- This multicenter, single-blinded, randomized, controlled trial evaluated an intravaginal motion-based digital biofeedback device designed to guide pelvic floor muscle training (PFMT)
- For treatment of stress urinary incontinence, there was no difference in primary outcomes between 29 women who used the device and 32 women who performed PFMT conventionally
- However, use of the device was associated with significantly fewer episodes of incontinence and significantly greater improvement on certain symptom-specific quality of life questionnaires
- The trial had to be stopped early, and definitive results were published separately in a larger, fully powered randomized trial
Pelvic floor muscle training (PFMT, "Kegel exercises") is the first-line treatment for stress urinary incontinence (SUI), but cure rates are low. Many women find it difficult to distinguish between a "lift" and "squeeze," Valsalva maneuver, or other incorrect pelvic floor muscle motion. Electromyographic- or pressure-mediated biofeedback devices have not been shown to facilitate the proper performance of the exercises.
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A motion-based biofeedback device, the leva Pelvic Health System (Renovia, Inc.), has been FDA-cleared since November 2019. The device is inserted intravaginally and communicates wirelessly with an app downloaded to the patient's smartphone. Accelerometers (motion sensors) along the length of the device provide visual feedback to the patient about pelvic floor muscle/levator action.
Milena M. Weinstein, MD, co-director of the Center for Pelvic Floor Disorders in the Department of Obstetrics and Gynecology at Massachusetts General Hospital, and colleagues studied the digital therapeutic device in the first randomized, controlled trial of any motion-based digital therapeutic device for PFMT.
The manufacturer-sponsored trial was stopped early because technical difficulties arose with the device, but in Female Pelvic Medicine & Reconstructive Surgery the team reported promising results.
At seven sites, the researchers screened 95 women who had at least a three-month history of symptoms of SUI or stress-predominant mixed incontinence. Between October 2018 and September 2019, they enrolled 77 women, who were randomly assigned 1:1 either to the intervention group (PFMT using the study device) or the control group (PFMT performed conventionally). All patients received in-person training.
Women in the intervention group were instructed to perform the exercises twice daily, 2.5 minutes per session, for eight weeks. The regimen for the control group was three times daily, 10 repetitions per set, for eight weeks. All participants were asked to return at weeks 4 and 8.
At baseline, participants completed a battery of questionnaires and a three-day bladder diary. The questionnaires were repeated at both follow-up visits and the bladder diary was repeated at week 8. The 61 participants who completed at least one follow-up visit (29 in the intervention group, 32 in the control group) were included in the final analysis. Adequate power for the study required 93 participants per group.
The co-primary outcomes for the study were two patient-reported measures:
- Improvement from baseline to week 8 on the Patient Global Impression of Improvement questionnaire, defined as a response of "much better" or "very much better"—No significant difference between groups (52% vs. 41%; P=0.47)
- Difference between groups in improvement on the Urinary Distress Inventory, Short Form (UDI-6) from baseline to week 8—Not significant (−13.7 vs. −7.5; P=0.24)
Achievement of the minimum important difference (MID) on the full UDI has been defined as a reduction of 11 points. When the UDI-6 was converted to the UDI, both groups reached the MID by week 8, but only the intervention group reached it by week 4.
Other secondary outcomes were the changes from baseline to week 8 in:
- The median number of SUI episodes recorded in bladder diaries—Improved significantly more in the intervention group than in the control group
- Pelvic Organ Prolapse Distress Inventory score—Significantly improved only in the intervention group
- Colorectal–Anal Distress Inventory score—Significantly improved only in the intervention group
- Pelvic Floor Impact Questionnaire, Short Form score—Improved significantly more in the intervention group than the control group
- Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire score—Did not significantly improve in either group
The fact that only the intervention group reached MID by week 4 suggested the digital therapeutic device may help patients improve faster. A fully powered randomized, controlled trial subsequently validated that observation, and it linked use of the device to greater improvement of urinary symptom severity compared with unaided PFMT.
Learn more about the Center for Pelvic Floor Disorders
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