June 2010 · Vol.22, No.6Medtronic InterStim® therapy for urinary control case study: Urinary urgency-frequency
Stanley Zaslau, MD, MBA, FACSAssociate Professor and Associate Program Director, Division of Urology, West Virginia University, Morgantown, West Virginia
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DISCLOSURE
Dr Zaslau reports that he is a consultant for Medtronic Inc.
The content of this supplement was developed by the sponsor, Medtronic Inc., as a service to the readers of OBG Management. This case study recounts the experience of one patient receiving InterStim Therapy. Results vary, and not every response is the same.
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 Patient profile
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33-year-old female with 4-year history of urinary urgency-frequency
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Voiding episodes: 25/day, 5/night
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Experiences decreased force of urinary stream; strains to void
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Consulted with several specialists, including 2 urologists and 1 urogynecologist
Treatment and results prior to InterStim Therapy referral
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Six months of oxybutynin and pentosan polysulfate sodium resulted in slight reduction in voiding episodes to 20/day, 4/night
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Six weeks of treatment with intravesical dimethyl sulfoxide resulted in temporary reduction of voiding episodes to 18/day
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Four months of solifenacin succinate and amitriptyline resulted in no change in symptoms
Physical exam prior to InterStim Therapy test procedure
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Pelvic: No evidence of prolapse; significant tenderness along anterior vaginal wall
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Urinalysis and cytology: Trace microhematuria; no malignant cells
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Cystoscopy: Numerous glomerulations at bladder base; 175 cc bladder capacity, pain upon filling
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Renal/bladder ultrasound: No evidence of renal masses or hydronephrosis
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Urodynamics: Sensory urgency; impaired relaxation of external urinary sphincter; 11 cc/sec maximum flow rate with straining; 40 cm H20 maximum detrusor pressure during voiding
InterStim Therapy referralFrustrated with chronic urgency-frequency, and poor response to conventional treatment, the patient opted for a trial period with InterStim Therapy. Upon learning that the trial was a simple in-office procedure, she decided to test not only its efficacy but also the sensation and her tolerance. This would help her and her physician make an informed decision about proceeding to implantation. Trial period
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After 2 days, voiding episodes reduced: 12/day, 1/night
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Urinary stream subjectively improved
InterStim Therapy system
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Implanted 2 weeks after trial
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Voiding episodes after implantation: 10/day, 0-1/night
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No adverse events reported
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Patient’s subjective evaluation very much improved
Follow-up at 2 years
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Patient reports symptoms to be 75% better than what they were prior to InterStim Therapy
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Further reduction in voids at 2-year follow-up: 6/day, 0-1/night
ConclusionPatient experienced significant relief from her symptoms of urinary urgency-frequency with InterStim Therapy and continues to do well at 2-year follow-up. About InterStim TherapyMedtronic InterStim Therapy for urinary control has been shown to successfully treat symptoms of overactive bladder and urinary retention in patients for whom more conservative treatments were unsuccessful.1,2 InterStim Therapy addresses the nerve component of bladder control problems by sending mild electrical pulses to the sacral nerves which influences the bladder and surrounding muscles that manage urinary function. A simple test procedure, initiated in your office, gives you and your patients an opportunity to find out in as few as 3 days if InterStim Therapy will work for them. More than 75,000 patients worldwide have received InterStim Therapy. Safety information
Medtronic InterStim Therapy for urinary control has been shown to successfully treat symptoms of overactive bladder and urinary retention in patients for whom more conservative treatments were unsuccessful
1,2. InterStim therapy focuses on the nerves that control the pelvic floor and lower urinary tract. It offers control of symptoms through direct modulation of the nerve activity, making it different from oral medications3,4. A simple test procedure, initiated in your office, gives you and your patients an opportunity to find out in as few as 3 days if InterStim Therapy will work for them. More than 75,000 patients worldwide have received InterStim Therapy. 1. Medtronic-sponsored research. InterStim Therapy Clinical Summary Insert, 2006.
2. Van Kerrebroeck PE, van Voskuilen AC, Heesakkers JP, et al. Results of sacral neuromodulation therapy for urinary voiding dysfunction: outcomes of a prospective, worldwide clinical study. J Urol. 2007;178(5):2029–2034.
3. Griebling TL. Neuromodulation: mechanisms of action. In: Kreder K, Dmochowski R, eds. The Overactive Bladder: Evaluation and Management. London, England: Informa UK Ltd; 2007:293-302.
4. Leng WW, Chancellor MB, How sacral nerve stimulation neuromodulation works. Urol Clin North Am. 2005;32:11–18
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IMPORTANT SAFETY INFORMATION
InterStim Therapy for urinary control is indicated for the treatment of urinary retention and the symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in patients who have failed or could not tolerate more conservative treatments.
Contraindications: Diathermy. Patients who have not demonstrated an appropriate response to test stimulation or are unable to operate the neurostimulator.
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Warning: This therapy is not intended for patients with mechanical obstruction such as benign prostatic hypertrophy, cancer, or urethral stricture.
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Precautions/adverse events: Safety and effectiveness have not been established for bilateral stimulation; pregnancy, unborn fetus, and delivery; pediatric use under the age of 16; or for patients with neurological disease origins such as multiple sclerosis. The system may be affected by or adversely affect cardiac devices, electrocautery, defibrillators, ultrasonic equipment, radiation therapy, MRI, theft detectors/screening devices. Adverse events include pain at the implant sites, new pain, lead migration, infection, technical or device problems, adverse change in bowel or voiding function, and undesirable stimulation or sensations, including jolting or shock sensations. For full prescribing information, please call Medtronic at 1-800-328-0810 and/or consult Medtronic’s Web site at www.medtronic.com. Product technical manual must be reviewed prior to use for detailed disclosure. USA Rx Only. Rev 0409.
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