Urgent PC Stimulator Treatment Steps Guide Rev F May 2018

Urgent PC Neuromodulation System ®

Since 2003, Urgent PC has set the standard for Percutaneous Tibial Nerve Stimulation (PTNS) performance, both in clinical studies and in clinical practice.

Proven Option: For most patients with associated symptoms of overactive bladder (OAB) Urgent PC is low-risk with few contraindications and no severe adverse events. Urgent PC is a good option for most patients suffering from urinary urgency, urinary frequency, and urge incontinence. PTNS is a recommended therapy in the AUA/SUFU OAB Guideline.1 • Office-based neuromodulation • Effective in both men and women, regardless of age2 • Low-risk with few contraindications and no severe adverse events • May be combined with behavioral and drug therapies URGENT PC CANDIDATES INCLUDE THOSE:

Too old and/or frail for other therapies Suffering intolerable side-effects from other therapies Experiencing insufficient response to drugs Already receiving BOTOX® injections Unwilling to perform self-catheterization Who want a non-drug, non-surgical option

UPDATE ON ANTICHOLINERGICS

Anticholinergic use for ≥3 months increased the risk of dementia on average by an estimated 46% versus non-use. This relationship was consistent in studies assessing overactive bladder medications. The risk of developing dementia should be carefully considered in the context of potential benefit before prescribing anticholinergics.3

02

Laborie Urgent PC ®

▼ The tibial nerve is easily accessed in the lower leg. Stimulation travels from the point of entry near the ankle, up the tibial nerve and to the sacral plexus.

Proven Effective: 50 studies demonstrate product performance

▼ Urgent® PC Superior to Sham (p<0.001)

Patients Reporting Improvement at 12 Weeks 4

A robust data set demonstrates that PTNS with Urgent PC is effective with consistent results in 3 randomized controlled trials (RCTs), 3 durability studies, 2 metaanalyses and over 50 peer-reviewed articles.

55%

21%

• Statistically superior to sham in reducing frequency, incontinence episodes, nighttime voids and urgency 4 • Superior subjective response to leading drugs with statistically significant reductions in OAB symptoms 5,6 • At 3 years follow-up, all quality-of-life (QoL) parameters remained markedly improved with about 1 treatment a month (all p<0.0001)7

Urgent® PC

Sham

▼ Urgent® PC Objective Success

Results from RCTs and Meta-Analyses

80%

71%

Patient Preferred: Refractory treatment for associated symptoms of OAB • First choice among next line therapies for patients who are refractory to conservative and drug therapies8

61%

S PTN 57 %

Sa

Peters5 Finazzi-Agrò9 MacDiarmid10 Burton 11 n=244 n=50 n=18 n=940 Meta-Analysis

n

RCT

tio

PTNS treatment is preferred by patients8

% 3 4 odu N e u ro m

la

%

9 OX B OT

• 98% of patients were willing to try PTNS8

71%

c ra l

▼ Urgent® PC Sustained Effectiveness7

Objective Improvement in Responders Attending 3 Year Visits

Proven Valuable: Expands Clinical Practice • In a community practice, 77.5% of responders continued long-term therapy with a treatment every 1-3 months12 • Delivered by qualified support staff under physician supervision • Treat more patients using group appointments and staggered start times • CPT® code 64566: national Medicare reimbursement; numerous private payer coverage policies

15 12

-3.3

< 0.0001

-5.0

9

< 0.0001

6

-3.4

< 0.0001

3 0

Frequency Baseline

Urgency

Incontinence Episodes

13 Weeks

-1.0

< 0.0001

Nighttime Voids 3 Years

• Wide range of support tools, codeveloped with clinical practitioners

03

The proven PTNS device THE URGENT PC NEUROMODULATION SYSTEM

• Option for most patients experiencing associated symptoms of OAB such as urinary urgency, urinary frequency, and urge incontinence • Up to 80% patient response in men and women2,4–11 • More than a million treatments since 2003 • Easy to integrate into clinical practice

Ordering Information Product Description Reusable Urgent® PC Stimulator 1 Hand-held Stimulator, 1 9-Volt Battery, 1 Screwdriver, 1 Instructions for Use

Urgent PC Lead Sets 12 Lead Sets/box, 1 9-Volt Battery, 1 Instructions for Use

Product Code

Box Quantity

UPC 200

1 unit

UPC 250-12

12 Lead Sets

1. Gormley, E.A, Lightner, D.J., Burgio, K.L., Chai, T.C. Clemens, J.Q, Culkins, D.J, et. al. (2014). Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU Guideline. Retrieved Sept. 8, 2014 from http://www.auanet.org/content/media/OAB_guideline.pdf. 2. Peters, K., Carrico, D. (2013). Clinical insights into percutaneous tibial nerve stimulation (PTNS) versus sham therapy for the treatment of overactive bladder syndrome (OAB): secondary analysis of the SUmiT Trial. Poster presentation, SUFU winter meeting, Las Vegas, NV. 3. Dmochowski, R.R., Thai, S., Iglay, K., Enemchukwu, E., Tee, S., Varano, S., et al. (2020). Increased risk of incident dementia following use of anticholinergic agents: A systematic literature review and meta-analysis. Neurourol Urodyn. 2020 Oct 23. doi: 10.1002/nau.24536. Epub ahead of print. PMID: 33098213. 4.  Peters, K.M., Carrico, D.J., Perez-Marrero, R.A., Khan, A.U., Wooldridge, L.S., Davis, G.L., et al. (2010). Randomized trial of percutaneous tibial nerve stimulation versus sham efficacy in the treatment of overactive bladder syndrome: results from the SUmiT Trial. J Urol, 183, 1438–43. 5.  Peters, K.M., Leong, F.C., Shobeiri, S.A., MacDiarmid, S.A., Rovner, E.S., Wooldridge, L.S., et al. (2009). A randomized trial of percutaneous tibial nerve stimulation versus extendedrelease tolterodine: results from the Overactive Bladder Innovative Therapy trial. J Urol, 182, 1055–61. 6.  Vecchioli-Scaldazza, C., Morosetti, C., Beouz, A., Giannubilo, W., Ferrara, V. (2013). Solifenacin succinate versus percutaneous tibial nerve stimulation in women with overactive bladder syndrome: results of a randomized controlled crossover study. Gynecol Obstet Invest, 75(4), 230–4. 7.  Peters, K.M., Carrico, D.J., Wooldridge, L.S., Miller, C.J. & MacDiarmid, S.A. (2013). Percutaneous tibial nerve stimulation (PTNS) for the long-term treatment of overactive bladder: three-year results of the STEP Study. J Urol, 189(6), 2194–2201. 8.  Hashim, H., Beusterien, K., Bridges, J.G., Amos, K. & Cardozo, L. (2015). Patient preferences for treating refractory overactive bladder in the UK. Int Urol Nephrol. Sept. 7 [Epub ahead of print]. 9.  Finazzi-Agrò, E., Petta, F., Sciobica, F., Pasqualetti, P., Musco, S., & Bove, P. (2010). Percutaneous tibial nerve stimulation effects on detrusor overactivity incontinence are not due to a placebo effect: a randomized, double-blind, placebo controlled trial. J Urol, 184, 2001–06. 10. M  acDiarmid, S.A., & Staskin, D.R. (2009). Percutaneous tibial nerve stimulation (PTNS): a literature-based assessment. Curr Bld Dysf Rept, 4, 29–33. 11. Burton, C., Sajia, A., & Latthe, P.M. (2012). Effectiveness of percutaneous posterior tibial nerve stimulation for overactive bladder: a systemic review and meta-analysis. Neurourol Urodyn, 31(8), 1206–16. 12. Leong, F.C., McLennan, M.T., Barr, S.A., & Steele, A.C. (2011). Posterior tibial nerve stimulation in patients who have failed anticholinergic therapy: efficacy and time to response. Female Pelvic Med Reconstr Surg, 17(2), 74–5. Rx Only. CONTRAINDICATIONS: Treatment with Urgent PC is contraindicated for patients with pacemakers or implantable defibrillators, patients prone to excessive bleeding, patients with nerve damage that could impact either percutaneous tibial nerve or pelvic floor function, or patients who are pregnant or planning to become pregnant during the duration of the treatment. PRECAUTION: Exercise caution for patients with heart problems related to pacing. Most patients do not experience side-effects. If side-effects occur, they are typically temporary and include mild pain and skin inflammation at or near the stimulation site. For complete instructions for use, storage, warnings, indications, contraindications, precautions, adverse reactions and disclaimer of warranties, please refer to the insert accompanying each Urgent PC product. Models are for illustrative purpose only. Urgent, CPT, and BOTOX are registered trademarks. Urgent PC is manufactured by Uroplasty LLC. © 2022 Laborie. All rights reserved.

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