Urgent ® PC Neuromodulation System
For Overactive Bladder and Faecal Incontinence
The Urgent PC System is an effective, outpatient method for treating the overactive bladder symptoms of urinary urgency, urinary frequency and urge incontinence. It is also used to treat faecal incontinence.
Simple Procedure
- Percutaneous Tibial Nerve Stimulation (PTNS) delivered via a thin needle electrode inserted in the patient's ankle (see Step-by-Step Treatment Guide)
- Electrical impulses travel through the tibial nerve to the sacral plexus, the nerves responsible for bladder function
- Initial series of 12, 30-minute outpatient treatments, responders may need occasional treatments for sustained symptom relief
- Well-tolerated by patients
- May be administered by specialised nurses; consultant prescribed
In the Treatment of Urinary Symptoms
- Patient response rates of up to 80%
- Documented reductions in daytime voiding frequency, nighttime voiding frequency and leakage episodes
- 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.
- Superior to validated sham treatment
In the Treatment of Faecal Incontinence
Up to 78% of patients achieved a long-term improvement in faecal incontinence (see chart)
Product History
| 2011 |
The United Kingdom's National Institute of Clinical Excellence (NICE) issues a guidance for the use of PTNS in the treatment of faecal incontinence. |
| 2010 |
The United Kingdom's National Institute of Clinical Excellence (NICE) issues a guidance for the use of PTNS in the treatment of Overactive Bladder. |
| 2007-2009 |
Randomized studies are conducted comparing Urgent PC to medical and sham treatment for the treatment of Overactive Bladder. |
| 2006 |
Uroplasty develops the next generation of Urgent PC featuring a new control interface and an ergonomic design. |
| 2005 |
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 for the treatment of Overactive Bladder. |
| 2004 |
CystoMedix initiates limited US launch. Uroplasty signs licensing agreement with Cystomedix, Inc. to acquire the Urgent PC technology. |
| 2003 |
CystoMedix begins distribution in Europe with a modified SANS device renamed Urgent PC. |
| 2002 |
CystoMedix acquires particular UroSurge assets related to SANS device. |
| 2000 |
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. |
| 1999 |
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. |
| 1993 |
Patent issued for method of using needle electrode for percutaneous tibial nerve stimulation. |
| 1987 |
Dr. Stoller initiates a 10-year period of patient study to apply intermittent percutaneous stimulation of the tibial nerve in 98 patients. |
40008A 03/12
Procedure Video
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