Clinical Trial Search

Primary: Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Episodes Per Week — 0.73 proportion of subjects — p=<0.0001

Primary: Treatment Response Defined as a 75% or Greater Change in Number of Average Weekly FI Episodes at Month 3 Follow-Up Compared to Baseline — 29; 28 Participants

Primary: Primary Effectiveness Endpoint — 75.9 percentage of treatment responders

Primary: Any Improvment in the Fecal Incontince Quality of Life Scale (FIQoLs) — 2.8; 3.3; 1.9; 2.5 score on a scale

Primary: Mean Fecal Incontinence and Constipation Assessment (FICA) Score — 8.1; 9.1; 6.5; 7.6 units on a scale

Primary: Number of Participants to Report a 50% or Greater Reduction in Weekly Fecal Incontinence (FI) Episodes — 17; 13 Participants — p=0.85

Primary: 7-day Bowel Diary, Number of Fecal Incontinence Episodes — 7.3; 7.9; 4.8; 4.1 Fecal incontinence episodes

Primary: Percentage of Responders — 69.1 percentage of treatment responders

Primary: Number of Treatment-Related Adverse Events — 0; 1; 5; 28 events

Primary: Frequency of FI Episodes — 79; 86 percentage of participants

Primary: Responder Rate in Number of Fecal Incontinence Episodes — 64.4 percentage of responders

Primary: Change in Anal Incontinence as Measured on the St. Mark's Score — 4.3; 4.5; 3.6; 4.1 units on a scale

Primary: Change From Baseline St. Mark's (Vaizey) Score — -5.5; -4.4; -4.5; -3.4 units on a scale — p=0.092

Primary: Adverse Events — 223; 7 Number of events

Primary: Fecal Incontinence Incidence From Baseline (Pre-treatment) Through 24 Months Post-treatment — 6.9; 3.0; 3.7; 3.7 Number of FI episodes/14 day period

Primary: Change From Baseline St. Mark's (Vaizey) Score — -2.8; -3.3; -4.3; -4.1 units on a scale

Primary: Percentage of Participants Who Are Responder50. — 71; 21 Participants

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

Primary: Percentage of Patients Considering the Treatment a Success After 5 Years — 81.7; 87.3; 31.2; 91.7 percentage of success

Primary: Count of Treatment Responders in the Intent to Treat (ITT) Cohort — 53 Participants

Primary: Amount of Urinary Leakage — 23.2; 22.3; 31.5; 11 grams

Primary: Cleveland Clinic Incontinence (CCI) Score — 4.2; 3.7; 1.2; -0.7 score on a scale — p=0.54

Primary: Clinical Remission — 4; 5 Participants — p=0.183

Primary: The Rate of Identification of Puborectalis During Ultrasound Scan — 8 Participants

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: Severity of Constipation Symptoms — 0.96; 0.97; 0.63; 0.67 score on a scale

Primary: Number of Patients With Anal Erosion Within 14 Days After Insertion of FMS — 5; 5 Participants

Primary: Adverse Events — 0 Participants

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

Primary: Percent Continent — 0; 0; 6; 0 percentage of participants