Clinical Trial Search

Primary: Number, Frequency and Severity of Product Related Adverse Events — 47; 63; 110; 5 Number of product related Adverse Events

Primary: Decrease in Nocturnal Enuresis — 16 Participants

Primary: Wet Nights — 2.4; 4.6 wet nights per week

Primary: Change in Number of Dry Nights When Using the Scheduled Awakening Protocol With the Lully Sleep Guardian — -0.67 difference in number of dry nights

Primary: Change in Nocturnal Polyuria Index — 41.7; 41.7; 34.5; 37.8 percentage of urine volume — p=0.3

Primary: Percentage of Wet Nights — -0.104790479; -0.099141959; -0.111602158 %change wet nights

Primary: Change in the Number of Wet Nights Between Baseline and Treatment Period II — 3.264; 1.451 wet nights — p=0.009

Primary: Overall Mean Change From Baseline in Mean Number of Nighttime Voids at Week 12 — -2.01 Number of nocturnal voids

Primary: Change in Mean Sleep Time Systolic Blood Pressure Dip Pre- vs Post-intervention — -0.4; 7.3; 3.9 percentage of daytime mean SBP — p=0.65

Primary: Change in Mean Number of Nocturic Episodes/Night — -1.3; -1.2 nocturic episodes per night

Primary: Change From Baseline in Aggregated Mean Number of Nocturnal Voids During 12 Weeks of Treatment — -1.06; -0.99; -0.89; -0.80 nocturnal voids

Primary: Change in Number of Nights Wet Per 2 Weeks — 11; 8.78; 8.75; 6.22 # nights wet over 2 weeks

Primary: The Pearson Correlation Coefficient Between Change From Baseline to Month 1 in Number of Nocturnal Voids and Change From Baseline to Month 1 in Nocturia Impact (NI)…

Primary: Change in Mean Number of Nocturic Episodes/Night — -1.3; -1.2 nocturic episodes per night

Primary: Change in Nocturia Episodes — 3.6; 3.3; 3.9; 3.6 average nightly voids — p=0.0017

Primary: Change From Baseline in Mean Number of Nocturnal Voids Averaged Over a 3-Month Period — -1; -1.21; -1.25; -1.47 nocturnal voids — p=0.0280

Primary: Number of Nocturic Episodes at the End of Treatment Compare to Prior to Treatment — -1.4; -1.5; -1.2 nocturic episodes per night

Primary: Change in # of Mean Nocturic Episodes Per Night — -1.4; -1.4; -1.6; -1.2 nocturic episodes per night

Primary: Part I: Change From Baseline in Mean Number of Nocturnal Voids at Week 4 — -0.86; -0.83; -1.00; -1.18 nocturnal voids — p=0.9303

Primary: Change in Nocturia Episodes — -1.2; -1.0 episodes

Primary: Dysfunctional Voiding Symptom Score — 8; 11 score on a scale

Primary: Number of Patients With Detrusor Leak Point Pressure (LPP) < 40 cm H2O — 23; 23; 28; 34 participants — p=1.00

Primary: Change From Baseline in Epworth Sleepiness Scale [ESS] — 9.03; 9.73 units on a scale

Primary: Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours — 2.93; 2.91 episodes per 24 hours

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

Primary: Change From Baseline in Mean Number of Nocturnal Voids Averaged Over a 3-Month Period — -1.06; -0.973; -0.591; -1.4 nocturnal voids — p=<0.0001

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

Primary: Number of Participants With a Decrease From Baseline ≥ 1 in the Society of Fetal Urology (SFU) Grade of Hydronephrosis — 2; 5; 3; 1 participants

Primary: Change From Baseline in Mean Number of Nocturnal Voids — -1.12; -1.30; -1.42; -1.47 nocturnal voids

Primary: Change in Urge Incontinence Episodes — 3.9 UUI