Overview of Secondary Measures Sample Clauses

Overview of Secondary Measures. Mean change from study Baseline (assessed at Screening) or from treatment cycle baseline (assessed at Retreatment Assessment Visit) to post-treatment timepoints (timepoints listed in Table 4 and Table 5): • Bladder diary measures: • weekly number of UI episodes • daily urinary frequency (total, spontaneous void only, CIC only) • 24-hour voided volume (total, spontaneous void only, CIC only) • volume per void (total, spontaneous void only, CIC only). • Urodynamic filling cystometry measures: • maximum cystometric capacity (MCC) • maximum detrusor pressure (MDP) during storage • volume at first involuntary detrusor contraction (Vol@1stIDC) (subjects without a post-treatment IDC will have their Vol@1stIDC imputed from their MCC) • maximum detrusor pressure at first involuntary detrusor contraction (PdetMax@1stIDC) • end fill pressure (EFP) • detrusor compliance (DC). • Patient-reported outcome questionnaires: • incontinence quality of life (I-QoL) total summary score • EuroQol 5-dimension 5-level (EQ-5D-5L) • modified patient global impression - improvement (mPGI-I) score (to be assessed at each timepoint without comparison to baseline). Proportion of subjects at post-treatment timepoints following the first and subsequent treatments with: • no episodes of UI (x.x. xxxxxxxxxx is achieved) • UI response at several levels (i.e. ≥30% improvement, ≥50% improvement, ≥75% improvement etc.) • no IDCs on urodynamic assessment (i.e. urodynamic cure is achieved). Duration of effect following the first and subsequent treatments measured by: • time to request retreatment • time to eligibility for retreatment • time between treatments.
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