Confidanz®: a new approach to overactive bladder, designed for home
Confidanz® is an investigational wearable that stimulates the tibial nerve at the ankle,
designed for overactive bladder (OAB), including urinary urgency, frequency, and waking at
night to urinate (nocturia).
How it works
With overactive bladder, the nerves that control the bladder signal an urge to go before
the bladder is full. The tibial nerve runs from the ankle to the base of the spine, to
nerve roots it shares with the bladder. Confidanz sends small electrical pulses into the
tibial nerve at the ankle, and is designed to calm those bladder signals.
In the SUmiT trial of in-clinic tibial nerve stimulation (PTNS), 2.6 times as many people
improved with PTNS as with a sham: 54.5% of 220 adults said their symptoms had moderately
or markedly improved, against 20.9% with a sham. In a 3-year follow-up of the people PTNS
worked for, about 3 in 4 were still improved, with 3 fewer bathroom trips and 90% fewer
urge leaks a day. That is evidence for in-clinic PTNS; Confidanz has not been tested yet.
How it compares with PTNS today
In-clinic PTNS means a clinic visit every week for 12 weeks. Confidanz is designed to be
set up by a clinician and then used at home. Unlike in-clinic PTNS, it has not been tested
yet.
Using it
-
Set up by a clinician: a clinician fits the Smart Patch at the ankle
-
Paired with the app: the app connects over Bluetooth and guides each
session
- Used at home: the clinician reviews every session online
© Australis Scientific Pty Ltd. Confidanz® Smart Patch is an investigational device
and has not received market authorisation for sale.