1. Use of Sacral Neuromodulation in the Management of Voiding Dysfunction
Sacral Nerve Stimulation (SNS) is a therapy used to treat voiding dysfunctions. The FDA approved sacral nerve stimulation\InterStim Therapy for urinary urge incontinence, urgency-frequency and urinary retention. This therapy uses an implantable system that includes a internal battery (neurostimulator, INS) and lead to deliver mild electrical stimulation to the sacral nerves that influence the bladder, sphincter and pelvic floor muscles. At this time, 85,000 implants have been completed worldwide.
Developed by the
SUNA Sacral Nerve Stimulation Special Interest Group Revised Oct 2010

2. InterStim Therapy Cumulative Use World-wide
20000
40000
60000
80000
100000
1998
2000
2002
2004
2006
2008
2010
InterStim Therapy Cumulative Use World-wide
Technique Change – 2002
Percutaneous Tined Lead Placement
Department of Urology, University of California at San Francisco initiated clinical program.
Multi-center trial conducted by Urosystems, Inc.
Medtronic CE mark (approval to market in Europe) for InterStim® in Europe for treatment of Pelvic Floor Disorders (Urinary and Bowel Control)
FDA grants Medtronic approval of the InterStim System for treatment of urge incontinence in the US.
FDA approval of the InterStim System for symptoms of urinary urgency-frequency and urinary retention.
Significant technique change – percutaneous lead placement
Today –Over 85,000 implants performed worldwide.
More than 85,000 patients have received InterStim Therapy

3. Program Goal
To discuss the prevalence & treatment of urinary control problems and the use of sacral neuromodulation as a treatment option for patients with urinary urgency-frequency, urinary urge incontinence and/or urinary retention who fail or cannot tolerate conservative treatments.
Our goals for this presentation are to discuss prevalence and treatment for voiding dysfunctions, including sacral nerve stimulation as a treatment of choice for the patient who has failed one or more of the conservative treatments.

4. Learning Objectives:
After completing this program you will be able to:
Discuss the prevalence of urinary urgency-frequency, urinary urge incontinence and/or urinary retention.
Define sacral nerve stimulation (SNS)
Discuss the treatment algorithm used to treat urinary urgency-frequency, urge incontinence and retention.
Discuss the theory of mechanism of action of sacral nerve stimulation.
Explain the basic steps for the test stimulation and implant procedures used for InterStim Therapy
Identify the implantable and external equipment used for sacral nerve stimulation.
State the FDA approved indications for SNS.
Identify patients appropriate for SNS when provided a case scenarios.
Our objectives for this presentation is to
Discuss the prevalence of urinary urgency-frequency, urinary urge incontinence and/or urinary retention.
Describe sacral nerve stimulation (SNS)
Discuss specific treatment algorithm used to treat urinary urgency-frequency, urge incontinence and retention.
Discuss the mechanism of action theory associated with sacral nerve stimulation.
Describe the basic steps for the test stimulation and implant procedures.
Name the implantable and external equipment used for sacral nerve stimulation.
Discuss the FDA approved indications for InterStim Therapy.
Identify patients appropriate for InterStim Therapy and go over a case scenario using the outline we have described in the presentation.

5. Voiding Dysfunction: A Hidden Problem
Patients are embarrassed to talk to healthcare providers about voiding problems
Many providers typically do not ask patients about voiding problems
Quality of life issues can include:
Anxiety, depression, infections,
nocturia, odors, embarrassment,
diet restrictions, discomfort / pain,
limitations of social activities and
employment opportunities,
and cost of protective garments
Voiding dysfunction is major health care issue. The first series of slides cover voiding dysfunction and patient concerns. Other slides will cover normal and abnormal voiding and the prevalence of voiding dysfunction in the US population.
Health Care providers believe voiding dysfunction is a hidden problem. Patients are embarrassed to discuss or start a conversation about incontinence or voiding dysfunction with their healthcare providers. Today it is the responsibility of the provider to ask specific questions about these issues. While hidden, voiding problems have a huge impact on a person’s quality of life. Patients will likely exhibit anxiety and/or depression. They may be treated for frequent urinary tract infections. In addition, patients will complain about odors and express feelings of embarrassment. Patients will actually restrict their diet and change their drinking habits. They will limit their social activities and because of their incontinence/smell may have limited employment opportunities. Patients will complain about the rising cost associated with protective garments. It is estimated that 62 billion dollars is spent a year on care associated with incontinence such as under garments skin break down associated with incontinence.

6. Normal Micturition Requires coordinated activity between the
Afferent
Efferent
Requires coordinated
activity between the
nerves and the muscles
that control voiding
Normal micturition (voiding) relies on controlled storage and release by the precise coordination of detrusor and pelvic floor muscles. The bladder is usually in “off” mode. The bladder fills and empties, reflected in two separate phases, the filling stage and the emptying stage.

7. Filling Phase Automatic Actions: Conscious Actions:
Brain signals detrusor muscle to relax
to allow urine to fill bladder
Once bladder fills to capacity, bladder
nerves signal fullness back to brain
Conscious Actions:
As bladder fills, you become aware of
fullness
- The response is to void or wait for a opportunity to void.
Both the filling and emptying phases exhibit automatic and conscious actions. The automatic action of the filling stage is when the brain signals the detrusor muscle to relax and allows urine to fill the bladder; once the bladder fills the sacral nerves send a signal back to the brain saying the bladder is full. Once the bladder fills, one becomes aware of the fullness and responds, there is a voluntarily contraction of the external sphincter and the person will void or wait until there is a more opportune time to void.

8. Emptying Phase Automatic Actions: Conscious Action:
Voiding reflex occurs
Nerves in spinal cord signal detrusor
muscles to contract and internal
sphincter to relax to allow urine to
flow from bladder into urethra
Conscious Action:
Once urine enters urethra, you
consciously relax the external sphincter
to allow urine to pass through the urethra
The automatic action associated with the emptying phase begins with a voiding reflex. With the voiding reflex, nerves in the spinal cord signal the detrusor muscles to contract, then the internal sphincter says relax allowing the urine to flow from the bladder into the urethra. Once the urine enters the urethra, you consciously relax the external sphincter to allow the urine to pass through the urethra.

9. Abnormal Micturition
Voiding dysfunction occurs when a patient’s normal micturition reflexes are altered because of a neurological disease, infection, inflammation, or anatomical abnormalities in voluntary voiding reflexes.
The majority of the population has normal voiding patterns with filling and emptying phases. Patients with voiding dysfunction will have altered micturition reflexes associated with neurological disease, infection, inflammation or anatomical abnormalities affecting the voluntary voiding reflexes.

10. Urinary Urgency-frequency and Urinary Urge Incontinence
US prevalence = 33.3 million1
16.5% of US population1
1. Stewart WF, et al. Prevalence and burden of overactive bladder in the United States. World J Urol. 2003:20:
2. Garnett S, et al. The natural history of overactive bladder and detrusor overactivity: a review of evidence regarding the long-term outcome of the overactive bladder. J Urol. 2003;169:843.
3. Haab F, et al. Persistence with antimuscarinic therapy in patients with overactive bladder. Int J Clin Pract. 2005;59(8): Ziment Market Research 2005.
4. Medtronic Market Research 1998
7.3 million
30% actively seeking care (excluding men w/BPH ~8.0 million)2
Women: 2.9 million
Men: million
Patients who cannot tolerate pharmacotherapy (~55%)
4.0 million3
Women: 2.0 million
Men: million
Patients with continued symptoms actively seeking further treatment (~70%)4 2.8 million
Total: million
Women: million
Men: million
This is a busy slide but discusses the prevalence of patients who suffer from urinary urgency-frequency or urinary urge incontinence in the US about 30 percent actively seeks treatment for their condition. Aside from men with benign prostatic hyperplasia (BPH) approximately 7.3 million urinary urgency-frequency or urinary urge incontinence patients actively seek care. Of patients seeking care and receiving medications for urinary urgency-frequency or urinary urge incontinence, approximately 55 percent do not tolerate prescribed therapy. 70 percent of this group will seek further treatment, such as InterStim Therapy. Of those patients, some may have co-morbidities or economic barriers that would exclude them from having sacral nerve stimulation as a therapeutic option. The remaining patients represent approximately 1.8 million individuals for whom InterStim Therapy is a viable treatment option.
Potential patient candidates for SNS† (~65%)*
Net 1.8 million
* Assuming clinical exclusion of 20% & economic exclusion of 15%

11. Sacral Nerve Stimulation (SNS)
Overview
Sacral Nerve Stimulation (SNS)
The next series of slides will provide an introduction and overview of Sacral Nerve Stimulation the therapy.

12. SNS - Therapy Definition: Indications:
An implantable system that stimulates the sacral nerves modulating the neural reflexes that influence the bladder, sphincter, and pelvic floor.
Indications:
SNS is used to treat urinary retention and the symptoms of overactive bladder (OAB), including urinary urge incontinence and significant symptoms of urgency-frequency in patients who have failed or could not tolerate more conservative therapies.
Sacral nerve stimulation utilizes an implantable system that stimulates the sacral nerves modulating the neural reflexes that influence the bladder, sphincter and the pelvic floor. There are specific FDA approved indications for the use of sacral nerve stimulation therapy, such as non-obstructive urinary retention urinary retention and the symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency frequency in patients who have failed or can not tolerate more conservative therapies.

13. SNS - Therapy
SNS utilizes mild electrical pulses to simulate the nerves associated with voiding function. Neurostimulation may significantly improve normal voiding function.
Sacral nerve stimulation utilizes mild electrical pulses to stimulate the nerves associated with voiding function. For appropriately selected patients, neurostimulation will significantly improve or return dysfunctional voiding to a normal voiding pattern. Patients describe the sensation from the stimulation as an impulse that feels like a tapping, flutter or tingling sensation in the vagina or penis, perineum or rectal area. If the patient’s symptoms are well controlled the system is working and will not need adjustments. If the patient’s symptoms return they may need to be reprogrammed or seen by the provider.

14. SNS Theory of Mechanism
Urge incontinence: Modulation enables more
normal detrusor muscle
behavior
Urgency-frequency: Modulation helps reduce
detrusor and pelvic floor
muscle spasticity
The theory associated with the mechanism of this modulation, if the patient has urge incontinence this modulation will improve detrusor muscle behavior. If the patient was diagnosed with urgency frequency sacral nerve modulation will reduce detrusor and pelvic floor muscle spasticity.

15. Pharmacotherapy vs. SNS Therapy
Pharmacotherapy: Mechanism of Action
SNS Therapy: Mechanism of Action
Targets efferent effects
Poor patient compliance related to the side effects (i.e. dry mouth)
Targets afferent effects & modulation of the pelvic floor
General lack of side effects known associated with drug therapy
There is a difference between the mechanism of action of pharmacotherapy and sacral nerve stimulation\InterStim Therapy. This slide explains the difference between the two. Medications will target the efferent effects. There is poor patient compliance with medications because of the side effects associated with drugs. Sacral nerve stimulation\InterStim Therapy targets the afferent effects and causes modulation of the pelvic floor; this therapy is well tolerated and lacks the side effects associated with drug therapy. Keep in mind that sacral nerve stimulation\InterStim Therapy should be considered after more than one conservative treatment option have failed.
InterStim Therapy
Should be considered after more conservative treatment options have failed and before surgical options are considered

16. Clinical Results: 5-Year Efficacy
Purpose
This post-approval, non-randomized, multicenter study provided data on the long-term effects of sacral nerve stimulation for the treatment of urinary urge incontinence, urinary urgency-frequency, and urinary retention in patients who had failed or could not tolerate more conservative treatments. The study took place at 17 centers in the United States, Canada, and Europe.
Results
The study demonstrated that InterStim Therapy can be a long-term solution for patients with overactive bladder or non-obstructive urinary retention.  Based on the subset of study subjects for whom both baseline and five-year data were available (i.e., the evaluable sample), improvement ranged from 39% to 78%, depending on the outcome assessed.  If all implanted study subjects are considered (i.e., the intent-to-treat sample) and missing five-year data are imputed using baseline values (or, in the absence of baseline values, from the mean baseline of all subjects with baseline values), the results range from 28% to 58%, depending on the outcome assessed. 
See InterStim Therapy Clinical Summary for complete details.
Data from Medtronic post-approval Study.

17. 5-Year Clinical Efficacy Urge Incontinence – 60 month post-implant results
Intent to Treat Patients – defined as all implanted study subjects, including those who dropped out and were imputed as no change from baseline.
Intent to Treat
Evaluable Patients
71%
59%
42%
Patients %
37%
Evaluable Patients – defined as the subset of subjects for whom both baseline and 5-year data were available.
The Medtronic 5 year clinical efficacy is reported using 2 different analysis methods.
Intent to Treat Patients – defined as all implanted study subjects, including those who dropped out and were imputed as no change from baseline.
Evaluable Patients – defined as the subset of subjects for whom both baseline and 5-year data were available.
n = 96
n = 84
n = 61
n = 49
≥ 50% Reduction in Leaks/Day
≥ 50% Reduction in Heavy Leaks/Day1
1 Excludes patients who reported no heavy leaks at baseline and at 60 months post-implant

18. 5-Year Clinical Efficacy Urge Frequency – 60 month post-implant results
Evaluable Patient
Intent to Treat
56%
56%
40%
40%
39%
Patients %
28%
The Medtronic 5 year clinical efficacy is reported using 2 different analysis methods.
Intent to Treat Patients – defined as all implanted study subjects, including those who dropped out and were imputed as no change from baseline.
Evaluable Patients – defined as the subset of subjects for whom both baseline and 5-year data were available.
n = 25
n = 25
n = 25
n = 18
n = 18
n = 18
≥ 50% Reduction in Voids/Day
≥ 50% Increase in Volume Voided/Void
≥ Improved Degree of Urgency Prior to Void

19. 5-Year Clinical Efficacy Urinary Retention – 60 month post-implant results
Evaluable Patient
Intent to Treat
78%
65%
58%
48%
Patients %
The Medtronic 5 year clinical efficacy is reported using 2 different analysis methods.
Intent to Treat Patients – defined as all implanted study subjects, including those who dropped out and were imputed as no change from baseline.
Evaluable Patients – defined as the subset of subjects for whom both baseline and 5-year data were available.
n = 31
n = 31
n = 23
n = 23
≥ 50% Reduction in Catheterizations/Day
≥ 50% Reduction in Volume/Catheterizations

20. Patient Selection/Cases
Factors influencing Patient Selection
Who is a candidate for sacral nerve stimulation? The following slides cover the algorithms that have been developed to assist providers in choosing the appropriate candidates for InterStim Therapy.

21. Behavioral Techniques Interventional Techniques
Treatment Algorithm For Urinary Urgency-frequency and/or Urinary Urge Incontinence
Initial Screening
Voiding Diary
Urodynamic
Workup
Behavioral Techniques
Interventional Techniques
Medications
Continue as
Appropriate
SNS
Test Stimulation + -
This algorithm relates to patients with urinary urgency-frequency or urinary urge incontinence. It is essential to begin with a complete history and physical. Review behavioral techniques, including diet, pelvic floor rehabilitation (biofeedback, e-stim) and determine what has or has not worked. Review medications the patient has used and trial other medications if needed. Common medications include anticholinergics, Elmiron, antihistamines, muscles relaxants, and ICFS. The evaluation should also include information to rule out ISD and stress incontinence. Schedule the patient for a urodynamic study and a cystoscopy (may use cystoscopy with hydro distension for urgency-frequency). Have the patient complete a voiding diary. It should be completed 3 days before the InterStim Therapy test and three days during the test.

22. Retention Treatment Algorithm
Initial Screening
Voiding Diary
Urodynamic
Workup
Rule Out Obstruction
Continue as
Appropriate
SNS
Test Stimulation + -
Medications and/or
Catheterization
There is an algorithm for non-obstructive urinary retention. Using this algorithm, the patients evaluation includes a magnetic resonance imaging (MRI) to rule out disc disease, spinal cord tumor, or other spinal column abnormality. The patient should first try an alpha-blocker to see if it will stimulate a voiding reflex. A voiding diary is essential as it will be used as a baseline to see the frequency and volumes of catheterizations. A urodynamic test is also done to make sure there is no blockage and that there is bladder activity (not flaccid). The physician will also do a cystoscopy to rule out other underlying diseases. Once the tests are completed, and the physician determines the patient is a potential candidate, the patient and physician can make an informed decision about whether to do an InterStim Therapy test stimulation procedure.

23. Other Issues Influencing Patient Selection
Mental status
Psychiatric status
Patient expectations
Multiple Sclerosis
Back or neurological problems
Support system
Discussion of alternative treatment
Issues that contribute to SNS failure
There are several other issues that can influence patient selection. The patient’s mental and psychiatric status can impact decision making and complicate the test. Patient expectations and desires should be considered--it is important that the provider discuss expectations in the very beginning and decide together what the test means to this patient. Patients with multiple sclerosis should be counseled before they consider SNS and if they will need frequent MRI they should not be considered as a candidate for this procedure. Any back or neurological problems may impact the test and enhance or decrease symptom relief impacting the test and outcome. Most patient with a significant support system do better--friends or family are more likely to provide a positive influence and help them though the test and surgery. Alternative treatments and behavior modifications should be tried before deciding to trial sacral nerve stimulation. Diet modifications such as reduction and/or elimination of caffeine, artificial sweeteners, and highly acid foods and beverages should be tried first. Patients should also try pelvic floor therapy with a physical therapist and/or biofeedback— with these treatments, the provider should educate the patient and evaluate whether or not the patient can relax and tense pelvic floor muscles. Medications are often used in conjunction with other treatment modalities. InterStim Therapy is used when conservative therapies are ineffective or poorly tolerated. Patients who have severe bladder disease may not get better. Some patients with small bladders may continue to have frequency if the bladder is non-compliant. It is certainly worth a try to test patients with chronic health problems or with psychological problems, but realize that the test may not be successful due to their other problems. One very important factor regarding the SNS test and implantation is the patient expectations. If a patient expects to be 100% better, anything less than 100% will be unsuccessful. Expectations should be discussed when first introducing the therapy to the patient, during additional visits prior to the test procedure, and when the test and implant procedures are done.

24. 1st Phase testing/PNE 2nd stage Implant when to program
Overview
1st Phase testing/PNE 2nd stage Implant when to program
The next several slides discuss the surgical procedure and patient programming.

25. Test & Implant Procedures
1st Phase: Test stimulation
Test can be done with a temporary or chronic lead
2nd stage Implant
The implanted portion of the InterStim System includes a lead placed in the S3 sacral nerve attached to a programmable battery (neurostimulator, INS). The test and implant are completed in two separate stages.
The first stage is the test that allows the physician and patient determine if SNS will be an effective therapy. It may last from 3-7 days and can be done as a percutaneous test in the clinic or a chronic lead is placed in the operating room.
The percutaneous test (PNE) is when a temporary lead is placed in the sacrum as a outpatient procedure in a clinic using local anesthesia—flouroscopy is recommended and used to assist with lead placement. The test procedure is a minimally invasive, low-cost method of assessing the integrity of the sacral nerves.
When a chronic lead is used for the test, the procedure is completed in a surgical outpatient clinic--this tined lead is placed for the test if this test is successful this tined lead will ultimately be used for the implant. Even though this procedure is completed in a outpatient surgical setting it is considered minimally invasive.
Temporary Lead
Chronic Lead

26. Test \PNE Test stimulation:
Is done to determine how the patient will respond to the implanted device
Is an outpatient procedure performed in the office or OR depending upon the lead used (temporary in office/chronic in OR)
Lead is placed under the skin through the S-3 foramen in close proximity to the S-3 nerve
Lead is connected to an external device worn on belt for a period of 3-7 days
The decision for implantation of the permanent device is made based on response to the test stimulation
The test is used to determine if the patient will experience relief of their urinary symptoms. Again, it is an outpatient procedure in the office (PNE) or the placement of tined lead in the operating room. The tined lead is placed under the skin through the S-3 foramen in close proximity to the sacral nerves. The lead is connected to an external stimulation device worn on a belt for a period of 3-7 days depending on the test. The decision for implantation is based on the patient diaries (objective data) and patient verbal responses (subjective data). The patient symptoms must be 50% or greater at the end of the test before they will be considered for implantation.

27. Voiding Diary Documentation
3 days of diaries before test and during test
Urge Incontinence
Number of leaking episodes per day
Severity of leaking episodes per day
Number of pads/diapers per day
Urgency-frequency
Number of voids per day
Volume of voids per day
Degree of urgency
Retention
Catheterized volume vs voided volume
Number of catheterizations per day vs number of voids per day
Each patient should complete a three-day diary before the test and during the test. The objective data in the diary along with the patient’s verbal (subjective) information will help the physician determine whether or not the test is successful. This slide shows the diary and recording depending on their diagnosis, the diary should be reviewed by the health care provider before and after the test. The provider would expect a patient with urge incontinence to show a decrease in leaking episodes; the severity of leaks; and, the number of pads or diapers used per day. If a patient has urgency-frequency, the provider should see a decrease in the number of voids per day and changes in the degree of urgency. If the patient has retention, the provider would expect to see a decrease in the catheterized volumes and number of catheterizations per day.

28. Test & Procedures 2nd stage
2nd Phase: Chronic Implant
If tested with temporary lead: Implantation of neurostimulator (INS) and lead and/or extension (if necessary)*
If tested with chronic lead: Implantation of neurostimulator (INS)
If a successful 3-7 day test was done using a temporary lead (PNE), this temporary lead is removed in the office/clinic and a lead and INS will be implated together at a later date. If it is a chronic lead is successful the lead will not be removed and a neurostimulator (INS) will be connected to the lead and placed in a pocket in the upper buttock.
Occassional if the test (PNE) was not successful a stage procedure can be done using a chronic lead.
* Components requiring implantation depend on the selected InterStim neurostimulator used for the implant.

29. 2nd Stage Implant Procedure 2nd Stage:
Outpatient procedure done in operating room using general or local anesthesia
Stimulator is implanted and connected to a lead that will stimulate the sacral nerve
Stimulator is usually placed in upper buttock
The entire implantable System resides under the skin
Entire procedure takes minutes
The second stage is completed in an outpatient setting using local and/or monitored anesthesia care (MAC sedation) or general anesthesia. If a chronic lead was used for the test procedure, the neurostimulator (INS/battery) will be connected to this lead and placed in a pocket in the upper buttock. At the end of the 2nd stage the entire interstim system will be under the patients skin. If the patient had the PNE the entire system would be placed under the patients skin during this procedure. Once the battery is placed and the patient is in the recovery area a clinician familiar with programming will program the device. This stage takes about minutes. Note: If the test with the chronic lead was not successful, the lead will be removed and the physician will discuss other therapy options with the patient.
The components used with the SNS. On the right is the larger battery called the InterStim INS and on the left is the smaller battery called the InterStim II INS. The tined lead is attached to the InterStim II INS. There are two patient programmers the one shown here is the InterStim iCon™ Patient Programmer Model this programmer supports both the InterStim and InterStim II INS devices. The other component is a clinician programmer which is used by clinicians to program the INS.

30. System Implantation: Connect implanted Lead to INS
Create a subcutaneous pocket
Tunnel the implanted lead to the pocket site
The implanted lead, extension (if required), and INS are connected and placed in the pocket.
Verify system integrity (no short or open circuit), then close the pocket.
INS = Implantable Neuro Stimulator

31. Benefits of SNS Potential Adverse Events
Test stimulation period allows informed choice for patient and doctor
Effective treatment in properly screened patients
Safe
Reversible
Does not preclude use of alternative treatments
Potential risks, pain at neurostimulator site, infection transient electric shock
There are advantages for this therapy. First the patients are allowed to “test drive” the therapy—during this time they will learn what the therapy feels like and how their symptoms are controlled. The patient has an opportunity to decide if the therapy meets their expectations. A patient would expect to see symptoms change in the 3-7 days. This therapy is safe and reversible and does not preclude the use of alternative treatments.
There are few adverse events to this therapy, they include pain at the battery site (called pocket pain) or at the lead site. There is always the potential for infection--if a lead site becomes infected, the lead will be removed. If the therapy was successful, the lead can be replaced after the infection is treated. If a lead cracks or breaks some patients may experience mild transient electric shocks. A broken lead may or may not need to be removed—if some of the lead wires are still intact, a clinician may be able to reprogram the INS. If the lead cannot be reprogrammed, it will need to be removed. The patient can experience change in bowel function including diarrhea or constipation. Some patients experience improved bowel function and have a normal bowel pattern which can be considered a secondary gain.

32. When Do You Program?
After initial implantable neurostimulator (INS) implantation:
Day of surgery—1 week (physician preference)
Patient’s system requires “reprogramming”:
Symptoms reappear
Discomfort
Loss of stimulation
A clinician will start the programming on the day of surgery or within a few days depending on the physician’s preference. A patient may call for a readjustment when their symptoms reappear; when there is discomfort; or when they cannot feel the sensation and symptoms change. It is important to remember that patient symptoms may return and it may not be related to the sacral nerve stimulator but another cause such a urinary tract infection [UTI], or diabetes. Be sure to check for other possibilities before beginning the reprogramming.

33. Case Studies Retention with frequency-urgency
This presentation has one case study on a patient diagnosed with retention and urgency-frequency.

34. History
65 y/o wf with retention, frequency, urgency and voiding dysfunction. Strains to void in addition to doing CIC and spontaneous voiding
Leaking in between CIC
Small cystocele noted
This is a 65 year old white female with retention, urinary frequency-urgency and strains to void. She has been performing CIC (intermittent catheterization) every four hours using clean technique and voids spontaneously with leaking in between doing CIC. She is wearing pads daily due to the incontinence she is experiencing. The physician noted a small cystocele upon exam, most likely due to her straining to void.

35. Voiding Diary Pt voids 2-4 oz q 2-3 hrs
Pt caths 3 x day (ave. = cc)
Leaking in between cathing
Wears 3-4 pads per day
Her diary reveals she has obvious frequency with small volumes that average 2-4 oz every 2-3 hours. She catheterizes 3 times a day for an average output of cc and she leaks in between catheterizations causing her to wear 3-4 pads per day. The voiding diary is vital tool in evaluation of this patient. Knowing her baseline prior to a SNS test is essential. A diary reveals volumes the patient is able to hold; how much fluid she takes in; how often she voids, leaks, or wakes up to void; the number of pads used during the day and night, etc.

36. Cystoscopy Normal urethra, bladder and ureters
Normal pelvic exam and female genitalia
No edema, lesions or palpable abnormalities
Anterior and apical compartments are well supported
Most patients undergo a cystoscopy initially to evaluate the bladder lining integrity as well as urethra and sphincter compliance. A urodynamic study is usually followed if etiology of the problem is not obvious. This particular patient’s cystoscopy shows no underlying problems with no obvious abnormalities. At this point a physician may chose to use anticholinergic’s if none have been tried. With a neurogenic bladder component, obstruction needs to be ruled out. For this reason, a Video Urodynamic study was ordered by this particular physician in order to observe the bladder under fluoroscopy imaging.

37. Strains to Void
Video urodynamics was unable to demonstrate any leak point pressures using the Valsalva maneuver as sometimes is the case due to the pts inability to relax during a Urodynamic study or the cystocele may be obstructing the bladder neck. This patient’s cystocele was not worth reducing as it was less than a grade 1 and non-obstructing the urethra upon exam. However, leakage is clearly noted in the patients voiding diary, most likely due to urge/stress incontinence. In order to compensate for the lack of detrusor pressure during the voiding phase, the patient resolves to strain voiding thus creating leakage to occur whenever the pt creates stress and the bladder is full with urine. Examples of this would be lifting, coughing, sneezing and laughing. So, what is obvious about this study is the patient is straining to void when she reaches, “Maximum Capacity”, and she strains in order to generate pressure to get the urine out. She demonstrates during the voiding phase of this study how much pressure she generates on the Pabd and Pves channels (note the blue arrow). Both of these channels detect her obvious pelvic straining verses relaxing to void. The patient was infused with 579cc of contrast and she was able to strain out 413cc with a remaining PVR of 167cc. She normally performs CIC to remove the remaining post void residual (PVR). No detrusor pressures are able to be detected during the voiding phase due to the patients habit of staining to void. Bladder outlet obstruction is ruled out. The first channel labeled, “flow”, reveals an intermittent flow which is common with patients who strain void. This wound be a good place to stress how Urodynamics is used to rule out obstruction. Remember, bladder outlet obstruction may be caused from enlarged prostate, dysynergia, or pelvic organ prolapse. Common examples for obstruction are low flow rates with elevated voiding pressures and possible detrusor over activity or low compliance. Bladder contractions usually begins way before the voiding has actually started and while the contraction being measured to void is usually sufficient the flow is usually low and prolonged.
Normal Values for Uroflowmetry
Males Females
<40 yrs old >22 ml/sec <50 yrs old >25 ml/sec
40-60 yrs old >19 ml/sec >50 yrs old >18 ml/sec
>60 yrs old >13 ml/sec
Source: Walsh et al., 2002
The video urodynamics test was unable to demonstrate any leak point pressures using the Valsalva maneuver. This sometimes occurs due to the patients’s inability to relax during a urodynamic study—or the cystocele may be obstructing the bladder neck. This patient’s cystocele was not worth reducing as it was less than a grade 11 and not obstructing the urethra upon exam. However, leakage is clearly noted in the patients voiding diary, most likely due to urge/stress incontinence. In order to compensate for the lack of detrusor pressure during the voiding phase, the patient continues to strain while voiding.
Leakage can occur whenever the patient creates stress when the bladder is full. Examples of this would be lifting, coughing, sneezing and laughing. So, what is obvious about this study is that the patient is straining to void when she reaches, “Maximum Capacity”, and she strains in order to generate pressure to get the urine out. She demonstrates during the voiding phase of this study how much pressure she generates on the Pabd and Pves channels (note the blue arrow). Both of these channels detect her obvious pelvic straining verses relaxing to void. The patient was infused with 579cc of contrast and she was able to strain out 413cc with a remaining PVR of 167cc. She normally performs CIC to remove the remaining post void residual (PVR). No detrusor pressures were detected during the voiding phase due to the patients habit of straining to void. Bladder outlet obstruction is ruled out.
The first channel labeled, “flow”, reveals an intermittent flow which is common with patients who strain to void. Urodynamics is an essential tool to use to rule out obstruction. Remember, bladder outlet obstruction may be caused from enlarged prostate, dysynergia, or pelvic organ prolapse. Common examples for obstruction are low flow rates with elevated voiding pressures and possible detrusor overactivity or low compliance. Bladder contractions usually begins way before the voiding has actually started and while the contraction being measured to void is usually sufficient the flow is usually low and prolonged.

38. Video Urodynamics
The small cystocele is not worth reducing during the Video Urodynamic study because it is less than a Grade 1 and not obstructing the urethra while voiding. The bladder neck is clearly wide open during the voiding phase while pt is straining to void. This particular picture of the pt’s bladder is taken under fluoroscopy in between straining to void.

39. Urodynamic Results
Normal storage parameters consisting of nl sensation/compliance and capacity
No Detrusor overactivity
No SUI
Abnormal voiding (strains to void)
No evidence for outlet obstruction
The results of her urodynamic’s study reveals that she has normal storage and sensation with no detrusor over activity. SUI was unable to be reproduced. During the voiding phase of her study she has abnormal voiding due to straining but no evidence of outlet obstruction is detected.

40. Recommendations and Results
SNS Test
Voids 4-5 times a day and emptying (cathing less than 50cc)
No leaking in between cathing
Pt implanted 3 wks later
Since she had already tried ACH medications in the past with no results, an InterStim test was suggested to the patient. After her urodynamics test, a DVD explaining InterStim Therapy was given to the patient to review. At the patient’s follow-up visit to the physician, the patient made the decision to have the temporary percutaneous test performed. The test period lasted 7 days—during this time the patient was followed up with phone calls by the UDS clinician to document her subjective results and trouble shoot any problems. The results were very successful as she demonstrated 50% improvement during the testing phase. She decreased her voids per day, pads per day and her CIC output volumes were less than 50cc compared to 200cc pre test diary. At times her diary revealed that she emptied completely. She no longer experienced any leaking between cathing as well. She was eventually able to stop doing CIC overtime. The leaking improved and she felt she had recovered her quality of life again. This patient moved forward with implantation of the INS three weeks later.

41. Post InterStim Implant
Doing extremely well and emptying with no need to perform CIC
PVR post implant in office 13cc
Continues spontaneous voiding
Reports occasional twitching of her toe
F/U 1 yr or PRN-per clinic protocol
This patient is doing extremely well at her one year follow up visit. She continues to empty her bladder and no longer performs CIC. Her post void residual in the office was 13cc after spontaneous voiding and she does not have to push and strain so much anymore. The patient had undergone biofeedback prior to InterStim therapy which helped her to know how to relax during voiding. Her programming is satisfactory and she states she has some occasional twitching of her great toe but is able to decrease her amplitude using her patient programmer to resolve any issue of her toe without affecting results. She will follow up with her physician in one year to assess her symptom relief and interrogate her sacral nerve stimulator or PRN as needed if symptoms return or stimulation changes with decrease in symptom relief.

42. Patient Care Management
Mention SNS to patients and family early in treatment to give them an opportunity to adjust to the idea of an implanted device give them encouragement that there are alternative treatments if conventional therapy fails.
Perform thorough patient workup and correct any mixed incontinence issues or obstructive uropathy to give a SNS trial the best chance to succeed.
It is important to mention sacral nerve stimulation early in the patients treatment. This will allow the patient time to adjust to the idea. The clinician can start by having the patient watch the patient video and provide them with educational booklets on the therapy. A complete assessment/physical needs to be completed and the patient must have an approved diagnosis before the therapy is initiated.

43. Utilization of Multiple Modalities
To achieve optimal results for SNS patients may need:
to continue on or go on pharmacologic therapy
Continue dietary modifications
Continue or initiate pelvic floor rehabilitation
There are ways to optimize symptom control. Some patients will need to continue or go on medications to optimize the results. Patient should continue dietary modifications if necessary, and all patient should continue their pelvic floor exercises. If their symptoms continue other alternatives treatments should be considered.

44. Patient/Family Considerations
Provide realistic expectations of sacral nerve simulation so that everyone clearly understands that it is to help, not necessarily cure, their urinary problem.
Assist patients to recognize their role in achieving optimal urinary functioning and maintaining integrity of SNS.
We have discussed several times the importance of providing realistic expectations, the patient must clearly understand their symptoms should improve by 50% or more. Sacral nerve stimulation is not a cure but a device that will assist in achieving optimal urinary function.

45. Management of Care
Life choices that may affect system integrity and longevity
Impact on other chronic health problems or urinary status
Patients need to be counseled regarding the inability of having MRI once the SNS is placed
Patient responsibility to continue concomitant therapy, if recommended, and to use SNS as prescribed
Other considerations include the following: remember SNS is a lifetime choice that will assist with voiding dysfunction; make sure the therapy does not interfere with other chronic health care issues; patient need to be counseled from the beginning and understand they cannot have a MRI after the implant; and, remember that it is always possible that sacral nerve stimulation may not work 100% other concomitant therapies may need to be added to improve their symptoms.

46. Management of Care
Recognize there is a learning curve for surgeons to become proficient with lead placement.
Evaluate the patient as a whole at follow-up visits instead of automatically reprogramming SNS when the patient has complaints.
Utilize a consistent approach to patient management and programming issues to facilitate patient compliance and improve outcomes.
Be persistent.
We have provided limited information on programming. Patient follow up is essential and the care giver needs to recognize that programming is dependent upon careful placement of the leady by the physician. When the patient returns for follow up they should always be evaluated prior to reprogramming—other unrelated issues may cause symptoms to return. Always be consistent when programming and make sure they understand how to use their programmer. Remind the patient they need to bring their programmer to each appointment for reprogramming, this is an excellent time for the clinician to provide additional instructions, encouragement and support .

47. Summary
SNS is an effective treatment option for patients with non-obstructive urinary retention, urge incontinence or urgency/frequency, with or without IC
Consider SNS early in the treatment algorithm
Reinforce realistic expectations
Concomitant therapy may be needed with SNS to obtain optimal results
In summary sacral nerve stimulation is an effective treatment option for non-obstructive urinary retention, urge incontinence and/or urgency frequency. It should be considered when other treatments have failed. Once the patient has an implant other concomitant therapy, may be needed for optimal results. It is essential that realistic expectations be discussed and reinforced with each return visit. The patient should be reminded follow is essential and the battery should be checked yearly.

48. Educational Material Available
Patient Education Resources include:
Imagine Hope (brochure/DVD)
InterStim® Therapy Using Your iCon Programmer (DVD)
Clinician Resources include:
Decision Trees for Troubleshooting
Programming Basics Tutorial (online/DVD)
Patient Management Questionnaire
Patient Identification Tip Sheet
Patient Programming Work Sheet
Programming Pointers Guide
Reimbursement Information
Webb site for patients
Webb site for clinician
If you are just getting started Medtronic has patient and staff educational materials that would assist when working with Interstim patients. You can contact your representative who will help get the information you need.

49. Revision for SUNA Oct 2010 Lisa Zwiers, PA-C SIG leader 2010-2011
Helen Rittenmeyer BSN, RN
Pat Lee

50. SUNA Members 2008 Helen Rittenmeyer BSN, RN SIG leader 2007-8
Cindy Dobmeyer-Dittrich RN, BSN CURN
Vanessa Hardy NP, CURN
Debbie Hawe BSN, RN, CURN
Myra Gonzales RN
Pat Lee
Jacqueline Seacat RN, MSN, APN-BC, GNP, CUNP
Glenn Sulley BSN, RN, CURN
Patricia A. Young CNP, MSN, MEd, RNCA
Special thanks to Medtronic for allowing us to use their images and photos