Noninvasive approach may be sufficient for OAB management in women

Augmenting comprehensive clinical assessment (CCA) with invasive urodynamic investigations does not appear to benefit women with refractory overactive bladder (OAB) symptoms in the FUTURE* study presented at EAU25.

In the intention-to-treat (ITT) analysis, PGI-I** success rates at the last follow-up were similar regardless of whether women did or did not receive routine urodynamics on top of CCA (23.6 percent vs 22.7 percent; adjusted odds ratio [aOR], 1.12; p=0.60 [strict definition] and 43.8 percent vs 41.6 percent; aOR, 1.14; p=0.47 [less strict definition]).

According to Professor Mohamed Abdel-Fattah from the Aberdeen Centre for Women’s Health Research at the University of Aberdeen in the UK, the original or strict definition of PGI-I success corresponds to ‘very much improved’ or ‘much improved’ following treatment; the less strict definition includes both strict definition metrics plus ‘improved’.

The pattern observed in the ITT analysis was similarly seen in the per-protocol (PP) analysis (24.9 percent vs 23 percent; aOR, 1.22; p=0.39 [strict] and 45.2 percent vs 42.2 percent; aOR, 1.21; p=0.32 [less strict]). [Lancet 2025;405:1057-1068]

Of note, the ITT and PP analyses were done post-randomization until the last follow-up timepoint, Abdel-Fattah noted. “Therefore, patients may have had treatments such as [BoNT-A***], but the treatment effects may have started to wane. So, we asked a subgroup of women who had BoNT-A to [determine] their success rates post-BoNT-A by 2 months.”

The PGI-I success rates 2 months post-BoNT-A were higher than those observed in the ITT and PP analyses, be it with the original (63.8 percent [combo] vs 60 percent [CCA only]) or less strict definition (83.3 percent vs 76.4 percent). However, the between-group differences still fell short of statistical significance (aOR, 1.17; p=0.52 and aOR, 1.47; p=0.20, respectively).

“[The PGI-I success results provide] confidence in the robustness of the results. Whether we use the strict or less strict definition, post-randomization or post-treatment, [ITT or PP], there was no evidence of significant differences in patient-reported success rates following treatment in [both] arms,” Abdel-Fattah said.

“We have also done a sensitivity analysis using imputation of results and considering all missing [variables]; again, this has provided more confidence in our results,” he added.

Other outcomes, safety

Looking at the change in urgency from baseline to final follow-up, there were no significant between-group differences in the percentages of women who, as per the Urgency Perception Scale, were classified as cured (4.9 percent [combo] vs 2.8 percent [CCA only]; aOR, 2.04; p=0.10), improved (40.1 percent vs 38.8 percent; aOR, 1.12; p=0.53), or had no change (46.7 percent vs 50.3 percent; aOR, 0.84; p=0.34).

About 60 percent of women in the combination arm received BoNT-A, while nearly 72 percent did in the CCA-only arm. Conversely, more women in the former vs the latter arm received surgery for stress urinary incontinence (UI; 3.4 percent vs 1 percent), sacral neuromodulation (2.4 percent vs 1.7 percent), and hydro-distention ± urethral dilatation (4.7 percent vs 0.6 percent). “[These differences suggest] that urodynamics have led to changes in treatment decisions and treatments received. [Nonetheless, these changes] did not equate to better patient-reported success rates,” Abdel-Fattah noted.

In terms of adverse events, the combination and CCA-only arms had comparable rates of urinary tract infections (7.1 percent vs 7.5 percent), prophylactic antibiotic use (7.3 percent vs 6.6 percent), and clean intermittent self-catheterization required (4.7 percent vs 5.8 percent).

Looking at the cost-effectiveness acceptability curve, urodynamics had a 34-percent probability of being cost-effective at a willingness-to-pay threshold of GBP20,000 per quality-adjusted life year (QALY) gained, which, according to Abdel-Fattah, is the NICE^#-recommended threshold. However, when longer treatment effects (including treatment discontinuations and other factors) were incorporated, the probability dropped to 23 percent.

Results will lead to changes in guidelines, practice

The study included 1,099 women with refractory OAB or urgency-predominant mixed UI (MUI) who have failed conservative treatment (eg, pelvic floor muscle/bladder training), have failed or have not tolerated pharmacological intervention (at least two different drugs) unless contraindicated, and are being considered for further invasive treatment.

They were randomized 1:1 to receive CCA with or without urodynamics. The noninvasive CCA included a detailed medical history, clinical exam, 3-day bladder diary, and bladder scan for post-voiding residual urine volume ± noninvasive uroflow. Urodynamics included subtracted cystometry and uroflowmetry ± pressure flow studies ± urethral pressure profile. Overall, the average participant age was 59 years and nearly half had a BMI >30 kg/m².

“In women with refractory OAB or urgency-predominant MUI, the participant-reported success in the urodynamics + CCA arm was not superior to the CCA-only group,” said Abdel-Fattah. “Moreover, urodynamics was not cost-effective at the GBP20,000 per QALY gained threshold.”

In the published report, Abdel-Fattah and colleagues noted that the findings will lead to guideline adjustments on the management of UI in women and subsequently change clinical practice.

“Women with refractory OAB and urgency-predominant MUI will be offered invasive treatments, such as BoNT-A injection into the bladder wall, based on results from the CCA only. This significant evidence-based change will lead to women experiencing earlier improvement in their quality of life and avoidance of unnecessary invasive investigations,” they said.

They added that implementing these results can lead to significant cost savings in healthcare resources in countries with healthcare systems similar to the UK.