Fesoterodine: 4 SOFIA Trial Checks

The US AUA/SUFU¹ guideline recommends discussing potential dementia and cognitive risks before prescribing an antimuscarinic for overactive bladder. It also advises reviewing benefit and side effects within four to eight weeks of starting medication. Those questions belong in the initial appointment, alongside the symptom you want to change.¹

Who entered?

SOFIA randomized 794 adults aged 65 or older to placebo or fesoterodine, initially 4 mg/day with optional escalation to 8 mg, for 12 weeks. Diary completion was required; mean baseline MMSE cognitive-screen score was about 28/30. Significant kidney disease was excluded. Dose escalation was not separately randomized.²

Tell the prescriber whether your problem is a sudden need to urinate, leaking before reaching the toilet or frequent trips without leaking. Bring a recent diary and the actual medicine packages, including products bought without a prescription. Ask which symptom will determine whether this prescription is helping.

What improved?

At week 12, the adjusted additional reduction was 1.54 urgency episodes/day versus placebo (95% CI 0.97–2.12). This was the primary endpoint. The secondary urge-leak comparison was inconclusive (P=.73), not proof of equal effects.²³

Write down urgency and leaks in separate columns. For a trip to the cinema, “I can wait through the film” and “I no longer leak on the walk to the bathroom” describe different goals. Ask which change you should record before the review rather than combining both into “better bladder control.”

Who was counted?

The efficacy set included 756/794 participants, with missing outcomes carried forward from earlier visits. Discontinuation was 20% versus 13%. Pfizer funded and helped design, analyze and write the study; authors had industry ties.²

Bring a record of doses missed or stopped as well as the diary. A review based only on the days you managed to take the medicine leaves the prescriber without the reasons you skipped it. Arrange a contact for side effects before leaving with the prescription.

What did monitoring miss?

Dry mouth occurred in 34% versus 5%; constipation in 9% versus 3%. Stable 12-week MMSE averages cannot establish long-term dementia safety.²

The current US Toviaz label contraindicates use with urinary retention, gastric retention or uncontrolled narrow-angle glaucoma. It cautions against use with severe constipation or significant bladder-outlet obstruction. Kidney function and strong CYP3A4 inhibitors can limit the dose; ask the pharmacist to check the full medication list before any increase.⁴

Swallow the extended-release tablet whole. The label warns about dizziness and sleepiness: avoid driving until you know its effects. Other antimuscarinics can increase adverse effects. Seek urgent help for inability to urinate; stop taking it and obtain immediate medical help for swelling of the tongue or throat or difficulty breathing.⁴

Ask: “What benefit would justify continuing, and what would make you choose another treatment?” The AUA/SUFU¹ guideline permits switching medication when benefit is inadequate or side effects are intolerable, including to another drug class.¹

For questions about cognitive screening, see our mirabegron memory-trial guide.

The medicines section of Laugh, Sneeze, Jump explains prescription choices, cumulative anticholinergic exposure and questions to bring to a prescriber. Use it with the diary and medication list, so the discussion includes the trips you want to reduce and the side effects you are willing to accept.