally worse, much worse and very much worse.
Time frame: Baseline and at Weeks 20, 32 and 52