- Design
- Randomised controlled trial
- Population
- 109 men with incontinence after radical prostatectomy
- Primary outcome
- ≥50% reduction in 24-hour pad weight at 12 weeks
- Effect
- 52.1% success overall; device vs physiotherapist OR 1.19 (0.53 to 2.66)
This randomised trial assigned 109 men with incontinence after radical prostatectomy to pelvic floor training with a non-invasive biofeedback device (55) or a physiotherapist (54). Both groups also did 12 weeks of whole-body high-effort resistance training.
Both groups improved on the 24-hour pad test (mean reduction 86 g). The primary endpoint, at least a 50% reduction in leakage, was reached by 52.1% overall with no difference between groups (OR 1.19, 95% CI 0.53 to 2.66). A post hoc look at responders favoured the device, but this was exploratory. Longer time since surgery predicted less success; age did not.
The practical point is that a home device may be a reasonable substitute where physiotherapy access is limited, which is common in India. The trial was small and retrospectively registered, and its equivalence is an absence of detected difference rather than a formal non-inferiority result.
- Start pelvic floor training early after prostatectomy; longer time since surgery predicted less success.
- Offer a biofeedback device as an alternative where physiotherapist-led training is not accessible.
- Measure leakage objectively with a 24-hour pad test before and after training.
- Expect about half of men to halve their leakage with 12 weeks of training.
Why it matters
It widens access to continence rehabilitation where specialist physiotherapy is scarce.
Don't overread it
Small, retrospectively registered trial not designed for non-inferiority; no difference is not proof of equivalence.
The statistics, in plain English
An odds ratio of 1.19 with an interval from 0.53 to 2.66 means the device could be roughly half as effective or more than twice as effective; the trial cannot tell which.
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