Appendix Table 1. Open Label Study Measures.
Study Measure | Time Point* | |||||
---|---|---|---|---|---|---|
Baseline Open label |
2 week phone |
1 mo | 3 mo | 6 mo | 9 mo** | |
3-Day Voiding Diary | X | X | X | X | ||
Patient Perception of Bladder Condition (PPBC)¶ | X | X | X | X | ||
Patient Perception of Urgency Scale (PPUS)‡ | X | X | X | X | ||
Overactive Bladder Questionnaire (OAB-Q)§ | X | X | X | X | ||
Patient directed Dose Adjustment | X | X | X | X | ||
Adverse events (self-report) | X | X | X | X | X | X |
Post Void Residual (PVR) | X | X | X | |||
OAB Satisfaction (OAB-S)† | X | X | X | |||
Referral for Extended Evaluation (ExE)∥ | X | X | X | |||
Medication Distribution | X | X | X | X |
SV: Screening visit, RCT: Randomized controlled trial, mo: month
Or Early Termination
The Patient Perception of Bladder Condition is a single-item measure scored on a 6-point Likert scale, with higher scores indicating more severe bladder-related problems.13,14
The Patient Perception of Urgency Scale is a single-item measure scored on a 3-point Likert scale, with higher scores indicating greater urgency15
The Overactive Bladder Questionnaire is a 31-item instrument in which scores range from 0 to 100, with higher scores indicating more severe or bothersome overactive bladder symptoms.14
The Overactive Bladder Satisfaction is a validated disease-specific satisfaction measure our team adapted to assess participant satisfaction with treatment.19
Extended Evaluations were offered if the participant had two post void residuals (PVR) greater than 250cc on the same day or the participant reported lack of clinical improvement as captured on the OAB-S form or a safety issue was identified by the site PI.