Clinical Trial Search

Primary: Number of Participants With Elevated Cytokines (Levels of Pro-inflammatory) — 20; 20; 16 Participants

Primary: Change in Overactive Bladder Symptoms (Based on OABqSF) — -19; -33.4 units on a scale — p=.07

Primary: Number of Participants With Study-related Adverse Events at 6 Months — 2; 1; 1; 1 participants

Primary: Mean Peak Detrusor Pressures — 58; 31 cm H2O

Primary: Daily Incontinence Episode Frequency (IEF) — 4.21; 3.33; 3.23; 4.40 episodes per day — p=0.11

Primary: Difference (Pre - Post) in Amplitude (Microvolts) of Urethral Sphincter Activity as Measured by Quantitative Concentric Needle EMG — -18; 10; 11; -15 microvolts — p=>0.05

Primary: Change From Baseline at Week 12 in Average Daily Number of Urgency Episodes — -1.13; -2.43; -3.37 Urgency episodes per day — p==0.1722

Primary: The Number of Participants Who Completed and Discontinued the Study — 11; 10; 1; 1 Participants — p=0.949

Primary: Change in Urge Urinary Incontinence (UUI) Episodes — -3.13; -3.15; -3.32; -3.25 Mean change in UUI episodes from baselin

Primary: Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 7 on Tolterodine 4 mg and Placebo — 1.15; 0.94 Percentage change — p=0.008

Primary: Voiding Efficiency — 32; 53; 43; 46 voided percentage — p=1

Primary: Number of Patients Requiring Catheterization for Urinary Retention Secondary to Treatment. — 0 participants

Primary: Response to Therapy — 15; 29 Participants

Primary: Change in the Number of UUI Episodes Over a 3-day Voiding Diary Pre- vs. Post-treatment. This Includes a Baseline Measure Pre-trial and a Pos-trial Measure in 12 Weeks…

Primary: 24-hour Voiding Frequency — 9.1; 9.5 voids per 24-hour day — p=.001

Primary: Change in Blood Oxygen Level Dependent (BOLD) Signals in the Brain After Treatment — 2.6; 2.6; 3.5; 2.6 BOLD Signal Change Derived T-Value — p=0.0012

Primary: Responder (Yes/no) — 23; 39; 36; 17 Participants

Primary: ICIQ-OAB Questionnaire — 5.5; 5.8 score on a scale

Primary: Cerebral Spinal Fluid Levels of Sanctura XR® at Day 10 Post-dose — NA Nanograms (ng) per milliliter (mL)

Primary: Change in Maximum Capacity at Cystoscopy Between Baseline and 6 Month Follow-up — -97.5; 64.1 mL — p=.016

Primary: Overactive Bladder Symptom Composite Score (OAB-SCS) at Baseline vs. Final Visit — 3.01; 2.56 score on a scale

Primary: Changes in the Mean BCI for Male From Baseline to Week 12 — 64.604; 61.339; 75.156; 60.513 Score on a scale — p=<0.001

Primary: Change in Urge Incontinence Episodes — 3.9 UUI

Primary: Number of Urge Urinary Incontinence (UUI) Episodes — -3.25; -3.89 UUI episodes

Primary: Changes in Brain Activity After Treatment Measured Using Functional MRI — 2.759234; 3.423569; 3.000987; 3.094914 BOLD fMRI T-Value — p=<0.05

Primary: Percentage of Participants Who Achieve a 100% Reduction in Urinary Incontinence Episodes — 32.0; 7.2 percentage of participants

Primary: Patient Perception of Bladder Condition Questionnaire — 3; 3 units on a scale

Primary: Average Number of Voids Per Day — NA; NA Average Number of Voids

Primary: Response to Urinary Incontinence as a Composite Measure of Efficacy of add-on Mirabegron — 12; 23 Participants

Primary: Change in Mean Number of Nocturnal Voids From Baseline — -1.63; -1.29 Voids — p=0.112