Multicenter Randomized Controlled Trial of Pelvic Floor Muscle Training with a Motion-based Digital Therapeutic Device versus Pelvic Floor Muscle Training Alone for Treatment of Stress-predominant Urinary Incontinence

Academic Article


  • Objective: To determine whether use of an intravaginal motion-based digital therapeutic device for pelvic floor muscle training (PFMT) was superior to PFMT alone in women with stress-predominant urinary incontinence (SUI). Methods: A multicenter, randomized-controlled trial was conducted where women with SUI or SUI-predominant mixed urinary incontinence were treated with either PFMT using the device (intervention group) or PFMT alone (control group). Primary outcomes, measured at 8 weeks, included change in Urinary Distress Inventory, short-version and improvement in the Patient Global Impression of Improvement, defined as “much better” or “very much better.” Participants also completed Pelvic Organ Prolapse and Colorectal-anal Distress Inventories, Pelvic-Floor-Impact Questionnaire and a 3-day bladder diary. Primary analysis used a modified intention-to-treat approach. Statistical analysis used Student t test and χ2 test. The trial was prematurely halted due to device technical considerations. Results: Seventy-seven women were randomized, and final analysis included 61 participants: 29 in intervention and 32 in control group. There was no statistical difference in Urinary Distress Inventory, short-version scores between the intervention (−13.7 ± 18.7) and the control group (−8.7 ± 21.8; P = 0.85), or in Patient Global Impression of Improvement (intervention 51.7% and control group 40.6%; P = 0.47). Pelvic Organ Prolapse and Colorectal-anal Distress Inventories and Pelvic-Floor-Impact Questionnaire scores improved significantly more in the intervention group than the control group (all P < 0.05). Median number of SUI episodes decreased from baseline to 8 weeks by −1.7 per-day [(−3)-0] in the intervention group and −0.7[(−1)-0] in the control group, (P = 0.047). Conclusions: In this prematurely terminated trial, there were no statistically significant differences in primary outcomes; however, PFMTwith this digital therapeutic device resulted in significantly fewer SUI episodes and greater improvement in symptom-specific quality of life outcomes. A larger powered trial is underway.
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    Author List

  • Weinstein MM; Collins S; Quiroz L; Anger JT; Paraiso MFR; DeLong J; Richter HE
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  • 28
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