In a recent study, stress urinary incontinence outcomes were improved in women utilizing pressure-mediated biofeedback vs pelvic floor muscle training alone.
Combining home-based pressure-mediated biofeedback (BF) with pelvic floor muscle training (PFMT) is more effective than PFMT alone for managing postpartum stress urinary incontinence (SUI) in women, according to a recent study published in JAMA Network Open.1
SUI is the most common pelvic floor disorder, leading to adverse impacts on physical and psychological health, quality of life, and socioeconomic burden. The condition has been reported in 25% to 45% of adult women, with the risk significantly increased by pregnancy and childbirth.2
Current guidelines recommend PFMT for at least 3 months, but physicians have wondered about potential adjunctive treatment methods that might prove more effective compared to PFMT alone.1 However, none of these methods, including BF, have received widespread acceptance.
To evaluate the efficacy of BF combined with PFMT vs PFMT alone in women with SUI, investigators conducted a multicenter randomized clinical trial. Participants included women aged at least 18 years with an SUI diagnosis within 12 weeks after delivery receiving regular postpartum checks between March 28, 2022, and October 13, 2023.
Women with urgency urinary incontinence alone, third- and fourth-degree perineal tears, diastasis recti abdominis and chronic pelvic pain, prior pelvic surgery, prepregnancy SUI, urogenital infections, malignant pelvic cancer, formal PFMT in the previous 5 years, or certain psychiatric or neurological disorders were excluded from the analysis.
Participants were randomized 1:1 to an intervention or control group. Those in the intervention group underwent PFMT with a home-based BF device while the control group completed PFMT at home. Demographic and outcome data was collected through electronic questionnaires.
Both groups underwent a training protocol involving 3 sets per day, with PFMT sessions observed by a researcher. Those in the intervention group reported any difficulties they experienced using the BF device.
The severity of urinary continence was reported as the primary outcome, measured based on the International Consultation on Incontinence Questionnaire–Urinary Incontinence Short Form (ICIQ-UI SF). ICIQ-UI SF scores under 5 indicated mild incontinence, 5 to 13 moderate, and over 13 severe.
Sections of the ICIQ-UI SF included frequency, amount, and impact of urine leakage. Cured SUI was indicated by a score of 0 after 3 months of treatment. The Incontinence Quality of Life Instrument was used to determine patients’ quality of life, while the Broome Pelvic Muscle Self-Efficacy Scale was used to determine self-efficacy.
There were 452 participants aged a median 34 years and with a median prepregnancy body mass index of 23.71 included in the analysis. Of participants, 223 received the intervention while 229 were controls, and baseline characteristics did not differ between these groups.
At baseline, similar ICIQ-UI SF were reported between groups. However, at the end of the 3-month period, the intervention group had a significantly higher difference in change from baseline score vs the control group, at 3 points vs 2 points, respectively. Reductions were 1 vs 0 points, respectively, for frequency, 0 vs 0, respectively, for amount, and 2 vs 1, respectively, for impact.
Significant improvements in mild and moderate SUI were observed in the intervention group vs the control group. However, there were no significant differences between groups in improvements of severe SUI.
Cured SUI was reported in 20.2% of the intervention group vs 8.7% of the control group. Both groups experienced significant improvements in quality of life after 3 months of treatment, but no significant differences in any of the 3 domains was observed between groups. Similar self-efficacy was also reported between groups.
These results indicated improved efficacy from a home-based BF training vs PFMT alone for treating postpartum SUI. Investigators concluded, “pressure-mediated BF devices enable clinicians to precisely monitor patients and reduce pressure on the health care system.”
References
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