Authors' objectives: This health technology assessment evaluates the effectiveness, safety, and cost-effectiveness of percutaneous vertebroplasty and percutaneous balloon kyphoplasty for adults with painful osteoporotic vertebral compression fractures. It also evaluates the budget impact of publicly funding percutaneous vertebroplasty and balloon kyphoplasty and the experiences, preferences, and values of people with painful osteoporotic vertebral compression fractures.

Authors' results and conclusions: RESULTS: There is currently no evidence for head-to-head comparison between paclitaxel-coated balloon dilation and direct vision internal urethrotomy (the most common treatment method for bulbar recurrent urethral stricture in Ontario) or between paclitaxel-coated balloon dilation and surgical urethroplasty (the gold standard treatment). We identified 1 randomized controlled trial that compared outcomes of treatment with paclitaxel-coated balloon with other endoscopic methods in patients with short bulbar urethral stricture (≤ 3 cm; ROBUST III trial). This trial used Kaplan-Meier analysis and reported a statistically significant difference in freedom from repeat intervention at 1 year, favouring the intervention group (GRADE: Low). However, this estimate was likely skewed by the fact that there were participants in the intervention group who failed the treatment but did not undergo reintervention. These cases were excluded (censored) from the analysis, which made the intervention look more effective than it might actually be. Furthermore, outcomes for each of the various endoscopic methods included in the control group were not analyzed individually. Paclitaxel-coated balloon treatment may improve bothersome urinary symptoms and urine flow rate (GRADE: Low). Sexual function was not affected by the treatment in either group (GRADE: Moderate). The rate of hematuria and dysuria during the first month after treatment was higher in the intervention group than in the control group (GRADE: Moderate). We identified 2 economic studies which found that paclitaxel-coated balloon dilation was potentially cost saving at 5 years compared with usual endoscopic procedures. However, these studies were not directly applicable to the Ontario context. Our economic evaluation from the Ministry of Health perspective found that, compared with usual care over 5 years, paclitaxel-coated balloon dilation could be less costly (mean: -$1,476.44; 95%; credible interval [CrI]: -$3,217.15 to $112.40 per person) and more effective (showing a decrease in the recurrence of urethral strictures at 5 years; mean: 69%; 95% CrI: 68% to 70%). In the reference case analysis, the new treatment was cost-saving about 97% of the time. However, currently published clinical evidence that informed modeling of the effectiveness of this technology was limited and of low quality. In scenario analyses, the cost-effectiveness results were sensitive to changes in the effectiveness of paclitaxel-coated balloon dilation, duration of time horizon, and device cost. The 5-year budget impact of publicly funding paclitaxel-coated balloon dilation in eligible males is potentially cost saving, with net savings of about $0.74 million from treating 2,747 adult males in Ontario. Assuming a high rate of the procedure uptake from 50% in year 1 to 100% in year 5, we found additional costs of about $0.28 million in the first year of funding and annual savings for the remaining years ranging between $0.02 million and $0.58 million. The people with bulbar urethral strictures with whom we spoke reported hesitancy about undergoing urethroplasty and viewed paclitaxel-coated balloon dilation favourably due to it being a minimally invasive procedure. Barriers to access included lack of awareness of the procedure, the out of pocket cost when accessing it through a private clinic, and distance from hospitals or clinics performing the procedure. CONCLUSIONS People who are refractory to first-line conservative treatment and who underwent PVP showed significant short-term clinical improvement in pain (GRADE Low) and physical function (GRADE Very low) compared to conservative treatment. Similarly, people who underwent PBK experienced significant short-term clinical improvement in pain (GRADE Very low) compared to conservative treatment. PVP and PBK were consistently more costly and more effective than CT. We estimate that publicly funding PVP and PBK in Ontario would result in additional costs of $28 million over the next 5 years. The insights shared by participants underscore the significant challenges individuals with OVCF face in managing their condition, with notable impacts on daily activities, work, social interactions, and mental health. Despite these challenges, participants highlighted the positive outcomes of vertebroplasty for those who underwent the procedure, particularly in terms of pain relief and improved quality of life.

Authors' recommendations: Ontario Health, based on guidance from the Ontario Health Technology Advisory Committee, recommends publicly funding paclitaxel-coated balloon dilation for adults with recurrent bulbar urethral stricture.

Authors' methods: We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using the ROBIS tool for systematic reviews, the Cochrane Risk of Bias tool for RCTs, and the ROBINS-I tool for observational studies and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search and conducted a cost-utility analysis with a 3-year time horizon from a public payer perspective. We also analyzed the budget impact of publicly funding PVP and PBK in adults with painful OVCFs in Ontario. To contextualize the potential value of PVP and PBK, we spoke with people with OVCF.

Project Status: Completed

URL for project: https://ontariohealth.ca/system/health-innovation-pathway/reviews/hta-details?cf=paclitaxel-coated-balloon-dilation-for-adults-with-recurrent-bulbar-urethral-stricture

URL for protocol: https://www.crd.york.ac.uk/PROSPERO/view/CRD42024563567

Year Published: 2026

URL for published report: https://pmc.ncbi.nlm.nih.gov/articles/PMC13268791/

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Canada

Province: Ontario

Pubmed ID: 42311576

Organisation Name: Ontario Health

Contact Address: 525 University Ave, Toronto, ON M5G 2L3

Contact Name: HealthInnovationPathway@ontariohealth.ca

Contact Email: HealthInnovationPathway@ontariohealth.ca

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