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Diane Newman RN has written a fabulous summary of a speech given by Ken Peters in February 2011 at the PACS conference in Dubai. She shares the data offered on sacral nerve stimulation and pudendal nerve stimulation. But, what makes this particularly exciting is the review of the newest studies which show that tibial nerve stimulation (performed at the ankle and with minimal side effects or trauma) is extremely successful with one study showing a 71% effectiveness rating. I was an early PTNS patient when it was first developed at UCSF by Dr. Marshall Stoller... and I'm delighted to see the best neuromodulation specialist in the world (Dr. Peters) offer enthusiasm for this much less invasive yet apparently similarly successful nerve stimulation approach. - Jill
PACS 2011 - Advanced neuromodulation: Sacral, pudendal and tibial - Session Highlights by Diane Newman. March 18, 2011
DUBAI, UAE (UroToday.com) - In the opinion of Dr. Ken Peters, neuromodulation is changing the future of urology as treatment of voiding dysfunction, and he believes that other disorders, such as pelvic pain, sexual dysfunction and bowel disorders, will no longer rely only on medications or destructive/reconstructive surgeries that suffer from significant complications. Rather, by modulating the nerves via several current and promising future modalities, clinicians will treat these disorders in a minimally invasive fashion and neuromodulation will become the first-line therapy before any major reconstructive surgery is undertaken.
Figure 1. - Figures can be seen in the original article on the urotoday.com website.
He began his lecture noting that the pontine micturition center (PMC) is the major relay center between the brain and the bladder. The function of the PMC is to coordinate the activities of the urinary sphincters and the bladder so that they work in synergy. It also coordinates the urethral sphincter relaxation and detrusor contraction to facilitate urination.
Sacral nerve stimulation (SNS) (InterStim by Medtronic) is approved for urinary urgency, frequency, urge incontinence and non-obstructive urinary retention in patients who have not been helped or could not tolerate more conventional treatments, including pharmacotherapy. SNS utilizes mild electrical pulses to the nerves associated with voiding function. Dr. Peters reported that over 75,000 implants have been performed worldwide.
Interstim initially began as a staged approach where placement of a sacral electrode was initially a complex surgery requiring large incisions and hospitalization. The staged approach was when a foramen needle was passed at a 60-degree angle through superior, medial aspect of foramen, and current was applied to assess sensory and motor response. The ideal response is a comfortable pulsating sensation in the rectal, genital area, sacral flattening, and small amount of greater toe movement. The quadripolar tined lead is advanced so that the proximal electrode is at the lower bone plate. Each electrode is tested for motor and sensory response and adjusted as necessary to achieve optimal response. The lead introducer is carefully removed, deploying the tines. Following placement, patients are sent home with a screener box for 14 to 21 days and instructed to adjust voltage to comfortable stimulation. Adjustments can be made over the phone or in the office regarding the electrode stimulated rate and pulse-width. Patients are instructed to keep voiding diaries. They are then advanced to an implantable pulse generator (IPG or implantable nerve stimulator - INS) if at least a 50% improvement in symptoms is seen on the diaries.
Stage II Interstim involves marking a site on the buttock for incision for the IPG. The medial portion of this incision is where the connector of the temporary extension lead is buried. The incision is carefully opened and the proximal permanent lead is externalized with its connection to the percutaneous lead. The surgeon removes the percutaneous lead by loosening a set screw. A subcutaneous pocket is created, large enough to accommodate the IPG.
Figure 2.
Peters KM. (2004) Neuromodulation, staged intervention, and new instruments. Atlas Urol Clin. 12:275-291.
Siegel, et al. (2000) reported on long -term results of a multicenter study on the InterStim that demonstrate, that after 3 years, 59% of 41 urge UI patients showed greater than 50% reduction in leaking episodes per day with 46% of patients being completely dry. After 2 years, 56% of the urgency-frequency patients showed greater than 50% reduction in voids per day. After 1.5 years, 70% of 42 retention patients showed greater than 50% reduction in catheter volume per catheterization.
Siegel SW, Catanzaro F, Dijkema HE, Elhilali MM, Fowler CJ, Gajewski JB, Hassouna MM, Janknegt RA, Jonas U, van Kerrebroeck PE, Lycklama a Nijeholt AA, Oleson KA, Schmidt RA. (2000) Long-term results of a multicenter study on sacral nerve stimulation for treatment of urinary urge incontinence, urgency-frequency, and retention. Urology. 56(6 Suppl 1):87-91.
More recently, an office test called the “Peripheral Nerve Evaluation” or PNE has become popular as it is a minimally-invasive procedure.
Dr. Peters went on to describe pudendal nerve stimulation (PNS). Stimulation of the 3rd sacral nerve has been shown to be effective in treating voiding dysfunction. The pudendal nerve is a distal branch of S2, S3, and S4 so the potential benefit of PNS is increased afferent stimulation through the sacral nerve roots. He provided a review of early studies that was done in cats (Walters, 1993) and dogs (Yamanishi, 1999). He then provided a review of early clinical research in PNS by Ohlsson (1989). He then reported on his experience (Peters, 2005) with PNS which was the first blinded study of sacral versus pudendal stimulation for voiding dysfunction. Dr. Peters reviewed how he performed the procedure. Subjects received 15 minutes of pudendal stimulation and underwent pre- and post- stimulation CMGs. Results indicated successful implantation of a pudendal lead was achieved in all subjects. 24/30 (80%) responded and had a permanent generator placed with 19/24 (79.2%) pudendal implant and 5/24 (20.8%) sacral implant. Six subjects had it removed due to poor response to either lead. He found that the order in which the leads were stimulated had no impact on the final lead implanted, confirming appropriateness of the crossover design. The majority of subjects chose PNS to be superior to SNS. More patients and longer term data are needed to confirm these promising results
Ohlsson BL, Fall M, Frankenberg-Sommar S. (1989) Effects of external and direct pudendal nerve maximal electrical stimulation in the treatment of the uninhibited overactive bladder. Br J Urol. 64(4):374-80
Peters KM, Feber KM, Bennett RC. (2005) Sacral versus pudendal nerve stimulation for voiding dysfunction: a prospective, single-blinded, randomized, crossover trial. Neurourol Urodyn. 24(7):643-7.
Peters KM. (2010) Alternative approaches to sacral nerve stimulation. Int Urogynecol J Pelvic Floor Dysfunct. 21(12):1559-63.
Walter JS, Wheeler JS, Robinson CJ, Wurster RD. (1993) Inhibiting the hyperreflexic bladder with electrical stimulation in a spinal animal model. Neurourol Urodyn. 12(3):241-52;
Yamanishi T, Yasuda K, Sakakibara R, Suda S, Ishikawa N, Hattori T, Hosaka H. (1999) Induction of urethral closure and inhibition of bladder contraction by continuous magnetic stimulation. Neurourol Urodyn. 18(5):505-10.
Dr. Peters (2010) published the results of a retrospective chart review from November 2003 to June 2008 of patients (n=67, 80.6% female, 19.4% male, mean age: 54.5 years) with pudendal nerve lead placement. Primary diagnoses were interstitial cystitis/PBS (n=26), urgency/frequency or urge UI (n=29), urinary retention (n=9), pelvic pain (n=2), and tethered sacral cord (n=1). Three patients had peripheral neuropathy. With a mean follow-up of 32.3 months, over 90% of patients who failed SNS responded to PNS. Complications included superficial wound infections, pain (back pain, leg pain, sciatic pain and shocks), reoperations for lead replacement, migration, etc.
Dr. Peters feels that ONS is an alternative to sacral stimulation, it stimulates S2, S3, and S4, is more desired than sacral and salvages >90% of sacral failures. However, there is no multicenter pivotal trial and it does not have widespread adoption.
Peters KM, Killinger KA, Boguslawski BM, Boura JA. (2010) Chronic pudendal neuromodulation: expanding available treatment options for refractory urologic symptoms. Neurourol Urodyn. 29(7):1267-71
Figure 3.
The best portion of Dr. Peters lecture was on percutaneous tibial nerve stimulation (PTNS). The tibial nerve sends afferents through the sacral nerve plexus and has been studied since the 1980s for the treatment of OAB but only recently have there been controlled trials (Peters, 2010). The procedure involves locating the posterior tibial nerve above the medial malleolus and inserting a 34-gauge, percutaneous solid needle several inches (see Figure). A ground surface electrode is placed over the ipsilateral calcaneus. The needle is connected to a low-voltage stimulator. Stimulation of the nerve results in a sensory response causing a tickling sensation in the sole of the big toe and a motor response causing plantar flexion of the big toe and fanning of the remaining toes. If the big toe bends downward with stimulation, the needle’s placement is ideal.
Peters (2009) enrolled subjects (n=100) with OAB who were randomized to either treatment with tolterodine-ER or PTNS. A 12 week trial demonstrated comparable effectiveness from a Global Response Assessment of weekly PTNS (79.5% improved or cured) to extended-release tolterodine (54.8% improved or cured). Greater than 95% of subjects maintained their objective and subjective response of decreased urinary frequency at 6 and 12 months.
Peters KM, Macdiarmid SA, Wooldridge LS, Leong FC, Shobeiri SA, Rovner ES, Siegel SW, Tate SB, Jarnagin BK, Rosenblatt PL, Feagins BA (2009)
Randomized trial of percutaneous tibial nerve stimulation versus extended-release tolterodine: results from the overactive bladder innovative therapy trial. J Urol. 182(3):1055-61.
Figure 4.
The most recent PTNS study (SUmiT= The Study of Urgent® PC vs. Sham Effectiveness in Treatment of Overactive Bladder Symptoms) was an intent-to-treat multi-center study to assess the efficacy of PTNS therapy compared to validated inactive sham therapy in women and men (n=220) with OAB symptoms. Subjects received 12 weekly 30-minute therapy sessions. The sham consisted of 2 inactive surface electrodes placed on the subject’s foot to mimic the sham therapy – one under subjects' little toes and one of top of the foot. The primary endpoint was a determined by moderate or marked improvement on a seven-level Global Response Assessment (GRA) and is shown in Figure 4.
The researchers concluded that this multi-center, double-blind, sham-controlled trial provides Level I clinical evidence that the therapeutic effect of PTNS is not due to a placebo effect but rather to stimulation of the tibial nerve with significant improvement in OAB symptoms. PTNS is effective, lacks major side effects and may be considered a primary treatment for OAB symptoms.
Peters KM, Carrico DJ, Perez-Marrero RA, Khan AU, Wooldridge LS, Davis GL, Macdiarmid SA. (2010) Randomized trial of percutaneous tibial nerve stimulation versus Sham efficacy in the treatment of overactive bladder syndrome: results from the SUmiT trial. J Urol. 183(4):1438-43.
Finazzi-Agrò (2010) published a prospective, double-blind, placebo controlled study, based on an original placebo technique, performed to evaluate the efficacy of percutaneous tibial nerve stimulation in female patients (n=35) with detrusor overactivity incontinence. Although a smaller number of subjects, conclusions were similar to the peters (2010) study. PTNS was effective with 71% of patients considered responders, while none of those treated with placebo were considered responders. They concluded that the relevance of a placebo effect seems to be negligible in this patient population.
Finazzi-Agrò E, Petta F, Sciobica F, Pasqualetti P, Musco S, Bove P. (2010) Percutaneous tibial nerve stimulation effects on detrusor overactivity incontinence are not due to a placebo effect: a randomized, double-blind, placebo controlled trial. J Urol. 184(5):2001-6.
Presented by Kenneth M. Peters, MD at the 7th Pan Arab Continence Society (PACS) Annual Meeting - February 3 - 5, 2011 - Dubai, United Arab Emirates
Reported for UroToday by Diane K. Newman, RNC, MSN, CRNP, FAAN and Continence Nurse Practitioner Specialist - University of Pennsylvania Medical Center.
REPRINTED WITH PERMISSION OF UROTODAY! Read the full article at: http://www.urotoday.com/index.php?op...2567&Itemid=26
PACS 2011 - Advanced neuromodulation: Sacral, pudendal and tibial - Session Highlights by Diane Newman. March 18, 2011
DUBAI, UAE (UroToday.com) - In the opinion of Dr. Ken Peters, neuromodulation is changing the future of urology as treatment of voiding dysfunction, and he believes that other disorders, such as pelvic pain, sexual dysfunction and bowel disorders, will no longer rely only on medications or destructive/reconstructive surgeries that suffer from significant complications. Rather, by modulating the nerves via several current and promising future modalities, clinicians will treat these disorders in a minimally invasive fashion and neuromodulation will become the first-line therapy before any major reconstructive surgery is undertaken.
Figure 1. - Figures can be seen in the original article on the urotoday.com website.
He began his lecture noting that the pontine micturition center (PMC) is the major relay center between the brain and the bladder. The function of the PMC is to coordinate the activities of the urinary sphincters and the bladder so that they work in synergy. It also coordinates the urethral sphincter relaxation and detrusor contraction to facilitate urination.
Sacral nerve stimulation (SNS) (InterStim by Medtronic) is approved for urinary urgency, frequency, urge incontinence and non-obstructive urinary retention in patients who have not been helped or could not tolerate more conventional treatments, including pharmacotherapy. SNS utilizes mild electrical pulses to the nerves associated with voiding function. Dr. Peters reported that over 75,000 implants have been performed worldwide.
Interstim initially began as a staged approach where placement of a sacral electrode was initially a complex surgery requiring large incisions and hospitalization. The staged approach was when a foramen needle was passed at a 60-degree angle through superior, medial aspect of foramen, and current was applied to assess sensory and motor response. The ideal response is a comfortable pulsating sensation in the rectal, genital area, sacral flattening, and small amount of greater toe movement. The quadripolar tined lead is advanced so that the proximal electrode is at the lower bone plate. Each electrode is tested for motor and sensory response and adjusted as necessary to achieve optimal response. The lead introducer is carefully removed, deploying the tines. Following placement, patients are sent home with a screener box for 14 to 21 days and instructed to adjust voltage to comfortable stimulation. Adjustments can be made over the phone or in the office regarding the electrode stimulated rate and pulse-width. Patients are instructed to keep voiding diaries. They are then advanced to an implantable pulse generator (IPG or implantable nerve stimulator - INS) if at least a 50% improvement in symptoms is seen on the diaries.
Stage II Interstim involves marking a site on the buttock for incision for the IPG. The medial portion of this incision is where the connector of the temporary extension lead is buried. The incision is carefully opened and the proximal permanent lead is externalized with its connection to the percutaneous lead. The surgeon removes the percutaneous lead by loosening a set screw. A subcutaneous pocket is created, large enough to accommodate the IPG.
Figure 2.
Peters KM. (2004) Neuromodulation, staged intervention, and new instruments. Atlas Urol Clin. 12:275-291.
Siegel, et al. (2000) reported on long -term results of a multicenter study on the InterStim that demonstrate, that after 3 years, 59% of 41 urge UI patients showed greater than 50% reduction in leaking episodes per day with 46% of patients being completely dry. After 2 years, 56% of the urgency-frequency patients showed greater than 50% reduction in voids per day. After 1.5 years, 70% of 42 retention patients showed greater than 50% reduction in catheter volume per catheterization.
Siegel SW, Catanzaro F, Dijkema HE, Elhilali MM, Fowler CJ, Gajewski JB, Hassouna MM, Janknegt RA, Jonas U, van Kerrebroeck PE, Lycklama a Nijeholt AA, Oleson KA, Schmidt RA. (2000) Long-term results of a multicenter study on sacral nerve stimulation for treatment of urinary urge incontinence, urgency-frequency, and retention. Urology. 56(6 Suppl 1):87-91.
More recently, an office test called the “Peripheral Nerve Evaluation” or PNE has become popular as it is a minimally-invasive procedure.
Dr. Peters went on to describe pudendal nerve stimulation (PNS). Stimulation of the 3rd sacral nerve has been shown to be effective in treating voiding dysfunction. The pudendal nerve is a distal branch of S2, S3, and S4 so the potential benefit of PNS is increased afferent stimulation through the sacral nerve roots. He provided a review of early studies that was done in cats (Walters, 1993) and dogs (Yamanishi, 1999). He then provided a review of early clinical research in PNS by Ohlsson (1989). He then reported on his experience (Peters, 2005) with PNS which was the first blinded study of sacral versus pudendal stimulation for voiding dysfunction. Dr. Peters reviewed how he performed the procedure. Subjects received 15 minutes of pudendal stimulation and underwent pre- and post- stimulation CMGs. Results indicated successful implantation of a pudendal lead was achieved in all subjects. 24/30 (80%) responded and had a permanent generator placed with 19/24 (79.2%) pudendal implant and 5/24 (20.8%) sacral implant. Six subjects had it removed due to poor response to either lead. He found that the order in which the leads were stimulated had no impact on the final lead implanted, confirming appropriateness of the crossover design. The majority of subjects chose PNS to be superior to SNS. More patients and longer term data are needed to confirm these promising results
Ohlsson BL, Fall M, Frankenberg-Sommar S. (1989) Effects of external and direct pudendal nerve maximal electrical stimulation in the treatment of the uninhibited overactive bladder. Br J Urol. 64(4):374-80
Peters KM, Feber KM, Bennett RC. (2005) Sacral versus pudendal nerve stimulation for voiding dysfunction: a prospective, single-blinded, randomized, crossover trial. Neurourol Urodyn. 24(7):643-7.
Peters KM. (2010) Alternative approaches to sacral nerve stimulation. Int Urogynecol J Pelvic Floor Dysfunct. 21(12):1559-63.
Walter JS, Wheeler JS, Robinson CJ, Wurster RD. (1993) Inhibiting the hyperreflexic bladder with electrical stimulation in a spinal animal model. Neurourol Urodyn. 12(3):241-52;
Yamanishi T, Yasuda K, Sakakibara R, Suda S, Ishikawa N, Hattori T, Hosaka H. (1999) Induction of urethral closure and inhibition of bladder contraction by continuous magnetic stimulation. Neurourol Urodyn. 18(5):505-10.
Dr. Peters (2010) published the results of a retrospective chart review from November 2003 to June 2008 of patients (n=67, 80.6% female, 19.4% male, mean age: 54.5 years) with pudendal nerve lead placement. Primary diagnoses were interstitial cystitis/PBS (n=26), urgency/frequency or urge UI (n=29), urinary retention (n=9), pelvic pain (n=2), and tethered sacral cord (n=1). Three patients had peripheral neuropathy. With a mean follow-up of 32.3 months, over 90% of patients who failed SNS responded to PNS. Complications included superficial wound infections, pain (back pain, leg pain, sciatic pain and shocks), reoperations for lead replacement, migration, etc.
Dr. Peters feels that ONS is an alternative to sacral stimulation, it stimulates S2, S3, and S4, is more desired than sacral and salvages >90% of sacral failures. However, there is no multicenter pivotal trial and it does not have widespread adoption.
Peters KM, Killinger KA, Boguslawski BM, Boura JA. (2010) Chronic pudendal neuromodulation: expanding available treatment options for refractory urologic symptoms. Neurourol Urodyn. 29(7):1267-71
Figure 3.
The best portion of Dr. Peters lecture was on percutaneous tibial nerve stimulation (PTNS). The tibial nerve sends afferents through the sacral nerve plexus and has been studied since the 1980s for the treatment of OAB but only recently have there been controlled trials (Peters, 2010). The procedure involves locating the posterior tibial nerve above the medial malleolus and inserting a 34-gauge, percutaneous solid needle several inches (see Figure). A ground surface electrode is placed over the ipsilateral calcaneus. The needle is connected to a low-voltage stimulator. Stimulation of the nerve results in a sensory response causing a tickling sensation in the sole of the big toe and a motor response causing plantar flexion of the big toe and fanning of the remaining toes. If the big toe bends downward with stimulation, the needle’s placement is ideal.
Peters (2009) enrolled subjects (n=100) with OAB who were randomized to either treatment with tolterodine-ER or PTNS. A 12 week trial demonstrated comparable effectiveness from a Global Response Assessment of weekly PTNS (79.5% improved or cured) to extended-release tolterodine (54.8% improved or cured). Greater than 95% of subjects maintained their objective and subjective response of decreased urinary frequency at 6 and 12 months.
Peters KM, Macdiarmid SA, Wooldridge LS, Leong FC, Shobeiri SA, Rovner ES, Siegel SW, Tate SB, Jarnagin BK, Rosenblatt PL, Feagins BA (2009)
Randomized trial of percutaneous tibial nerve stimulation versus extended-release tolterodine: results from the overactive bladder innovative therapy trial. J Urol. 182(3):1055-61.
Figure 4.
The most recent PTNS study (SUmiT= The Study of Urgent® PC vs. Sham Effectiveness in Treatment of Overactive Bladder Symptoms) was an intent-to-treat multi-center study to assess the efficacy of PTNS therapy compared to validated inactive sham therapy in women and men (n=220) with OAB symptoms. Subjects received 12 weekly 30-minute therapy sessions. The sham consisted of 2 inactive surface electrodes placed on the subject’s foot to mimic the sham therapy – one under subjects' little toes and one of top of the foot. The primary endpoint was a determined by moderate or marked improvement on a seven-level Global Response Assessment (GRA) and is shown in Figure 4.
The researchers concluded that this multi-center, double-blind, sham-controlled trial provides Level I clinical evidence that the therapeutic effect of PTNS is not due to a placebo effect but rather to stimulation of the tibial nerve with significant improvement in OAB symptoms. PTNS is effective, lacks major side effects and may be considered a primary treatment for OAB symptoms.
Peters KM, Carrico DJ, Perez-Marrero RA, Khan AU, Wooldridge LS, Davis GL, Macdiarmid SA. (2010) Randomized trial of percutaneous tibial nerve stimulation versus Sham efficacy in the treatment of overactive bladder syndrome: results from the SUmiT trial. J Urol. 183(4):1438-43.
Finazzi-Agrò (2010) published a prospective, double-blind, placebo controlled study, based on an original placebo technique, performed to evaluate the efficacy of percutaneous tibial nerve stimulation in female patients (n=35) with detrusor overactivity incontinence. Although a smaller number of subjects, conclusions were similar to the peters (2010) study. PTNS was effective with 71% of patients considered responders, while none of those treated with placebo were considered responders. They concluded that the relevance of a placebo effect seems to be negligible in this patient population.
Finazzi-Agrò E, Petta F, Sciobica F, Pasqualetti P, Musco S, Bove P. (2010) Percutaneous tibial nerve stimulation effects on detrusor overactivity incontinence are not due to a placebo effect: a randomized, double-blind, placebo controlled trial. J Urol. 184(5):2001-6.
Presented by Kenneth M. Peters, MD at the 7th Pan Arab Continence Society (PACS) Annual Meeting - February 3 - 5, 2011 - Dubai, United Arab Emirates
Reported for UroToday by Diane K. Newman, RNC, MSN, CRNP, FAAN and Continence Nurse Practitioner Specialist - University of Pennsylvania Medical Center.
REPRINTED WITH PERMISSION OF UROTODAY! Read the full article at: http://www.urotoday.com/index.php?op...2567&Itemid=26
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