1. Overactive Bladder: Diagnosis and Treatment Chase Kenyon Sovell, MD Urology Associates May 30 th, 2007 Pearls of Plumbing Seminar

2. Overview of Bladder Problems Can’t void Void too often Urinary leakage

3. Bladder Function Storage phase –Actively relaxes to store urine. –Majority of time spent in this phase. Emptying phase –Coordinated sphincter relaxation and bladder contraction.

4. A Spectrum of Symptoms z FrequencyFrequency UrgencyUrgency StressIncont. MixedIncont. Urge Incont. Overactive Bladder Minimally Invasive Surgery Incontinence Medications & Neuromodulation

5. What is Overactive Bladder (OAB)? –Defined as a compelling desire to void that is difficult to deter. >8 times per day, >2 times per night –A third of the patients with OAB will also have urge urinary incontinence. –Absence of urinary tract infection or neurological condition (Multiple Sclerosis, Parkinson’s Disease).

6. Prevalence of OAB increases with age Men Women N = 5,204 0510152025303540 18-24 25-34 35-44 45-54 55-64 65-74 75+ Age (years) Prevalence (%) Prevalence of OAB in the United States: Estimated to Impact ~33 Million Americans National Center for Health Statistics. Vital Health Stat. 2002;10:209. Stewart W et al. World J Urol. 2003;20:327-336.

7. Diagnostic Evaluation Medical History –Hematuria, pelvic surgery or radiation, infections Physical Exam –Office cystoscopy to exclude malignancy or stones. Office tests –Urine Analysis, post void residual urine assessment, Uro-flow and PSA (in men) –Urodynamic testing A 48 hour Voiding Diary Questionnaire

8. Treatment Options for OAB Dietary –Reducing bladder irritants such as caffeine, alcohol, nicotine. Behavioral Modification –Review of the Voiding Diary, biofeedback. Pharmacotherapy: anticholinergics –Ditropan, Detrol, Enablex, Sanctura, Vesicare. Minimally Invasive Treatments –Botox –Neuromodulation (InterStim)

9. Medicines: Anticholinergics Heavily marketed medicines –Detrol –Vesicare –Enablex –Sanctura –Oxytrol –Ditropan These medicines help relax the bladder. They work by blocking receptors in the bladder.

10. Adverse Reactions to Medications Dry mouth or eyes (20%-45%) Constipation (6%-21%) Headache (4%-8%)

11. Drug Therapy Persistence is Poor Among OAB Patients 20% 40% 60% 80% 100% Prescription persistency rates of OAB medications among patients new to market (n=21,362) Source: The 2002 Gallup Study of the Market for Prescription Incontinence Medication. Princeton, NJ: Multi-Sponsor Surveys, Inc 2002 This data is dated from 2002 and current numbers would likely be better, but only marginally.

12. InterStim Therapy for Urinary Control FDA-approved treatment for urinary control problems in people who have not had success with behavioral modification or medications. Over 30,000 patients implanted worldwide

13. Test Stimulation A test is done to determine the respond to the stimulus. Performed in the office (20 minutes). A lead is placed under the skin just above the tailbone Lead is connected to an external device (size of a pager) for a period of 2-3 days. The decision for implantation of the permanent device will be made based on the response to the test stimulation

14. Implantation of the InterStim System Procedure done in operating room using a light anesthesia on a same day surgery basis. Stimulator is usually placed in upper buttock The entire InterStim System will reside under the skin Entire procedure takes less than one hour

15. How effective is this therapy? Urge Incontinence 45% of patients completely dry Further 34% had 50% or greater reduction in symptoms Urgency-Frequency 31% back to normal (4-7 per day) Additional 33% had a 50% or more reduction in number of urinations Retention 61% stopped catherization 16% had > 50% reduction in the amount of urine emptied from the bladder by catheter Results 12 Months After Surgery Medtronic clinical study data on file

16. Potential Risks with InterStim Therapy As with other surgical procedures, there are risks: –Pain –Infection –Transient electrical shock –Lead migration These complications were generally resolvable in the clinical study

17. Does insurance pay for this? National Medicare coverage policy. Local coverage in the Twin Cities is excellent.

18. Pearls Trans-obturator taping for stress incontinence: –Highly effective, same day surgery. InterStim for frequency and urge incontinence: –Office procedure, well tolerated. Medications are rarely the cure for incontinence. Careful evaluation for an accurate diagnosis –Voiding diary, urodynamics.

19. Thank You Chase Kenyon Sovell, MD Urology Associates, Ltd (952) 925-0473