Interactive Pelvic Floor Muscle Training for Female Urinary Incontinence
IUGA Academy. Pulliam S. Jun 30, 2018; 212994; 351 Topic: Stress Incontinence
Dr. Samantha Pulliam
Dr. Samantha Pulliam

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Interactive pelvic floor muscle training for female urinary incontinence

Pulliam, S1;Rosenblatt, P2; Igleseas, R1

1: Renovia, Inc; 2: Harvard Medical School/Mt Auburn Hospital

Objective: To assess intervention effectiveness and patient satisfaction after treating female urinary incontinence (UI) with pelvic floor muscle training (PFMT) guided by the leva Incontinence System.

Methods: Pre- and perimenopausal women with mild-to-moderate stress or mixed UI underwent directional mechano-transductive interactive PFMT twice-daily for 6 weeks, with clinical supervision during one session on all weekdays. Representation of the motion of the vagina due to lift of the pelvic floor muscles was provided in real-time via Bluetooth to an application on the subject’s smart phone. Changes in subjective UI parameters and related quality-of-life were evaluated using validated incontinence questionnaires; objective measures included device-recorded maximum pelvic-floor muscle contraction strength, duration and pelvic floor angle, and UI episode frequency based on voiding diaries.

Results: Twenty-three women (42.0±10.7-years-old) participated, with a mean BMI was 26.01±4.01. As shown in the figure, the Urinary Incontinence Distress Inventory-6 score decreased 96% from 27.5±16.9 points at baseline to 1.1±2.9 points at 6 weeks (100 maximum possible; p<.0001). The Revised Urinary Incontinence Scale decreased 80% from 9.9±2.5 to 1.9±1.9 points (16 maximum; p<.0001). The Patient’s Global Impression of Severity score decreased 87% from 1.5±0.6 to 0.2±0.5 points (3 maximums: 0=no symptoms; p<.0001) at study terminus. The Incontinence Impact Questionnaire-7 score decreased 99% from 17.6±21.6 points to 0.2±1.0 points (100 points=maximal negative impact; p=.0009). Interactive PFMT increased maximum pelvic floor muscle contraction duration from 13±12 seconds to 187±46 seconds after 6 weeks (p<.0001). Median maximal contraction duration increased from 9 seconds at baseline to 203 seconds. Contractions achievable within 15 seconds increased from 5.9±2.0 at enrollment to 9.6±2.4 at 6 weeks (p<.0001). Maximum pelvic floor angle increased from 65.1±9.4° to 81.1±8.7° by 6 weeks (p<.0001). All subjective and objective benefits were apparent (p<.05) within 1 week of training, and sustained through study terminus. No procedure-/device-related adverse events occurred. Conclusion: Incontinence therapy guided by the leva Incontinence System rapidly, markedly, and significantly improves patient-reported UI symptom severity and related quality of life, and increases objective measures of pelvic floor muscle strength and function.


Work supported by industry: yes, by Renovia, Inc. A consultant, employee (part time or full time) or shareholder is among the authors (Renovia, Inc).

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