Clinical Trial Search

Primary: Mean Percentage of Pad Weight Gain (PWG) Change — 90.8; 98.5; 99.3; 89.3 Mean percentage of PWG change

Primary: International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF) — 11.1; 11.0; 7.0; 10.2 units on a scale — p=<0.001

Primary: Percentage of Responders for Pad Weight Gain or SUI Episodes — 69 percentage of subjects

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

Primary: Change From Baseline of Urine Leakage Measured by 1-hour Pad Test — 2.50; 0.05 g

Primary: Change in Pad Weight Gain — 2.67 grams/usage period

Primary: Percentage of Participants With Negative Cough Stress Test (CST) — 86.4; 83.1 percentage of participants

Primary: Primary Effectiveness Endpoint — 107; 50 participants

Primary: International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF) — 10.3; 10.4; 7.3; 6.9 units on a scale — p=0.27

Primary: Percentage of Patients Free of Stress Urinary Incontinence — 92.8 percentage of participants

Primary: Number of Participants With Negative Urinary Stress Test (no Leakage Noted on Examination During Cough or Valsalva Maneuvers at a Standardized Bladder Volume of 300 mL)…

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

Primary: Number of Participants With Subjectively Bothersome Stress Incontinence — 129; 126 Participants

Primary: "Much Better" or "Very Much Better" on PGI-I at 3 Months — 80; 72; 59 Participants — p=<0.0492

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

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: 24 Month Cumulative Success Rate Computed From Kaplan Meier Time-to-event Analysis (Reported as Percent Success). — 38; 47 % success at 24 months — p=0.01

Primary: Percentage of Participants With Response (Based on Stress IEF, or In-office Pad Weight Test, or 24-hour Pad Weight Test) at 12 Months — 82; 90 Percentage of subjects

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

Primary: Efficacy Assessed by Percent Reduction in Urinary Incontinence Episodes — 52.8; 7.9 percent reduction in leaks/day

Primary: Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8 — 2.9; 2.5; 2.6; 2.0 episodes

Primary: Treatment Success — 8; 9 Participants

Primary: Number of Participants With a ≥ 50% Reduction From Baseline in the Mean Number of Stress Incontinence Episodes Per Day at Week 12 — 94; 96; 87 Participants

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

Primary: Number of Participants With Treatment Failure Defined as Subsequent Treatment for Urinary Incontinence, Signs or Symptoms of Bothersome Urinary Incontinence — 39; 85…

Primary: Number of Participants With Stress Urinary Incontinence — 10; 13 Participants

Primary: Number of Participants That Experienced Biopsy Procedure-related Adverse Events — 1 participants

Primary: Number of Participants With Self-reported Mixed Urinary Incontinence Symptoms — 31; 34 Participants

Primary: Change From Baseline UDI Total Score — -138.8; -142.7; -137; -147.4 units on a scale