tibial nerve

StimGuard Launches Head-to-Head Trial Against Medtronic’s InterStim

StimGuard yesterday announced plans for a clinical trial comparing its nerve stimulator with the InterStim sacral nerve stimulator made by Medtronic (NYSE:MDT).  Pompano Beach, Fla.-based StimGuard is already running a pivotal study of its technology, a miniature implantable device designed to treat urinary incontinence resulting from refractory overactive bladder syndrome. The device is implanted at the tibial nerve through a needle-sized introducer and uses wireless technology to stimulate the nerve. Read more.

Source: Massdevice, March 1, 2018

sacral nerve stimulation

Medtronic Touts 5-Year Data on InterStim Neuromod Device for OAB

Medtronic today touted 5-year results from the InSite study of its InterStim neuromodulation treatment for overactive bladder syndrome.  InterStim is designed to stimulate the sacral nerve to treat OAB, meaning urinary urge incontinence and/or urgency-frequency. The InSite study enrolled 340 patients, of which 272 were implanted with an InterStim device, comparing treatment with the device with standard drug therapy. The primary safety endpoint was to “demonstrate that the upper bound of the 95% CI for the cumulative five-year rate of adverse events related to the tined lead that require surgery is less than 33%” at 5 years, according to ClinicalTrials.gov. The primary efficacy endpoint was superior improvement in OAB symptoms at 6 months. Read more.

Source: MassDevice Today, July 17, 2017

female doctor

Botox Beats Implant for Urinary Incontinence in Women

For women with bladder incontinence who haven’t been helped by medications or other therapies, Botox injections may help control leakage better than an implanted nerve stimulation device, a new study suggests. However, both treatments are effective, according to doctors who treat the condition. In a head-to-head comparison, women given Botox saw their number of daily urgency incontinent episodes decrease by four, on average, compared to three for women who received the implant, called InterStim.  Botox patients also said they had a greater reduction in symptoms and were more satisfied with the treatment, the researchers said.  Read more.

Source: HealthDay News, October 4, 2016