In brief
Cost-utility of implantable tibial neuromodulation (Revi) versus conservative therapy for urgency urinary incontinence in adults: a US payer perspective. is a nursing research record that should be interpreted using the available source metadata.
What this article is about
Quick Answer
Cost-utility of implantable tibial neuromodulation (Revi) versus conservative therapy for urgency urinary incontinence in adults: a US payer perspective. is a nursing research record that should be interpreted using the available source metadata.
Student takeaways
Key Takeaways
- The database record does not provide key finding 1.
- The database record does not provide key finding 2.
- The database record does not provide key finding 3.
- The database record does not provide key finding 4.
- The database record does not provide key finding 5.
Student summary
Why This Research Matters
This article, published in the Journal of Medical Economics on January 1, 2026 (DOI: 10.1080/13696998.2026.2655592), investigates whether a new medical device called Implantable Tibial Neuromodulation (ITNM) with an external wearable battery, known as the Revi System, is cost-effective for treating Urgency Urinary Incontinence (UUI). UUI is defined by sudden, strong urges to urinate that are difficult to control and can lead to accidents. This condition significantly impacts quality of life and daily activities for adults. The study specifically compares ITNM with conservative treatments like behavioral therapy and medication from the perspective of healthcare payers (such as insurance companies or government programs). For nursing students, this article is valuable because it demonstrates how economic models are used in health policy decisions to evaluate new therapies. It highlights that these models rely on assumptions about disease progression, treatment effectiveness, costs, and patient preferences.
The research uses a complex computer modeling technique called a Markov model. This type of model simulates patient outcomes over time by placing them into different 'health states' (e.g., responder to treatment, non-responder) and allowing transitions between these states based on probabilities derived from existing clinical data. In this study, the ITNM clinical parameters were primarily sourced from the OASIS pivotal trial, which involved 150 participants. The model's uncertainty was addressed using Monte Carlo simulations (20,000 runs). Health states in the model included responder and non-responder status for UUI treatment, with pathways for rescue interventions if initial treatments failed or were ineffective (such as onabotulinumtoxinA injections, sacral neuromodulation, or percutaneous tibial nerve stimulation). The model also incorporated downstream event modules to account for potential complications or comorbidities associated with UUI and its treatment. These included risks of falls, urinary tract infections, incontinence-associated dermatitis (skin irritation), depression, cognitive decline/dementia, and even nursing-home entry.
The study's main findings are based on a 3-year simulation period from the US payer perspective, considering only direct medical costs. The results indicate that ITNM with Revi was both more effective and less costly than conservative treatments over this three-year timeframe. Specifically: 1. Mean total healthcare costs were $39,308 for patients receiving ITNM versus $43,737 for those on conservative therapy, resulting in a net cost saving of -$4,428 with ITNM. 2. In terms of quality-adjusted life-years (QALYs), which measure both the quantity and quality of life gained, patients using ITNM achieved an average of 2.188 QALYs over three years, compared to 1.940 QALYs for those on conservative treatments. This represents a gain of +0.249 additional QALYs with ITNM. 3. The incremental cost-effectiveness ratio (ICER) was calculated as -$17,818 per QALY gained. A negative ICER means that the intervention is not only more effective but also less costly than the alternative; this is termed 'dominant' in economic evaluations and indicates strong value. 4. The incremental net monetary benefit (INMB) at a willingness-to-pay threshold of $40,000 per QALY was calculated as $14,369 for ITNM compared to conservative therapy. The analysis showed that there was a 100% probability of cost-effectiveness across various thresholds ranging from $20,000/QALY up to $150,000/QALY. Key factors influencing the model's outcomes were found to be the utility (quality-of-life impact) associated with being a responder to ITNM and parameters related to fall-related events.
It is important for students to understand that while this abstract provides detailed findings from a specific model run, it does not offer information on sample sizes for clinical trials underlying some of these parameters beyond what was mentioned for the OASIS trial (N=150). Additionally, details about the study population are limited in the abstract itself. The analysis adopts a US payer perspective and includes only direct medical costs. Some event risks were applied from general population-level sources and may not fully capture individual patient variations or heterogeneity.
The 3-year base-case horizon of the model might miss longer-term durability effects, although extended-horizon scenarios (not detailed in this abstract) reportedly support consistent findings. Overall, over a three-year period, ITNM with an external wearable battery was found to improve quality-adjusted survival and lower overall payer costs compared with conservative therapies for UUI. This supports its inclusion as a value-consistent minimally invasive therapy option from the perspective of healthcare payers in the US.
Source abstract
Study Overview
Implantable tibial nerve neuromodulation (ITNM) represents a minimally invasive intervention for urgency urinary incontinence (UUI). This study evaluated the 3-year cost-utility of ITNM with an external wearable battery (Revi System) versus conservative treatments (behavioral ± pharmacotherapy) from a US payer perspective. A cohort state-transition (Markov) model with annual cycles compared ITNM to conservative treatment modalities (behavioral ± pharmacotherapy). ITNM clinical parameters were derived from the OASIS pivotal trial ( = 150); parameter uncertainty was propagated20,000 Monte Carlo simulations. Health states captured responder and non-responder status with permitted transitions, rescue interventions (onabotulinumtoxinA, sacral neuromodulation, percutaneous tibial nerve stimulation), and downstream event modules (falls, urinary tract infection, incontinence-associated dermatitis, depression, cognitive decline/dementia, and nursing-home entry). Costs and quality-adjusted life-years (QALYs) were discounted at 3% annually and expressed in 2025 US dollars. Parameter uncertainty was assessed using probabilistic sensitivity analysis (PSA; 20,000 simulations) and tornado analysis. ITNM was both more effective and less costly than behavioral ± pharmacotherapy. Mean 3-year costs were $39,308 versus $43,737 (ΔCost = -$4,428), with mean QALYs of 2.188 and 1.940, respectively (ΔQALY = +0.249). The incremental cost-effectiveness ratio was -$17,818/QALY (dominant). Incremental net monetary benefit at $40,000/QALY was $14,369, with 100% probability of cost-effectiveness across thresholds from $20,000-$150,000/QALY. Key value drivers were responder utility and fall-related parameters. The analysis adopts a US payer perspective with direct medical costs only. Some event risks were applied from population-level sources and may not fully capture patient-level heterogeneity. The 3-year base-case horizon may miss longer-term durability effects, though extended-horizon scenarios support consistent findings. Over 3 years, ITNM with an external wearable battery improves quality-adjusted survival and lowers overall payer costs compared with conservative therapies for UUI, supporting its inclusion as a value-consistent minimally invasive therapy.
Evidence appraisal
Main Findings
- The database record does not provide key finding 1.
- The database record does not provide key finding 2.
- The database record does not provide key finding 3.
- The database record does not provide key finding 4.
- The database record does not provide key finding 5.
Practice transfer
Clinical Relevance
- Clinical implication 1 should be interpreted cautiously because the database record is limited.
- Clinical implication 2 should be interpreted cautiously because the database record is limited.
- Clinical implication 3 should be interpreted cautiously because the database record is limited.
- Clinical implication 4 should be interpreted cautiously because the database record is limited.
- Clinical implication 5 should be interpreted cautiously because the database record is limited.
Faculty notes
Educational Relevance
Cost-utility of implantable tibial neuromodulation (Revi) versus conservative therapy for urgency urinary incontinence in adults: a US payer perspective. can be used for source-grounded discussion. The database record does not provide enough detail for a fuller faculty summary.
Critical appraisal
Limitations
- The database record does not provide limitation 1.
- The database record does not provide limitation 2.
- The database record does not provide limitation 3.
Classroom use
Discussion Questions
- Discussion question 1: What does "Cost-utility of implantable tibial neuromodulation (Revi) versus conservative therapy for urgency urinary incontinence in adults: a US payer perspective." help nursing students evaluate?
- Discussion question 2: What does "Cost-utility of implantable tibial neuromodulation (Revi) versus conservative therapy for urgency urinary incontinence in adults: a US payer perspective." help nursing students evaluate?
- Discussion question 3: What does "Cost-utility of implantable tibial neuromodulation (Revi) versus conservative therapy for urgency urinary incontinence in adults: a US payer perspective." help nursing students evaluate?
- Discussion question 4: What does "Cost-utility of implantable tibial neuromodulation (Revi) versus conservative therapy for urgency urinary incontinence in adults: a US payer perspective." help nursing students evaluate?
- Discussion question 5: What does "Cost-utility of implantable tibial neuromodulation (Revi) versus conservative therapy for urgency urinary incontinence in adults: a US payer perspective." help nursing students evaluate?
- Discussion question 6: What does "Cost-utility of implantable tibial neuromodulation (Revi) versus conservative therapy for urgency urinary incontinence in adults: a US payer perspective." help nursing students evaluate?
- Discussion question 7: What does "Cost-utility of implantable tibial neuromodulation (Revi) versus conservative therapy for urgency urinary incontinence in adults: a US payer perspective." help nursing students evaluate?
- Discussion question 8: What does "Cost-utility of implantable tibial neuromodulation (Revi) versus conservative therapy for urgency urinary incontinence in adults: a US payer perspective." help nursing students evaluate?
- Discussion question 9: What does "Cost-utility of implantable tibial neuromodulation (Revi) versus conservative therapy for urgency urinary incontinence in adults: a US payer perspective." help nursing students evaluate?
- Discussion question 10: What does "Cost-utility of implantable tibial neuromodulation (Revi) versus conservative therapy for urgency urinary incontinence in adults: a US payer perspective." help nursing students evaluate?
Knowledge check
Quiz
1. What was the primary objective of this study?
- To evaluate the long-term durability effects beyond a 3-year horizon.
- To assess the cost-utility of implantable tibial neuromodulation (ITNM) versus conservative therapy for urgency urinary incontinence from a US payer perspective.
- To determine the sample size required for future clinical trials on ITNM.
- To compare patient satisfaction levels between ITNM and pharmacotherapy.
Rationale: The abstract explicitly states: 'This study evaluated the 3-year cost-utility of ITNM...versus conservative treatments...from a US payer perspective.'
2. Which specific device was used to deliver implantable tibial nerve neuromodulation (ITNM) in this study?
- OnabotulinumtoxinA.
- Sacral neuromodulation system.
- Revi System.
- Percutaneous tibial nerve stimulation.
Rationale: The abstract specifies: 'ITNM with an external wearable battery (Revi System) versus conservative treatments...'
3. What type of model was employed to compare ITNM and conservative therapy in this study?
- A cohort state-transition (Markov) model.
- A randomized controlled trial design.
- A systematic review methodology.
- An observational cohort study.
Rationale: The abstract states: 'A cohort state-transition (Markov) model with annual cycles compared ITNM to conservative treatment modalities...'
4. What was the duration of the cost-utility analysis conducted in this study?
- 1 year.
- 2 years.
- 3 years.
- 5 years.
Rationale: The abstract mentions: 'This study evaluated the 3-year cost-utility...' and provides mean costs and QALYs for a 'Mean 3-year' period.
5. What was the primary outcome measure used in this economic evaluation?
- Total patient-reported quality of life scores.
- Number of falls experienced by patients.
- Cost per Quality-Adjusted Life-Year (QALY).
- Overall survival rates.
Rationale: The abstract refers to 'costs and quality-adjusted life-years (QALYs)' being discounted, and the 'incremental cost-effectiveness ratio' is reported as '-$17,818/QALY'.
6. How did ITNM compare in terms of effectiveness versus conservative therapy?
- ITNM was less effective.
- ITNM had similar effectiveness.
- ITNM was more effective.
- Effectiveness could not be determined from the study.
Rationale: The abstract states: 'ITNM was both more effective and less costly than behavioral±pharmacotherapy. Mean 3-year costs were $39,308 versus $43,737...with mean QALYs of 2.188 and 1.940, respectively (ΔQALY = +0.249).'
7. What was the incremental cost-effectiveness ratio (ICER) for ITNM compared to conservative therapy?
- -$5,000/QALY.
- -$17,818/QALY.
- +$10,000/QALY.
- +$30,000/QALY.
Rationale: The abstract explicitly states: 'The incremental cost-effectiveness ratio was -$17,818/QALY (dominant).'
8. What does a negative incremental cost-effectiveness ratio indicate in this context?
- ITNM is more costly and less effective than conservative therapy.
- ITNM is equally costly but more effective.
- ITNM is both more effective and less costly than the alternative, making it dominant.
- The study's results are inconclusive.
Rationale: A negative ICER indicates that the intervention (ITNM) provides additional health benefits at a lower cost compared to the comparator (conservative therapy), thus being 'dominant' as stated in the abstract.
9. What was the probability of ITNM being cost-effective across various willingness-to-pay thresholds?
- 0%.
- 50%.
- 100%.
- 95%.
Rationale: The abstract states: 'with 100% probability of cost-effectiveness across thresholds from $20,000-$150,000/QALY.'
10. Which parameter was identified as a key value driver in the study's analysis?
- Responder utility.
- Fall-related parameters.
- Cost of ITNM device only.
- Sample size of OASIS trial.
Rationale: The abstract mentions: 'Key value drivers were responder utility and fall-related parameters.'
Study cards
Flashcards
What was the primary objective of this study?
To evaluate the 3-year cost-utility of implantable tibial nerve neuromodulation (ITNM) with an external wearable battery (Revi System) versus conservative treatments for urgency urinary incontinence (UUI) from a US payer perspective.
What type of model was used to compare ITNM and conservative therapies?
A cohort state-transition (Markov) model with annual cycles.
From which clinical trial were the ITNM clinical parameters derived?
The OASIS pivotal trial (n=150).
How many Monte Carlo simulations were run to propagate parameter uncertainty?
20000
What was the time horizon of the cost-utility analysis?
3 years.
At what annual discount rate were costs and quality-adjusted life-years (QALYs) discounted?
3% annually.
In which currency are the reported costs expressed?
2025
What was the mean 3-year cost for ITNM treatment?
$39,308.
What was the mean 3-year cost for behavioral ± pharmacotherapy?
$43,737.
What was the difference in costs (ΔCost) between ITNM and conservative therapy?
-
What were the mean 3-year QALYs for ITNM treatment?
2.188.
What were the mean 3-year QALYs for behavioral ± pharmacotherapy?
1.940.
What was the difference in QALYs (ΔQALY) between ITNM and conservative therapy?
+
What was the incremental cost-effectiveness ratio for ITNM compared to conservative therapy?
-$17,818/QALY (dominant).
At a $40,000/QALY threshold, what was the incremental net monetary benefit of ITNM?
$14,369.
What probability did the study assign to ITNM being cost-effective across thresholds from $20,000-$150,000/QALY?
100%.
Which two factors were identified as key value drivers in this analysis?
Responder utility and fall-related parameters.
What perspective was adopted for the cost-utility analysis?
A US payer perspective with direct medical costs only.
What is one limitation mentioned regarding event risks used in the model?
Some event risks were applied from population-level sources and may not fully capture patient-level heterogeneity.
What potential limitation was noted concerning the study's time horizon?
The 3-year base-case horizon may miss longer-term durability effects, though extended-horizon scenarios support consistent findings.
Search-ready answers
Frequently asked questions
What was the primary objective of this cost-utility analysis comparing ITNM (Revi System) and conservative therapy for UUI?
The study aimed to evaluate the 3-year cost-utility of implantable tibial nerve neuromodulation (ITNM with an external wearable battery, Revi System) versus behavioral ± pharmacotherapy from a US payer perspective for urgency urinary incontinence (UUI).
What type of model was used to compare ITNM and conservative treatments?
A cohort state-transition (Markov) model with annual cycles was employed.
From which clinical trial were the ITNM clinical parameters primarily derived?
The ITNM clinical parameters were primarily derived from the OASIS pivotal trial, involving 150 participants.
What specific outcomes were used to assess cost-utility in this study?
Costs and quality-adjusted life-years (QALYs) were used as the primary outcome measures for assessing cost-utility.
How many Monte Carlo simulations were run to propagate parameter uncertainty?
Parameter uncertainty was propagated using 20,000 Monte Carlo simulations.
What discount rate was applied annually to costs and QALYs in this analysis?
Costs and quality-adjusted life-years (QALYs) were discounted at a rate of 3% annually.
In what currency and year are the reported cost figures expressed?
The costs were expressed in US dollars for the year 2025.
What was the incremental cost-effectiveness ratio (ICER) calculated for ITNM compared to conservative therapy over 3 years?
The incremental cost-effectiveness ratio (ICER) for ITNM versus behavioral ± pharmacotherapy was -$17,818 per QALY.
What were the mean 3-year costs and QALYs associated with ITNM compared to conservative therapy?
Over 3 years, ITNM had mean costs of $39,308 versus $43,737 for conservative therapy (a cost saving of -$4,428), and mean QALYs of 2.188 versus 1.940 respectively.
What was the probability that ITNM is considered cost-effective across a range of willingness-to-pay thresholds?
The analysis showed 100% probability of ITNM being cost-effective across threshold values from $20,000 to $150,000 per QALY.