A biofeedback device matched a physiotherapist for post-prostatectomy leakage

Design

Randomised controlled trial, 12 weeks, ClinicalTrials.gov NCT06206993

Population

109 men after radical prostatectomy for localised prostate cancer; 55 device-assisted, 54 physiotherapist-guided; 96 (88%) completed

Primary outcome

Treatment success, defined as at least 50% reduction in 24-hour pad weight at 12 weeks

Effect

52.1% success overall, no between-group difference (OR 1.19, 95% CI 0.53-2.66, p=0.670); mean pad weight change -86.39 g (SD 336.25, p<0.001)

Pelvic floor muscle training after radical prostatectomy works; the constraint is access to a physiotherapist who can teach it. This randomised trial asked whether a non-invasive biofeedback device could stand in.

Men after radical prostatectomy for localised prostate cancer were randomised to device-assisted pelvic floor training (n=55) or conventional physiotherapist-guided training (n=54). Both groups also did a 12-week whole-body high-effort resistance programme at over 60% of one-repetition maximum, performed to momentary failure. Leakage was measured objectively with the 24-hour pad weight test at baseline and at 12 weeks, and treatment success was prespecified as a reduction of 50% or more.

Ninety-six men (88%) completed. Everyone improved — mean change in 24-hour pad weight was -86.39 g (SD 336.25, p<0.001) — and 52.1% reached treatment success. There was no difference between groups (OR 1.19, 95% CI 0.53-2.66, p=0.670). A post hoc analysis limited to men who succeeded found a greater relative reduction in the device group (-83.97% versus -74.68%, p=0.017), which the authors themselves flag as unadjusted for multiple testing.

The predictor finding is the practically useful one: time since surgery was a significant negative predictor of success (p<0.001), while age was not. The men who start late do worse, and that is something a service can act on.

• Start pelvic floor training early — time since surgery predicted failure, age did not
• A device is a reasonable substitute where physiotherapy access is the limiting factor
• Just over half reached a 50% reduction at 12 weeks; set that expectation at the outset
• The 24-hour pad test is the objective measure; ask for pad weight, not pad count
• Both arms also did whole-body resistance training, so neither result is pelvic floor work alone

Why it matters

It removes physiotherapist availability as a reason for a man not to start pelvic floor training.

Don't overread it

The apparent device advantage came from a post hoc analysis in a selected subgroup without multiplicity adjustment.

The statistics, in plain English

The standard deviation of the pad-weight change (336 g against a mean of -86 g) is enormous, which tells you the men varied wildly — some improved hugely, some not at all, and the average conceals both. That is why the prespecified binary endpoint of 50% reduction is the more honest measure. The post hoc finding favouring the device was restricted to men who had already succeeded and was not corrected for multiple testing, so it should change nothing.

Read the rest in the app

You have read your two free briefings this month. The app carries all 27 specialties, every morning, free — and this finding is waiting in it.

Get Daily Doctor — free

Scan to keep reading on your phone. No account needed to start.