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Objective versus subjective outcome measures of biofeedback: Which really matter?
Amanda K. Berry, MSN, CRNP, Kristen Rudick, MSN CRNP, Meg Richter, BFA, Stephen A. Zderic, MD. The Children's Hospital of Philadelphia, Philadelphia, PA, USA.
Background: Clinical epidemiologic studies and experimental evidence from mouse models of voiding dysfunction suggest that once established, voiding dysfunction can become a lifelong condition if not treated correctly early on in life. Biofeedback is one component of a voiding retraining program to help children with voiding dysfunction. Our goal was to compare objective non-invasive urodynamic data obtained during office biofeedback sessions with patient reported voiding symptom scores and outcomes. Methods: Charts of 55 children referred in 2010 for pelvic floor muscle biofeedback therapy for urinary incontinence were retrospectively reviewed. Patients with any anatomic diagnoses such as spina bifida, tethered cord, or exstrophy were excluded. A total of 47 (86%) females and 8 males (14%) with a mean age of 8.2 years comprised the cohort. Uroflow curves, voided volumes and postvoid residuals were recorded at each visit and served as objective data. Volumes were normalized as a percentage of expected bladder capacity according to age. The patient reported symptom score (range 0 - 35) and patient reported outcome (improved, no change or worse) served as subjective measures of intervention. Results: The primary referral diagnoses were day and night wetting in 37(67%) and daytime incontinence in 18(33%) children. A history of urinary tract infection was noted in 32(64%) patients, and 25% were maintained on antibiotic prophylaxis during the study period. 29% were maintained on anticholinergic medication. Patients attended an average of 2.5 biofeedback sessions. Voided volumes at the first biofeedback session averaged 51% of expected bladder capacity and did not change significantly by the last biofeedback session. There was a negligible reduction in postvoid residual volumes after biofeedback. However, the patient reported symptom score decreased from 12.8 ± 5.6 to 8.0 ± 6.5 (p < 0.002), reflecting fewer daytime voiding symptoms. There was no significant change in the patient symptom score component for the night time wetting. Patient-reported outcomes at the final session of biofeedback were rated an improved in 26 (47%), no change in 15 (27%), worse in 3 (5%) patients and not rated in 11 patients (21%). Conclusions: Pelvic floor muscle biofeedback is associated with patient reported improvement in symptoms and reduction in voiding symptom score, however improvement is not correlated with objective parameters obtained during office visits for biofeedback. These findings are relevant because: i) coverage will eventually be eliminated for medical interventions that cannot offer outcomes analysis that demonstrates a benefit for the patient and ii) timely and efficient management of voiding dysfunction during childhood can reduce the risk for persistent voiding symptoms into adulthood.
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