COST EFFECTIVENESS OF EMG BIOFEEDBACK ASSISTED PELVIC FLOOR MUSCLE THERAPY FOR WOMEN WITH OVERACTIVE BLADDER

Voorham J1, de Wachter S2, Bennink D1, Putter H1, Pelger R1, Lycklama à Nijeholt G1, Voorham - van der Zalm P1

Research Type

Clinical

Abstract Category

Rehabilitation

Abstract 28
Conservative Management
Scientific Podium Short Oral Session 3
On-Demand
Overactive Bladder Conservative Treatment Rehabilitation Urgency Urinary Incontinence Physiotherapy
1. Leiden University Medical Center, 2. University Hospital Antwerp
Presenter
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Abstract

Hypothesis / aims of study
The overactive bladder syndrome (OAB) is defined as urinary urgency (the primary symptom of OAB), usually accompanied by frequency and nocturia, with or without urgency urinary incontinence (UUI) by the International Continence Society (ICS). Within conservative management, behavioural treatment in combination with biofeedback-assisted pelvic floor muscle training (BAPFMT) is a first-line treatment option for OAB. 
Literature on comparative effectiveness indicates that behavioural treatments are either equivalent to or more effective than medications for reducing incontinence and overactive bladder (OAB) symptoms, without exposing patients to the typical side effects of medications. However, cost-effectiveness of pelvic floor physiotherapy and BAPFMT have a lack of evidence regarding long-term outcomes compared to other treatments. 
The aim of these analyses was to determine the Incremental Cost Effectiveness Ratio (ICER) of EMG Biofeedback Assisted Pelvic Floor Muscle Therapy (BAPFMT) with the Novuqare MAPLe in women with OAB (1,2).
Study design, materials and methods
Patients were randomly divided into an intervention group that received lifestyle instructions & toilet behaviour (L&T) and BAPFMT (8 sessions) or into a control group which received L&T (1 session)  first and BAPFMT (7 sessions) after 9 weeks (2). The outcomes of the King's Health Questionnaire (KHQ), the number of therapy-sessions and pad-use at baseline, after 9 weeks, 6 months and 1 year were taken as inputs. 
From the KHQ, Quality-Adjusted Life Years (QALYs) could be determined (3). As costs, €42,25 per therapy-session, €75 for MAPLe EMG probe and €0,24 per pad used per day were taken. 

A complete case analysis was done for two scenario’s; cost-effectiveness of adding BAPFMT to L&T and cost-effectiveness of L&T + BAPFMT and L&T + postponed BAPFMT compared to their baseline. For the first evaluation the outcomes at 9 weeks were extrapolated to 1 year. For the second evaluation all outcomes at baseline, 9 weeks, ½ year and 1 year were compared to the extrapolated baseline to 1 year. Within group t-test were perform to detect differences over time.
Results
The Flow diagram and number of complete cases used in both scenarios can be found in Figure 1. The utilities and pads/day as input for evaluating adding BAPFMT to L&T can be found in Figure 2a. For the L&T + BAPFMT group within group t-tests show that utility significantly increases and number of pads per day significantly decrease after 9 weeks. Figure 2b gives the resulting costs and QALYs used to calculate the ICERs. For the L&T group t-tests show that utility significantly increases after 9 weeks but the number of pads per day is slightly lower, but not significant. The ICER of adding BAPFMT to L&T is €29.207.

The utilities and pads/day as input for evaluating L&T + BAPFMT and L&T + postponed BAPFMT compared to their baseline can be found in Figure 2c. For the L&T + BAPFMT within group t-tests show that utility significantly increases and number of pads per day is lower, but not significant, in 1 year. For the L&T + postponed BAPFMT group t-tests show that utility significantly increases and the number of pads significantly decrease in 1 year.  Figure 2d shows the resulting costs and QALYs used to calculate the ICERs Compared to baseline, L&T + BAPFMT has an ICER of €22.204. Postponing BAPFMT for 9 weeks increases ICER to €37.089.
Interpretation of results
With a willingness to pay between €20.000-€30.000, L&T with BAPFMT with MAPLe is a cost-effective strategy for first-line therapy for women with OAB. And over a longer period it would even become cost-saving Since the costs are a function of time (pads/day), the benefit of (adding) BAPFMT increases over time. For the combined groups, L&T + (postponed) BAPFMT is cost-saving after less than 5 years. Larger RCTs are necessary to gain more insight in the cost-effectiveness, but these analyses look promising.
Concluding message
Lifestyle advice and Toilet behaviour in combination with Biofeedback Assisted Pelvic Floor Muscle Therapy (with MAPLe)  is a cost-effective strategy which becomes cost-saving over time and should be considered as a first-line therapy for women with OAB.
Figure 1 Figure 1: Flow diagram
Figure 2 Figure 2: Utility scores, pad use and calculated costs, QALYs and ICERs
References
  1. Voorham-van der Zalm PJ, Voorham JC, van den Bos TW, Ouwerkerk TJ, Putter H, Wasser MN. Reliability and differentiation of pelvic floor muscle electromyography measurements in healthy volunteers using a new device: the Multiple Array Probe Leiden (MAPLe). Neurourol Urodyn. 2013;32:341–348. https://doi.org/10.1002/nau.22311
  2. Voorham JC, De Wachter S, Van den Bos TW, Putter H, Lycklama à Nijeholt GA, Voorham - van der Zalm PJ. The effect of EMG biofeedback assisted pelvic floor muscle therapy on symptoms of the overactive bladder syndrome in women: A randomized controlled trial. Neurourology and Urodynamics. 2017;36:1796–1803. https://doi.org/10.1002/nau.23180
  3. Brazier J, Czoski-Murray C, Roberts J, Brown M, Symonds T, Kelleher C. Estimation of a preference-based index from a condition-specific measure: the King's Health Questionnaire. Med Decis Making. 2008 Jan-Feb;28(1):113-26. https://doi.org/10.1177/0272989X07301820
Disclosures
Funding Study was partially funded with and unrestricted grant from Novuqare Pelvic Health BV Clinical Trial Yes Registration Number Dutch CCMO register NL17997.058.08 RCT Yes Subjects Human Ethics Committee Leiden University Medical Center EC Helsinki Yes Informed Consent Yes
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