257
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`Abstract Reproduction Form B-l
`Abstract Reproduction Form B-1
`
`Author(s):
`
`Marshall L. Stoller
`
`University of California, San Francisco
`~nsti~nion University of California, San Francisco
`Institution
`San Francisco, California
`W
`City
`San Francisco, California
`United States
`United States
`coumy
`Country
`
`(type m AFFERENT NERVE STlMULATlON FOR PELVIC FLOOR DYSFUNCTION
`Title (type In AFFERENT NERVE STIMULATION FOR PELVIC FLOOR DYSFUNCTION
`f ~ e
`cAprrAL
`CAPITAL
`LETTERS)
`
`Aims of Studv: Pelvic floor dysfunction may manifest itself as urinary urgeJfrequency, urge
`Alms of Study: Pelvic floor dysfunction may manifest itself as urinary urge/frequency, urge
`incontinence, and/or pelvic pain. Few effective treatment modalities have been available for
`incontinence, and/or pelvic pain. Few effective treatment modalities have been available for
`these disabled patients, though multiple therapies have been used including medications,
`these disabled patients, though multiple therapies have been used including medications,
`biofeedback, pelvic fkor exercises, and efferent nerve stimulation. The purpose of this study
`biofeedback, pelvic floor exercises, and efferent nerve stimulation. The purpose of this study
`was to document long-term follow-up data regarding minimally invasive afferent nerve
`was to document long-term folbw-up data regarding minimally invasive afferent nerve
`stimulation for pelvic floor dysfunction.
`stimulation for pelvic fkor dysfunction.
`Ninety patients were successfully screened with cystoscopy, voiding
`Ninety patients were successfully screened with cystoscopy, voiding
`Methods;
`Methods;
`cystourethrography, basefine urodynamics, urine cultures, and voiding/pain diaries, and entered
`cystourethrography, baseline urodynamIcs, urine cultures, and voiding/pain diaries, and entered
`into the study. A 34-gauge stainless steel needle was inserted approximately 5 cm cephalad
`stainless steel needle was inserted approximately 5 cm cephalad
`into the study. A *gauge
`from the medial rnalleolus and just posterior to the margin of the tibia. It was advanced to the
`from the medial malleolus and just posterior to the margin of the tibia. It was advanced to the
`medial edge of the fibula. Electrical stimulation was applied to the needle with a low voltage,
`medial edge of the fibula. Electrical stimulation was applied to the needle with a low voltage,
`adjustable current, external pulse generator, and to the medial surface of the calcaneous.
`adjustable current, external pulse generator, and to the medial surface of the calcareous.
`Patients were treated with one electrical stimulation per week for 20-30 minutes per session for
`Patients were treated with one electrical stimulation per week for 20-30 minutes per session for
`10 consecutive weeks. Post-treatment voidinglpain diaries were compared to baseline values.
`10 consecutive weeks. Post-treatment voiding/pain diaries were compared to baseline values.
`Results: Patients have been treated with a mean fdbw-up of 5.1 years. They had (on average)
`results: Patients have been treated with a mean follow-up of 5.1 years. They had (on average)
`exgerienced symptoms for 5.5 years, sought help from 5.7 physicians, and attempted 4 previous
`experienced symptoms for 5.5 years, sought help from 5.7 physicians, and attempted 4 previous
`treatments prior to entering the protocol. A substantial number of patients had attempted
`treatments prior to entering the protocol. A substantial number of patients had attempted
`suicide due to the hopeless nature of their situation prior to therapy. There were no adverse
`suicide due to the hopeless nature of their situation prior to therapy. There were no adverse
`effects of therapy including infection, hemorrhage or exacerbation of symptoms. A successful
`effects of therapy including Infection, hernorthage or exacerbation of symptoms. A successful
`outcome, defined as at least a 50% imprwement of symptoms, as documented by voidinglpain
`outcome, defined as at least a 50% improvement of symptoms, as documented by voiding/pain
`diaries was seen in 81 % of patients. Follow up therapy was individualized for patients with
`diaries was seen in 81% of patients. Follow up therapy was individualized for patients with
`successful results, slowly increasing the interval between treatments, and instructing select
`successful results, slowly increasing the interval between treatments, and instructing select
`patients for home administered therapy.
`patients for home administered therapy.
`Conclusions: Afferent nerve stimulation is a viable treatment therapy for patients with pelvic
`Conclusions: Afferent nerve stimulation is a viable treatment therapy for patients with pelvic
`floor dysfunction. Based on these promising long-term percutaneous results, a minimally
`floor dysfunction. Based on these promising bng-term percutaneous results, a minimaiiy
`invasive peripheral implant device is being developed.
`invasive peripheral implant device is being developed.
`
`256
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`Petitioner - Avation Medical, Inc.
`Ex. 1015, p. 256
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