| Literature DB >> 35278093 |
J Ekersund1, E Samuelsson1, L Lindholm1, M Sjöström2.
Abstract
INTRODUCTION AND HYPOTHESIS: A previous randomized controlled trial (RCT) demonstrated that the app Tät II, for self-management of mixed urinary incontinence (MUI) and urgency urinary incontinence (UUI), yielded significant, clinically relevant improvements in symptom severity and quality of life (QoL) compared with a control group. We aimed to assess the cost-effectiveness of Tät II.Entities:
Keywords: Health economics; Self-management; Urinary incontinence; e-health
Mesh:
Year: 2022 PMID: 35278093 PMCID: PMC9119896 DOI: 10.1007/s00192-022-05137-1
Source DB: PubMed Journal: Int Urogynecol J ISSN: 0937-3462 Impact factor: 1.932
Fig. 1Flowcharts of the randomized controlled trial (RCT) and the cost–utility analysis (CUA). The boxes represent the RCT and the green circles represent the CUA. The timeline shows the different time points (baseline and follow-ups) of the RCT where data used in the CUA were collected. The area above the red horizontal line represents the treatment app, and the area below the line represents the information app. The black arrow crossing the red line represents the information group getting access to the treatment app after the 3-month follow-up. The dashed line shows that the information group’s 3-month follow-up data were also used for the 1-year follow-up
Baseline characteristics of the study population (n = 122)
| Treatment group ( | Information group ( | ||
|---|---|---|---|
| General information | |||
| Age in years, mean (SD) | 58.9 (9.2) | 57.6 (9.9) | 0.44 |
| BMI in kg/m2, mean (SD) | 26.5 (3.6) | 26.0 (5.2) | 0.58 |
| University education ≥3 years, | 44 (73.3) | 34 (54.8) | 0.03 |
| Smoker, | 1 (1.7) | 2 (3.2) | ** |
| Gynecology | |||
| Nulliparity, | 8 (13.3) | 7 (11.3) | 0.73 |
| Postmenopausal ≥1 year, | 42 (70.0) | 46 (74.2) | 0.61 |
| Urinary incontinence | |||
| ICIQ-LUTSqola score, mean (SD) | 37.6 (8.3) | 38.1 (8.2) | 0.71 |
| ICIQ-UI SFb score, mean (SD) | 11.7 (3.5) | 11.5 (3.2) | 0.66 |
| ICIQ-UI SF score, severity category, | 0.97 | ||
| Slight, 1–5 points | 2 (3.3) | 1 (1.6) | |
| Moderate, 6–12 points | 35 (58.4) | 37 (59.7) | |
| Severe/very severe, 13–21 points | 23 (38.3) | 24 (38.7) | |
| Type of incontinence, | 0.49 | ||
| Mixed urinary incontinence | 45 (75.0) | 43 (69.4) | |
| Urgency urinary incontinence | 15 (25.0) | 19 (30.6) | |
| Daily users of incontinence aid, | 23 (38.3) | 26 (41.9) | 0.69 |
| Participants that run ≥1 extra laundry load per week due to UI, | 31 (51.7) | 32 (51.6) | 0.995 |
SD standard deviation, BMI body mass index, ICIQ-LUTSqol International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life
ICIQ-UI SF International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form
*p <0.05 was considered significant
**Not possible to analyze the statistical significance between groups owing to the small number of smokers in each group
aHigher values indicating greater impact on quality of life. Scoring scale: 19–76 points
bHigher values indicating greater severity of UI symptoms. Scoring scale: 0–21 points
Costs of the treatment group and information group, presented as annual costs per participant
| Price per unit | Units used | Costs | |||
|---|---|---|---|---|---|
| (€e) | Treatment group | Information group | Treatment group | Information group | |
| Assessmenta | 13.76 | 1 | 1 | 13.76 | 13.76 |
| Treatment deliveryb | 2.42 | 1 | . | 2.42 | 0 |
| Participant costs | |||||
| Participant’s timec for PFMT, mean (h) | 30.14 | 10.98 | 5.09 | 330.83 | 153.45 |
| Participant’s time for bladder training, mean (h) | 30.14 | 6.14 | 3.95 | 184.89 | 119.13 |
| Incontinence aidsd, mean ( | 0.41 | 138.2 | 203.3 | 56.8 | 83.6 |
| Extra laundry loads, mean ( | 0.68 | 34.4 | 53.0 | 23.4 | 36.1 |
| Participant’s time for laundry, mean (h) | 30.14 | 4.30 | 6.63 | 129.51 | 199.81 |
| Total cost | 741.62 | 605.82 | |||
PFMT pelvic floor muscle training
aAssessment cost includes the cost of time spent by the study coordinator and urotherapist on sending emails to and interviewing participants on the telephone respectively. These parts of the assessment were considered to be diagnosing urinary incontinence in a nontrial setting
bIncludes the cost of time spent on manually registering tailored advice for the treatment group, generated by a pre-prepared algorithm
cTime for PFMT, bladder training, and laundry is presented as hours per year. The time unit for PFMT and bladder training presented in the table is adjusted by the time the women spent on doing other things while exercising. The pricing of participants’ time was based on the average hourly wage for women with the same education level as our study population
dIncontinence aids, referring to pads bought from a pharmacy. Presented as mean use per year
eAll prices are presented in Euros (€), based on the 2017 year-end price
Fig. 2Total quality-adjusted life-years (QALY) change for the treatment app group and information app group. QALY change from baseline to 1-year follow-up. The timeline shows the three time points during the randomized controlled trial where data on participants’ quality of life were collected, using the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol). The y-axis shows the mean utility weights, which were calculated based on results from the ICIQ-LUTSqol. The utility weights were then used to calculate the area under the curve for each graph, which represents the total QALY change over the year for each study group
Incremental cost-effectiveness ratio (ICER) of the base case, and sensitivity analyses
| Total cost (€)a | QALY gainb | ∆ Cost (€) | ∆ QALY gain | ICER | |
|---|---|---|---|---|---|
| Base case | |||||
| Treatment group | 738.42 | 0.0152 | |||
| Information group | 605.82 | 0.0037 | |||
| Treatment group vs information group | 135.80 | 0.0115 | 11,770.52 | ||
| Sensitivity analysis | |||||
| Univariate: wages reduced for the retired proportion of the participants | |||||
| Treatment group | 641.13 | 0.0152 | |||
| Information group | 532.25 | 0.0037 | |||
| Treatment group vs information group | 108.88 | 0.0115 | 9,437.32 | ||
| Univariate: cost of incontinence aids halved | |||||
| Treatment group | 713.21 | 0.0152 | |||
| Information group | 564.02 | 0.0037 | |||
| Treatment group vs information group | 149.19 | 0.0115 | 12,930.70 | ||
| Univariate: time for PFMT and bladder training reduced by 50% | |||||
| Treatment group | 483.76 | 0.0152 | |||
| Information group | 469.53 | 0.0037 | |||
| Treatment group vs information group | 14.23 | 0.0115 | 1,233.37 | ||
| Univariate: time for PFMT and bladder training increased by 50% | |||||
| Treatment group | 999.48 | 0s.0152 | |||
| Information group | 742.10 | 0.0037 | |||
| Treatment group vs information group | 257.37 | 0.0115 | 22,307.67 | ||
| Univariate: time for PFMT and bladder training removed entirely | |||||
| Treatment group | 225.90 | 0.0152 | |||
| Information group | 333.24 | 0.0037 | |||
| Treatment group vs information group | −107.34 | 0.0115 | −9,303.78 | ||
| Multivariate: wages reduced for the retired, cost of incontinence aids halved, time for PFMT and bladder training reduced by 50% | |||||
| Treatment group | 395.02 | 0.0152 | |||
| Information group | 375.39 | 0.0037 | |||
| Treatment group vs information group | 19.63 | 0.0115 | 1,701.38 | ||
PFMT pelvic floor muscle training
aCosts presented in Euros (€) based on the 2017 year-end prices
bQALY gain over 1 year. Calculated as area under the curve