Sacral Nerve Stimulation

Patient Profile

34-year-old female with urinary retention following bilateral ureteral reimplants. Married with 2 children, nonsmoker, light use of alcohol and caffeine. Complaints of urinary retention for 5 years. Performs intermittent self-catheterization 5 times daily. Minimal void amount with post-void residual (PVR) of 300 to 400 mL. History of frequent urinary tract infections due to self-catheterization.

Intervention Prior to Referral

Cystoscopy with bilateral retrogrades to exclude obstruction, which revealed mild bilateral hydronephrosis.

Unsuccessful interventions included:

• Trial of biofeedback
• Pelvic floor physiotherapy unsuccessful
• Suppressive Macrodantin^® (nitrofurantoin macrocrystals) 50 mg/day plus a trial of Flomax^® (tamsulosin hydrochloride) 0.4 mg nightly unsuccessful

ULTRAM^® (tramadol hydrochloride) and PYRIDIUM^® (phenazopyridine hydrochloride) prescribed for symptomatic urinary tract infections.

Physical Examination Prior to Implantation

Patient was referred in 2002 with retention and had been self-catheterizing for approximately 2 years.

Pelvic exam revealed that the following were normal: urethral meatus, urethra, bladder, uterus, cervix, and adnexa. Normal rectum, no rectocele. Perineal sensation intact. Voluntary rectal sphincter tone intact.

Urinalysis consistent with occasional white blood cells, possibly due to intermittent self-catheterization.

MRI shows a small L4-L5 disc protrusion without impression on the lumbosacral spinal canal and Intravenous Pyelogram (IVP) did show bilateral caliceal dilation. Videourodynamics study was performed revealing a peak flow of 9 and a mean of 5.

The patient voided 57 mL with a PVR of 225 mL. Filling desire was at 76 mL and urgency at 111 mL, which was the point that she developed vasovagal symptoms. A second fill revealed the same. Fluoroscopy did show significant trabeculation without reflux, and the bladder had a Christmas tree-like appearance.

Renal ultrasounds were performed approximately every 4 months to evaluate the kidneys. Results showed a simple cyst, thick-walled bladder, and right pyelocaliectasis, which were significant in the past.

Follow-up

Sacral nerve stimulation (InterStim^® Therapy) was first offered in 2002, but patient refused surgery at that time. By 2004, urgency and dysuria were increasing without relief from conventional treatment.

In 2005, she was given a patient video for the InterStim neurostimulator implantation and a patient question/answer sheet. Treatment options were discussed at length, including the risks and benefits of sacral nerve stimulation.

Patient Response to the Sacral Nerve Stimulation Test Procedure*

Patient underwent implantation and began showing improvement. After 4 days, she was able to decrease her self-catheterizing to twice daily with a PVR of 150 mL. Urgency disappeared. Subjective improvement was estimated at 95%.

Patient Response to the Sacral Nerve Stimulation Implant Procedure*

The InterStim neurostimulator was implanted 1 week after the test procedure. Intraoperatively, patient responded to 3 mA current with bellows and foot. Postoperatively, patient responded to 2 mA current.

At 3-month follow-up, patient reported that her residuals were less than 50 mA each day and she was able to stop daily self-catheterization. No adverse events were reported.

*Results may vary. Not all patients will experience the same results.

This case study recounts the experience of one patient receiving InterStim^® Therapy. Experiences are specific to this particular person. Results vary, and not every response is the same.

In addition to the risks related to any medical procedure, complications from this intervention can include: pain, infection, sensation of electrical shock, device problems, undesirable change in voiding function, and lead migration, among others.

Patient Profile

55-year-old female medical technician who competes in athletic events. Eight-year history of urge incontinence and urinary frequency. Symptoms interfered with her daily life and affected her ability to compete in races.

At the time of referral, patient was experiencing approximately 4 urge incontinence episodes/day and voided 15 to 20 times/day, all associated with significant urgency. Past medical history is remarkable for hypothyroidism and esophageal spasm.

Intervention Prior to Referral

Treated by primary care physician with oxybutynin 5 mg TID with some benefit.

Prior treatment also included:

• Detrol^® LA (tolterodine tartrate)
• Ditropan XL^® (oxybutynin chloride)
• Behavioral modifications (decreased intake of caffeine and spicy food)

After approximately 1 year of intervention, the patient developed severe gastroesophageal dysmotility that was unresponsive to medications.

Side effects improved with discontinuation of oxybutynin. Tolterodine caused similar symptoms and was discontinued.

Patient experienced severe dry mouth and eyes when using these medications.

Physical Examination Prior to Implantation

Physical examination failed to reveal any significant findings. Urinalysis was unremarkable.

Post-void residual with a bladder scanner was found to be negligible. Urodynamic evaluation showed a small capacity bladder (209 cc.) with poor compliance and multiple strong uninhibited contractions.

Emptying was complete with a poor Qmax of 9 cc Pelvic floor activity was appropriate.

Follow-Up

Patient and physician discussed treatment options that included continued medical treatment, biofeedback, intravesical BOTOX^® (botulinum toxin type A) injections, and sacral nerve stimulation (InterStim^® Therapy).

Patient opted for sacral nerve stimulation. Decision was based on the prior intolerance to medical treatment, probable lack of benefit with biofeedback, and the desire of the patient to undergo permanent intervention.

Patient Response to the Sacral Nerve Stimulation Test Procedure*

Patient underwent successful test of sacral nerve stimulation. There was approximately 70% improvement in her voiding frequency and urgency. There was also an approximately 50% improvement in her urge incontinence.

Intraoperative response: The patient had levator and toe responses in electrodes 1-3. Sensation was noted in the perineal area in all electrodes.

Patient Response to the Sacral Nerve Stimulation Implant Procedure*

Implantation of the InterStim neurostimulator was performed without difficulty. After 3 postoperative programming sessions, the patient experienced complete resolution of the urge incontinence and urinary frequency.

The number of voids decreased to between 6 and 7 per day. She didn't report any adverse events or complications following the implantation, and was able to resume her athletic events.

*Results may vary. Not all patients will experience the same results.

This case study recounts the experience of one patient receiving InterStim^® Therapy. Experiences are specific to this particular person. Results vary, and not every response is the same.

In addition to the risks related to any medical procedure, complications from this intervention can include: pain, infection, sensation of electrical shock, device problems, undesirable change in voiding function, and lead migration, among others.

Patient Profile

33-year-old female with refractory urinary urgency and frequency. 4-year history of urinary urgency, frequency, and pelvic pain. Voids 25 times per day, and 5 times per night. Complaints of decreased force of urinary stream. Often strains to void.

Bladder pressure worse during bladder filling, slightly improved with voiding. Concomitant conditions include endometriosis and gastroesophageal reflux. Has seen several clinicians, including 2 urologists and one urogynecologist.

Intervention Prior to Referral

Prescription of oxybutynin (25 mg/day) and Elmiron^® (pentosan polysulfate sodium) for 6 months led to slightly reduced voiding episodes of 20 per day and 4 per night.

Other interventions included:

• Weekly intravesical installations of DMSO for 6 weeks, which temporarily reduced voiding episodes to 18 per day
• VESIcare^® (solifenacin succinate, 10 mg) and Elavil^® (amitriptyline HCl, 10 mg) for 4 months (no change in symptoms)
• Over-the-counter _H2 blocker for gastroesophageal reflux

Diagnosed with endometriosis via laparoscopy by the urogynecologist. Patient takes no medication. Pelvic pain unimproved.

Physical Examination Prior to Implantation

Pelvic Examination

• No evidence of pelvic prolapsed
• Significant tenderness along anterior vaginal wall

Urinalysis and Cytology

• Trace microhematuria
• No malignant cells

Cystoscopy

• Numerous glomerulations at bladder base
• Bladder capacity 175 cc with pain upon filling

Urodynamics

• Sensory urgency
• Impaired relaxation of external urinary sphincter
• Maximum flow rate 11 cc/sec in a strain pattern
• Maximum detrusor pressure during voiding 40 cm H20

Renal and Bladder Ultrasound

• No evidence of renal masses or hydronephrosis

Clinical Evidence for Appropriateness of Sacral Nerve Stimulation

The patient suffered from classic refractory urgency and frequency that did not respond to traditional intervention with anticholinergics, pentosan polysulfate, and DMSO. The patient read a brochure about sacral nerve stimulation using the InterStim device and had all her questions answered prior to the procedure.

Patient Response to the Sacral Nerve Stimulation Test Procedure*

Within 2 days, urinary frequency was reduced to 12 times per day and nocturia was reduced to one episode. In addition, the force of urinary stream subjectively improved and pelvic pain subjectively improved by 50%.

Patient Response to the Sacral Nerve Stimulation Implant Procedure*

Implantation was performed 2 weeks after test procedure.

After InterStim implant procedure, the patient:

• Voids 10 times per day and 0-1 times per night
• Does not get up at night to void 50% of nights during the week
• Reports no adverse events
• Reports a 75% subjective overall improvement

*Results may vary. Not all patients will experience the same results.

This case study recounts the experience of one patient receiving InterStim^® Therapy. Experiences are specific to this particular person. Results vary, and not every response is the same.

In addition to the risks related to any medical procedure, complications from this intervention can include: pain, infection, sensation of electrical shock, device problems, undesirable change in voiding function, and lead migration, among others.

Patient Profile

37-year-old male with urinary urgency, frequency, and pelvic pain. Attorney, married with children, nonsmoker, no alcohol or caffeine use. History of migraine headaches and viral hepatitis.

A previous episode of acute prostatitis (10 years prior) responded to a single course of antibiotics.

No history of surgery, incontinence, hematuria, stone disease, or sexually transmitted diseases. No family history of genitourinary (GU) disease. No known drug allergies.

Patient was in acute distress with obvious strain on marriage and career.

Intervention Prior to Referral

Presented to primary care physician in September 2000 with prostatitis. Treated with a quinolone for more than 12 weeks.

When symptoms didn't respond to oral antibiotics, patient was admitted to the hospital and received IV gentamycin. Urologist performed a cystoscopy, revealing mild inflammation.

Patient started on Ditropan^® (oxybutynin) and amitriptyline, but continued to worsen with symptoms of low-back pain, suprapubic pain with bladder holding, voiding 25 times in 24 hours, and nocturia 4-5 times/night.

A consultation with an infectious disease specialist resulted in the placement of a PICC line to facilitate the home administration of cephalosporin for treatment of presumed prostatitis. Specialist prescribed OxyContin^® (oxycodone HCI, 140 mg/day) for management of severe pain. Other drugs included Flomax^® (tamsulosin HCI), Imitrex^® (sumatriptan succinate), and ibuprofen.

Physical Examination Prior to Implantation

Patient presented in significant physical distress, afebrile, vital signs stable, PICC line in left arm. Normal GU exam: prostate small, non-tender, not boggy or fluctuant. Urinalysis and culture: negative. PSA 0.5 ng/mL.

Clinician stopped IV antibiotics and prescribed pentosan polysulfate (100 mg TID) and hydroxyzine (50 mg QHS) for the treatment of possible interstitial cystitis.

Follow-Up

In April 2001, acystoscopy with hydrodistension showed:

• 900 cc. capacity
• Minimal inflammatory changes in the bladder
• No improvement

In June 2001, the patient was experiencing worsening urgency, frequency, and pain resulting in treatment with Prozac^® (fluoxetine hydrochloride) for depression.

In August 2001, the patient was continuing pain required treatment with OxyContin (140 mg/day).

Symptoms included:

• Urinary frequency 25-35 times in 24 hours
• Nocturia 2-3 times per night

Patient Response to the Sacral Nerve Stimulation Test Procedure*

Test procedure performed August 29, 2001, resulted in:

• Marked improvement in symptoms during week 1
• Urinary frequency declined from 25 voids per day to 7 voids per day

Patient Response to the Sacral Nerve Stimulation Implant Procedure*

Implantation performed September 12, 2001 resulted in:

• Continued improvement: voiding frequency normalized, volumes increased
• Antidepressant medication was stopped
• No adverse events since implantation
• Patient remains active (skiing, playing basketball, etc)
• Device has needed reprogramming only 2 times in 4 years

*Results may vary. Not all patients will experience the same results.

This case study recounts the experience of one patient receiving InterStim^® Therapy. Experiences are specific to this particular person. Results vary, and not every response is the same.

In addition to the risks related to any medical procedure, complications from this intervention can include: pain, infection, sensation of electrical shock, device problems, undesirable change in voiding function, and lead migration, among others.

Patient Profile

45-year-old woman with urge incontinence and urgency frequency. History of midurethral sling for worsening stress urinary incontinence (SUI). Noticed worsening urgency and increased urinary leakage after the sling.

Flow was slower, but good stream and a sense that she empties completely. Denies any stress urinary leakage but her incontinence is “worse than before the sling." Voids frequently, yet leaks before she can make it to the bathroom. At least 5 incontinence episodes per day, as well as up to 2 to 3 times per night.

Wears 4 Poise^® pads per day. Other medical conditions include depression and irritable bowel syndrome.

Intervention Prior to Referral

Received Detrol^® LA (tolterodine tartrate) 4 mg/day at 2 weeks postoperatively because it had improved her overactive bladder (OAB) symptoms before the sling.

Continued with 6 episodes of urge incontinence per day, plus 2 episodes of nocturia, and wearing 4 to 5 pads per day. Enrolled in focused pelvic floor rehabilitation program with nurse practitioner and switched to ENABLEX^® (darifenacin) 7.5 mg per day without any improvement. After 4 weeks, ENABLEX was increased to 15 mg per day.

Had 4 episodes of urge incontinence per day, in addition to 2 episodes of nocturia. Stopped ENABLEX because she was still having urinary leakage, and complained of dry mouth and constipation.

Results of Testing Upon Referral

3-day Bladder Diary

• 5 episodes of urinary leakage per day, all urge related
• 2 episodes of nocturia
• Average voided volume=120 cc.
• Functional bladder capacity=350 cc.
• 24-hour urine output=1800 cc.
• Average number of voids per day=10
• 24-hour pad weight=3 pads weighing 370 gms

Pelvic Examination

• No evidence of prolapse
• Sling not palpable, urethra not retropexed
• Pelvic floor muscle strength 6/9

Urinalysis

• Negative for infection or red blood cells

Clinical Evidence for Appropriateness of Sacral Nerve Stimulation

The patient's refractory urinary urgency frequency and urge incontinence had not improved significantly with standard intervention of pelvic floor rehabilitation and 2 different anticholinergic medications.

The patient was evaluated and urethral obstruction was ruled out as cause for OAB symptoms. The InterStim test stimulation procedure was discussed with patient and information was given about the intervention.

Patient Response to the Sacral Nerve Stimulation Test Procedure*

On the first night after implantation, the patient was able to sleep through the entire night. She immediately noticed a decrease in urgency and urge-incontinent episodes.

The diary was reviewed after 5 days, and the patient noticed:

• 1-2 mild episodes of leakage over the 5-day period
• Average voided volume per day=200 cc.
• 7 voids per day with no nocturia

Patient Response to the Sacral Nerve Stimulation Implant Procedure*

The device was placed on day 7 after first stage lead placement. At 6 weeks postoperatively, the patient continued to be 95% improved. She is no longer wearing a pad for “protection." Although she experiences occasional urgency with a full bladder, she no longer has incontinent episodes on a daily basis.

*Results may vary. Not all patients will experience the same results.

This case study recounts the experience of one patient receiving InterStim^® Therapy. Experiences are specific to this particular person. Results vary, and not every response is the same.

In addition to the risks related to any medical procedure, complications from this intervention can include: pain, infection, sensation of electrical shock, device problems, undesirable change in voiding function, and lead migration, among others.

Patient Profile

43-year-old female high school teacher with 3 young children. Six-year history of urinary urgency, urinary frequency, and nocturia. History of chronic pelvic pain and endometriosis. Symptoms interfered with her daily activities and affected her quality of life.

At the time of referral, the patient was voiding 20 times per day and 4-5 times during the night. The patient subjectively rated symptoms as a 3-4 on a scale of 0-4.

Intervention Prior to Referral

Treated with 10 mg/day Ditropan XL® (oxybutynin chloride) and 4 mg/day Detrol® LA (tolterodine tartrate) with no relief of symptoms. The patient tried chiropractic care, acupuncture, and Chinese herbs to manage symptoms but these methods were unsuccessful.

Prior treatment also included Lupron Depot® (leuprolide acetate for depot suspension), which did not provide relief of symptoms.

The patient underwent a total abdominal hysterectomy with bilateral salpingo-oophorectomy (TAH/BSO) for endometriosis. However, symptoms of urgency, frequency, and low back pain continued.

Physical Examination Prior to Implantation

Following referral, the patient underwent a complete history and physical examination, including a detailed pelvic exam, which did not reveal any significant pelvic organ prolapse. Tenderness over the pelvic floor muscle was noted, especially over the right obturator internus.

Initial urinalysis did not reveal any hematuria or abnormal cytology. Cystoscopy revealed normal vascular pattern with no evidence of petechiae, but mild trabeculation at maximum capacity.

Urodynamic evaluation confirmed low bladder capacity of 350 ccs; no detrusor overactivity was noted.

The patient underwent intensive pelvic floor physical therapy in conjunction with pudendal blocks for a 6-month period. This significantly improved pelvic pain but caused only modest improvement in urgency/frequency symptoms. The patient continued to void approximately once per hour during the day and 3 times during the night.

The patient was then given a third anticholinergic (VESIcare® [solifenacin succinate] 5 and 10 mg/day) and Elavil® (amitriptyline) 25 mg/day, neither of which had an impact on her symptoms.

Follow-up

After failure of multiple modalities of therapy (behavioral and pharmacological), the patient and physician discussed other options, including sacral nerve stimulation (InterStim Therapy). The patient received written information regarding InterStim Therapy, as well as a DVD about the procedure. All questions were answered and the patient elected to proceed with test stimulation.

Patient Response to the Sacral Nerve Stimulation Test Procedure*

The patient underwent placement of the InterStim lead wire in the right S3 foramen. Over the trial stimulation period, the patient noted a dramatic reduction in her urgency and frequency symptoms.

Subjectively, the patient rated her urgency as 0-1 on a scale of 0-4. Frequency decreased to every 2 to 3 hours and patient was sleeping through the night, getting up only occasionally.

Patient Response to the Sacral Nerve Stimulation Implant Procedure*

The patient was very happy with test stimulation results and elected to proceed with placement of the InterStim II IPG. Intraoperatively, the patient had a positive bellows and great toe motor response with stimulation at 1.2 mA.

The patient feels the sensation of vaginal tapping.

At 3 month follow-up, the patient reported time periods of up to 4 hours between voids. She reported no adverse events associated with InterStim. 

*Results may vary. Not all patients will experience the same results.

This case study recounts the experience of one patient receiving InterStim Therapy. Experiences are specific to this particular person. Results vary, and not every response is the same.

In addition to the risks related to any medical procedure, complications from this intervention can include: pain, infection, sensation of electrical shock, device problems, undesirable change in voiding function, and lead migration, among others.

Patient Profile

47-year-old female with urgency-frequency, urge incontinence, and stress incontinence, with symptoms present for 17 years. The patient reported a significant impact on her quality of life. At the time of referral, the patient was voiding 16 times per day and 4 times at night. The patient complained of urinary leakage when coughing and during physical activities such as walking, exercising and standing from a sitting position. She also complained of bothersome urgency and urge incontinence.

The patient wore 5 adult diapers per day, changed clothing multiple times, and ceased sexual activity. Prior medical history was notable for hypertension and occasional migraine headaches.

The patient underwent cystocele repair and suburethral sling surgery and was cured of stress incontinence. Urge incontinence persisted. Six months post-surgery, the patient was voiding 14 times per day and twice at night. She had 3 urge incontinence episodes per day and was wearing 3 pads a day.

Intervention Prior to Referral

The patient had been seeing her primary care physician for symptoms. She failed previous trials of fluid and caffeine restriction, pelvic floor exercises, and multiple antimuscarinic medications.

The patient was treated with Detrol® LA (tolterodine tartrate), VESIcare® (solifenacin succinate) and Enablex® (darifenacin), with no relief of symptoms.

Physical Examination Prior to Implantation

Physical examination showed significant urethral hypermobility and heavy leakage with straining; the patient did not complain of any pelvic pain.

Following referral, the patient underwent video urodynamic evaluation, which revealed detrusor overactivity with concomitant leakage, a bladder capacity of 400 cc, and an abdominal leak point pressure of 80 cm H2O. Electromyography was normal, and fluoroscopy demonstrated rotational descent of the bladder neck (and leakage) with straining.

Following prolapse surgery, urge incontinence persisted. Repeat pelvic examination revealed no evidence of pelvic prolapse or other abnormalities. There was no leakage with straining.

The patient did not respond to reintroduction of behavioral modification, pelvic floor exercises, and antimuscarinic medications. Repeat urodynamics demonstrated persistent detrusor overactivity, but no stress incontinence.

Follow-up

After failure of multiple modalities of therapy (behavioral and pharmacological), the physician counseled the patient on other options, including InterStim Therapy.

The patient was referred to the website (www.medtronic.com) and provided with written information regarding InterStim Therapy.

All questions were answered and the patient elected to proceed with test stimulation.

Patient Response to the Sacral Nerve Stimulation Test Procedure*

The patient underwent S3 foramenal placement of InterStim lead wire. Over the trial period, the patient experienced a notable decrease in symptoms.

Voiding frequency decreased to 7 to 8 times per day and once at night, and only 1 urge incontinence episode during the 4-day trial.

Patient Response to the Sacral Nerve Stimulation Implant Procedure*

The patient elected to proceed with placement of the InterStim II System. Intraoperatively, the patient had a positive bellows and great toe motor response with stimulation at 3 volts.

At 12-month follow-up, the patient reported voiding 9 times per day and once at night and had no reported urge incontinence. The patient reported no adverse events associated with InterStim.

*Results may vary. Not all patients will experience the same results.

This case study recounts the experience of one patient receiving InterStim Therapy. Experiences are specific to this particular person. Results vary, and not every response is the same.

In addition to the risks related to any medical procedure, complications from this intervention can include: pain, infection, sensation of electrical shock, device problems, undesirable change in voiding function, and lead migration, among others.