Clinical Trial Search

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: Urethral Opening Pressure (UOP) — 2.90411; -3.623431 cmH2O — p=0.07

Primary: Number of Subjects With Reduction in 24 Hour Pad Weight Test at 12 Months — 91 Participants — p=< 0.001

Primary: Number of Participants With a Change in Bladder Pressure — 0 participants

Primary: Bladder Storage — 278.5; 447.75; 580.5; 313.0 mLH2O

Primary: Change From Baseline in Opening Urethral Pressure (OUP) at Day 7 — 49.86; 49.86; 49.86; 47.92 centimeter of water (cmH2O) — p=0.4907

Primary: Urethral Sphincter Pressure — 50 cmH2O

Primary: Percent of Symptoms With Improvement of Leaks Reported — 14.4; 19.8; 18.2 Percent change in leaks

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

Primary: A 50% Reduction in Pad Test Weight — 12; 4 Participants

Primary: Primary Efficacy: Demonstrate the Efficacy of the ProACT Device in Reducing Incontinence as Measured by the 24-hour Pad Weight at 18 Months Compared to Baseline. A…

Primary: Movement of the Bladder — 23.1 pixels

Primary: Change in Urge Incontinence Episodes — 3.9 UUI

Primary: Voiding Efficiency — 87; 90 Percent voiding efficiency

Primary: Change of Stamey Grade From Baseline to 12 Months. — -1.17 units on a scale — p=<0.001

Primary: Change in Maximal Cystometric Capacity (mL) — 95; 473.50 milliliters (mL) — p=.005

Primary: Change in Quality of Life — 4.73; 3.95 score on a scale

Primary: Number of Continent Patients Post Prostatectomy — 37; 32 participants

Primary: Feasibility of Study Procedures Measured by Percentage of Participants Starting Intervention Who Complete the Study — 100; 90.4; 100 percentage of participants who…

Primary: Qmax Assessed Using Urodynamic Testing (Cystometry) — 14.0 mL/sec

Primary: Number of Urinary Urge Incontinent (UUI) Episodes Per Day - Randomized Portion — 1.64; 1.82; 1.44; 1.76 Number of UUI episodes/ Day — p=0.3773

Primary: Baseline Sexual Satisfaction Between Matched Female and Male Partners — 4.2; 4.8 score on a scale — p=.16

Primary: Rate of Product-related, Biopsy Procedure-related, and Injection Procedure-related Adverse Events — 0; 2; 0; 12 events

Primary: Change in OAB Symptoms Post Pubovaginal Sling Operation — 63; 21; 4 participants — p=0.001

Primary: Percent Change in Incontinence Episodes on Bladder Diary — 55; 51; 24 % change in episodes per week — p=.001

Primary: Primary Effectiveness Endpoint — 107; 50 participants

Primary: Day Urinary Frequency — 7.68; 10.95 number of diurnal micturitions per day

Primary: Number of Micturitions in 24 Hours

Primary: Change From Baseline in Frequency of Any Voiding or Incontinence Episodes Associated With At Least a Moderate Sensation of Urgency at 12 Weeks. — -1.06; -0.86 episodes…

Primary: Baseline Motility (Anorectal Sensation and Strength) Characteristics — 105; 34.4; 30; 77.9 mmHg