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Abdullah A Gahzi, Dean S Elterman, Magdy Hassouna
The objective of this study was to describe our experience using sacral neuromodulation to treat urinary urgency, frequency, urge incontinence, and chronic urinary retention in patients with cardiac pacemakers. With the increasingly widespread use of InterStim for bladder function restoration, we are seeing more complex patients with multiple comorbidities, including cardiac conditions. Herein, we report 3 cases of individuals with cardiac pacemakers who underwent InterStim implantation to treat urinary conditions...
September 2016: International Neurourology Journal
Mai Banakhar, Magdy Hassouna
PURPOSE: InterStim device is an U.S. Food and Drug Administration approved minimal invasive therapy for sacral neuromodulation for lower urinary tract dysfunction. Before InterStim implantation, a trial with the appropriate screening tests is required to determine patient therapy eligibility. There are two different techniques for patient screening: percutaneous nerve evaluation (PNE) test and staged test. Few studies have reported success and failure rates for each technique. However, test sensitivity and predictive values of either test have not been studied...
September 2016: International Neurourology Journal
Matthew E Sterling, Siobhan M Hartigan, Alan J Wein, Ariana L Smith
INTRODUCTION: Explantation of the Interstim sacral neuromodulation (SNM) device is occasionally necessary. Removing the tined lead can put strain on the lead, resulting in a possible break and retained fragments. The Food and Drug Administration (FDA) released a notification regarding health consequences related to retained lead fragments. We describe a novel and safe surgical technique for removing the Interstim device and permanent lead. MATERIALS AND METHODS: We searched the Manufacturer and User Facility Device Experience (MAUDE) database for complications related to tined lead removal and searched the database of a single surgeon at our institution...
October 2016: Canadian Journal of Urology
Karen Noblett, Kevin Benson, Karl Kreder
INTRODUCTION: The InSite trial is a prospective, multicenter study of sacral neuromodulation (SNM) therapy with the InterStim® System in subjects with overactive bladder (OAB). One of the primary aims of the study is to report on long-term safety of the tined lead. This analysis provides detailed descriptions of device-related adverse events (AEs) and surgical interventions to 12 months. METHODS: Analysis included those subjects who completed test stimulation with a tined lead, received a full implant, and reported device-related AEs out to 12 months...
August 4, 2016: Neurourology and Urodynamics
Kathryn Griffin Cunningham, O Lenaine Westney
INTRODUCTION: Sacral chordoma is a rare malignant tumor arising from remnants of the notochord. Due to its propensity for recurrence, the treatment of choice is surgical resection. Orthopedic and neurosurgical literature describe bladder dysfunction as prevalent in these patients, specifically urinary incontinence, however urologic literature is lacking in the exact nature of this dysfunction. Thus far, Sacral Nerve Stimulation (SNS) has not been described as a treatment option for these patients...
June 13, 2016: Neuromodulation: Journal of the International Neuromodulation Society
Steven Siegel, Karen Noblett, Jeffrey Mangel, Tomas L Griebling, Suzette E Sutherland, Erin T Bird, Craig Comiter, Daniel Culkin, Jason Bennett, Samuel Zylstra, Fangyu Kan, Elizabeth Thiery
OBJECTIVE: To evaluate the therapeutic success rate, and changes in quality of life (QOL) and safety in subjects using sacral neuromodulation (InterStim System) at 36 months. Subjects with bothersome symptoms of overactive bladder (OAB) including urinary urge incontinence (UI) and/or urgency frequency (UF), who had failed at least 1 anticholinergic medication, and had at least 1 untried medication were included. METHODS: Subjects with successful test stimulation received an InterStim implant...
August 2016: Urology
Muhannad Alsyouf, Mohamed Keheila, Michelle Marinone, Allie Blackburn, Andrea Staack
Patients undergoing InterStim implantation often have comorbidities, which require magnetic resonance imaging (MRI) for diagnosis. Although MRI of the head has been recently approved for use with the InterStim neurostimulator, imaging of other regions remains controversial. We present a case of Achilles tendinitis diagnosed on MRI of the ankle in a patient with an InterStim device. The neurostimulator was deactivated, and using a transmit/receive extremity coil, the left ankle was imaged without any adverse events...
February 2016: Canadian Journal of Urology
Laura Alonso Guardo, Carlos Cano Gala, David Sánchez Poveda, Pablo Rueda Juan, Francisco José Sánchez Montero, José Carlos Garzón Sánchez, Juan Ignacio Santos Lamas, Miguel Vicente Sánchez Hernández
BACKGROUND: Sacral nerve stimulation is a therapeutic option with demonstrated efficacy for conditions presenting with perineal pain caused by different etiologies. We aimed to assess whether a sacral electrode (InterStim®, Medtronic, Minneapolis, MN, USA) inserted through the caudal pathway is able to offer an acceptable level of sacral stimulation and rate of catheter migration. METHODS: We present 12 patients with pelvic pain who received sacral neuromodulation via the sacral hiatus with the InterStim electrode...
January 2016: Korean Journal of Pain
Nagendra Nath Mishra
Bladder pain syndrome/interstitial cystitis (BPS/IC) is a chronic disease characterized by pelvic pain urgency and frequency. Patients with severe symptoms lead a very miserable life. North American, European and Asian guidelines have been recently promulgated but they differ on many important issues. There is no consensus on its name, definition, investigations and management. Indian guidelines have also been developed and they give more importance to the symptoms in relation to micturition. Though initially believed to be rare or non-existent in India the situation has changed...
October 2015: Translational Andrology and Urology
Emilie Duchalais, Guillaume Meurette, Bastien Perrot, Vincent Wyart, Caroline Kubis, Paul-Antoine Lehur
PURPOSE: The efficacy of sacral nerve stimulation in faecal incontinence relies on an implanted pulse generator known to have a limited lifespan. The long-term use of sacral nerve stimulation raises concerns about the true lifespan of generators. The aim of the study was to assess the lifespan of sacral nerve stimulation implanted pulse generators in daily practice, and the outcome of exhausted generator replacement, in faecal incontinent patients. METHODS: Faecal incontinent patients with pulse generators (Medtronic Interstim™ or InterstimII™) implanted in a single centre from 2001 to 2014 were prospectively followed up...
February 2016: International Journal of Colorectal Disease
Danielle Markle Price, Karen Noblett
OBJECTIVES: The aim of this study was to assess a difference in efficacy and patient preference in cyclic versus continuous stimulation with InterStim therapy for urge incontinence or urinary frequency. METHODS: Patients with refractory urge incontinence/urinary frequency and with recent implantation of the InterStim system were randomized to continuous or cyclic InterStim stimulation after institutional review board-approved consent. They completed a 3-day voiding diary after 1 month of stimulation...
November 2015: Female Pelvic Medicine & Reconstructive Surgery
Jason P Gilleran, Kim Killinger, Judith Boura, Kenneth M Peters
OBJECTIVES: To determine: (1) if obtaining motor response on <4 tined lead electrodes at time of placement affects subjective and objective clinical outcome and (2) voltage requirements to elicit motor response at implant and first postoperative visit number based on number of responding electrodes. METHODS: We reviewed our prospective neuromodulation database to identify patients with unilateral S3 lead placement and motor response (bellows ± toe flexion) on stimulation of 1-4 electrodes, then grouped by number of active electrodes at lead placement...
June 2016: Neurourology and Urodynamics
Melissa A Laudano, Stephan Seklehner, Jaspreet Sandhu, W Stuart Reynolds, Kelly A Garrett, Jeffrey W Milsom, Alexis E Te, Steven A Kaplan, Bilal Chughtai, Richard K Lee
PURPOSE: Sacral neuromodulation with the InterStim® has been done to treat urinary and bowel control. There are limited data in the literature on use trends of sacral neuromodulation. We explored disparities in use among Medicare beneficiaries. MATERIALS AND METHODS: We queried a 5% national random sample of Medicare claims for 2001, 2004, 2007 and 2010. All patients with an ICD-9 diagnosis code representing a potential urological indication for sacral neuromodulation were included...
August 2015: Journal of Urology
Daniel K Chan, Matthew A Barker
BACKGROUND: Dyssynergic defecation is a complex bowel problem that leads to chronic constipation and abdominal pain. Management is often challenging owing to the incoordination of multiple pelvic floor muscles involved in normal defecation. CASE: We report a case of dyssynergic defecatory dysfunction in a patient with cerebral palsy treated with sacral neuromodulation. At presentation, Sitz marker study and magnetic resonance defecography showed evidence of chronic functional constipation...
May 2015: Female Pelvic Medicine & Reconstructive Surgery
Thaddeus S Brink, Patrick L Zimmerman, Melissa A Mattson, Xin Su, Dwight E Nelson
PURPOSE: Sacral neuromodulation is a Food and Drug Administration approved therapy for urinary urge incontinence, urgency-frequency and fecal incontinence. Most preclinical studies have used anesthetized preparations in small animals. To expand the testing capabilities of sacral neuromodulation stimulation parameters and novel concepts we created a large animal model in fully conscious sheep. MATERIALS AND METHODS: Six adult female sheep were tested weekly using 10 trials of single fill cystometry, similar to clinical urodynamics...
July 2015: Journal of Urology
Karen Noblett, Steven Siegel, Jeffrey Mangel, Tomas L Griebling, Suzette E Sutherland, Erin T Bird, Craig Comiter, Daniel Culkin, Jason Bennett, Samuel Zylstra, Fangyu Kan, Kellie Chase Berg
AIMS: This prospective, multicenter post-approval study evaluated the success rate of sacral neuromodulation (SNM) with the InterStim® System at 12-months. Subjects with bothersome symptoms of overactive bladder (OAB) including urinary urge incontinence (UI) or urgency-frequency (UF), who failed at least one anticholinergic medication and had at least one not tried were included. METHODS: Subjects with successful test stimulation received an SNM implant. Therapeutic success (≥50% improvement in average leaks/day or voids/day or a return to normal voiding frequency [<8 voids/day]) and quality of life through 12 months were evaluated for implanted subjects...
February 2016: Neurourology and Urodynamics
Mai Banakhar, Yahya Gazwani, Mohamed El Kelini, Tariq Al-Shaiji, Magdy Hassouna
INTRODUCTON: Sacral neuromodulation (SNM) has become an established therapy for voiding dysfunction. Additional benefits, such as improved bowel functions and bladder pain, have been reported. Improvement in female sexual function after SNM treatment has been suggested; however, reports examining the effects of SNM on female sexual functions are scarce. We evaluate the effects of SNM on female sexual function and its impact on quality of life and analyze any correlation. METHODS: Data were collected from January 2010 to May 2012 for all female patients who underwent SNM InterStim (Medtronic, Minneapolis, MN) therapy at a single centre in Canada...
November 2014: Canadian Urological Association Journal, Journal de L'Association des Urologues du Canada
Assia Valovska, Christian D Peccora, Cyril N Philip, Alan D Kaye, Richard D Urman
Pudendal neuralgia is a debilitating pain syndrome, and finding long-lasting treatment modalities has been challenging in pain management. The pudendal nerve has sensory and motor functions, and influences autonomic functions. Thus, entrapment or damage of this nerve can have multiple serious implications. The constellation of symptoms which result from injury to this nerve is commonly referred to as pudendal neuralgia. When conservative therapy does not provide adequate pain relief and surgical procedures fail or are not viable options, central and peripheral nerve stimulation can be effective treatment modalities...
September 2014: Pain Physician
Pamela June Levin, Nazema Yusuf Siddiqui, Jennifer Marie Wu, Cindy Louise Amundsen
OBJECTIVES: Sacral neuromodulation is a well-established treatment of refractory overactive bladder (OAB). Although literature exists on the psychosocial impact of other implanted medical devices, data do not exist for InterStim therapy. We aim to evaluate the relationship between optimism and treatment satisfaction in women undergoing InterStim for refractory OAB and change in OAB symptoms. METHODS: Adult women undergoing InterStim therapy for refractory OAB completed a series of validated questionnaires before test stimulation assessing optimism, urinary symptom severity, depression, and body image...
September 2014: Female Pelvic Medicine & Reconstructive Surgery
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