Urgent ® PC Neuromodulation System
For overactive bladder and associated symptoms of urinary urgency, urinary frequency and urge incontinence.
The Urgent PC Neuromodulation System is an effective, office-based method for stimulating confidence and control in patients when conservative therapies fail.
- Provides percutaneous tibial nerve stimulation: a slim needle electrode, inserted near the tibial nerve, carries electric impulses from a hand-held stimulator to the sacral plexus
- 30-minute treatment sessions
- After the 12 initial treatments, some patients may need occassional sessions to sustain symptom relief
- Most common side-effects are temporary and include mild pain or skin inflammation at or near the stimulation site
- Patient response rates of up to 80%
- Documented reductions in daytime voiding frequency, nighttime voiding frequency and leakage episodes
- Statistically superior to validated sham therapy in a double-blind RCT
- Results maintained at a three year mean follow-up when initial series was followed by maintenance therapy
- In a double-blind placebo study, 71% of patients responded (defined as >50% reduction in voids per day) to treatment with Urgent PC. According to this criteria, no patients in the placebo group were considered responders.
|2012||PTNS included in AUA/SUFU Treatment Guideline, " Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults"|
Category 1 CPT Code, 64566, specific to PTNS, effective January 1, 2011.
The United Kingdom's National Institute of Clinical Excellence (NICE) issues a guidance for the use of PTNS in the treatment of Overactive Bladder.
The American Medical Association establishes a new Category I CPT Code, 64566, specific to PTNS.
Randomized studies are conducted comparing Urgent PC to medical and sham treatment.
Uroplasty develops the next generation of Urgent PC featuring a new control interface and an ergonomic design.
Uroplasty updates the Urgent PC technology and obtains FDA 510(k) clearance for the Urgent PC stimulator and lead set.
Uroplasty begins to commercialize Urgent PC in the United States.
CystoMedix initiates limited US launch.
Uroplasty signs licensing agreement with Cystomedix, Inc. to acquire the Urgent PC technology.
CystoMedix begins distribution in Europe with a modified SANS device renamed Urgent PC.
CystoMedix acquires particular UroSurge assets related to SANS device.
FDA 510(k) clearance received for the Stoller Afferent Nerve Stimulator (SANS) device, the precursor to Urgent PC. UroSurge, the manufacturer, begins distribution in the United States.
UroSurge, the manufacturer of the SANS device, files for bankruptcy.
Dr. Govier, et al initiates multi-center prospective safety and efficacy study of percutaneous tibial nerve stimulation for overactive bladder.
CE Mark received for the Stoller Afferent Nerve Stimulator (SANS) device, the precursor to Urgent PC. UroSurge, the manufacturer, began distribution in Europe.
First published clinical data on percutaneous tibial nerve stimulation by Stoller and Govier.
Patent issued for method of using needle electrode for percutaneous tibial nerve stimulation.
Dr. Stoller initiates a 10-year period of patient study to apply intermittent percutaneous stimulation of the tibial nerve in 98 patients.