The Effect of Footwear Generated Biomechanical Manipulation on Symptoms of Stress Urinary Incontinence

Severity of SUI symptoms was measured using the six-item Urogenital Distress Inventory (UDI-6). The UDI-6 is a validated, patient-reported questionnaire which assesses the severity of symptoms of urinary incontinence. It includes questions evaluating the frequency of urination, incontinence/leakage, difficulty with complete bladder emptying, and pain. Responses on the UDI-6 are rated on a 5-point scale ranging from 0 ("No/Not present") to 4 ("Quite a bit"). Raw scores were summed, averaged, and multiplied by 25 to yield a final score scale ranging from 0-100. Higher scores are indicative of greater distress due to symptom severity. Results are summarized by study arm.

Quality of Life will be determined with the use of the UIQ-7 subscale component of the Pelvic Floor Impact Questionnaire-short form 7 (PFIQ-7) questionnaire. Specifically, the UIQ-7 questions within the PFIQ-7 are used to assess the impact of bladder or urine symptoms or conditions on a participant's daily function and activities, social health, or mental health over the prior 3 months. Participants provide responses for each question on 4-point scale ranging from 0 ("Not at all") to 3 ("Quite a bit"). Mean scores are averaged and multiplied by 100/3 to yield an overall possible score of 0-100, such that higher scores are indicative of a greater negative impact on quality of life from pelvic floor dysfunction. Scores are summarized by study arm using basic descriptive statistics.

PFM Activity was assessed during each visit by surface electromyography (sEMG). sEMG recording of the pelvic floor muscle activity was conducted via the use of Prometheus CTS 2000 EMG machine and vaginal sensor for optimal recording and was performed after pelvic examinations had been done to ensure there were no contraindications for the use of the probe. Neuromuscular electrical stimulation with 50 HZ was done via the use of the same intra-vaginal probe for the enhancement of the pelvic floor muscles. Electrical signals (microvolts) were measured during specific tasks and PFM average contraction, maximum contraction, and average rest results were calculated and reported in microvolts. Increased amplitude in waveforms, and corresponding result values, were associated with stronger muscle activation and decreased urinary incontinence. Average contraction results values are summarized by study arm using basic descriptive statistics.

PFM Activity was assessed during each visit by surface electromyography (sEMG). sEMG recording of the pelvic floor muscle activity was conducted via the use of Prometheus CTS 2000 EMG machine and vaginal sensor for optimal recording and was performed after pelvic examinations had been done to ensure there were no contraindications for the use of the probe. Neuromuscular electrical stimulation with 50 HZ was done via the use of the same intra-vaginal probe for the enhancement of the pelvic floor muscles. Electrical signals (microvolts) were measured during specific tasks and PFV average contraction, maximum contraction, and average rest results were calculated and reported in microvolts. Increased amplitude in waveforms, and corresponding result values, were associated with stronger muscle activation and decreased urinary incontinence. Maximum contraction results values are summarized by study arm using basic descriptive statistics.

PFM Activity was assessed during each visit by surface electromyography (sEMG). sEMG recording of the pelvic floor muscle activity was conducted via the use of Prometheus CTS 2000 EMG machine and vaginal sensor for optimal recording and was performed after pelvic examinations had been done to ensure there were no contraindications for the use of the probe. Neuromuscular electrical stimulation with 50 HZ was done via the use of the same intra-vaginal probe for the enhancement of the pelvic floor muscles. Electrical signals (microvolts) were measured during specific tasks and PFV average contraction, maximum contraction, and average rest results were calculated and reported in microvolts. Increased amplitude in waveforms, and corresponding result values, were associated with stronger muscle activation and decreased urinary incontinence. Average rest results values are summarized by study arm using basic descriptive statistics.

PFM Activity was assessed during each visit by surface electromyography (sEMG). sEMG recording of the pelvic floor muscle activity was conducted via the use of Prometheus CTS 2000 EMG machine and vaginal sensor for optimal recording and was performed after pelvic examinations had been done to ensure there were no contraindications for the use of the probe. Neuromuscular electrical stimulation with 50 HZ was done via the use of the same intra-vaginal probe for the enhancement of the pelvic floor muscles. Electrical signals (microvolts) were measured during specific tasks and PFV average contraction, maximum contraction, and average rest results were calculated and reported in microvolts. Increased amplitude in waveforms, and corresponding result values, were associated with stronger muscle activation and decreased urinary incontinence. Change From Average Contraction to Average Rest results values are summarized by study arm using basic descriptive statistics.

PFM Activity was assessed during each visit by surface electromyography (sEMG). sEMG recording of the pelvic floor muscle activity was conducted via the use of Prometheus CTS 2000 EMG machine and vaginal sensor for optimal recording and was performed after pelvic examinations had been done to ensure there were no contraindications for the use of the probe. Neuromuscular electrical stimulation with 50 HZ was done via the use of the same intra-vaginal probe for the enhancement of the pelvic floor muscles. Electrical signals (microvolts) were measured during specific tasks and PFV average contraction, maximum contraction, and average rest results were calculated and reported in microvolts. Increased amplitude in waveforms, and corresponding result values, were associated with stronger muscle activation and decreased urinary incontinence. Average Abdominal Contraction results values are summarized by study arm using basic descriptive statistics.

Adherence to FGBMM and PFPT was assessed based on self-reporting of in-person PFPT visits and in-person calibration visits (Dual Therapy study arm only) on an end of study questionnaire. Median number of visits is calculated and summarized by study arm.

Total costs associated with PFPT or PFPT+FGBMM will be summarized. Costs will include those associated with physical therapy, emergency department (ED) visits, medications, imaging studies, surgical procedures, physician visits related to symptoms of incontinence, and total physician visits. Mean costs will be summarized by study arm.

The gait assessment consists of the Spatio-temporal gait assessment including the following parameters: gait velocity, cadence, step length, gait cycle phases, step width, toe-in/out angle, center of pressure trajectory single limb support and limb symmetry measured by gait analysis. Results will be summarized by study arm.

Change in total healthcare facility utilization, including physical therapy, ED visits, pharmacological treatments, imaging studies, surgical procedures, physician visits related to symptoms of incontinence and total physician visits, as assessed by patient interview.