Two-Year Outcomes of Sacral Neuromodulation Versus OnabotulinumtoxinA for Refractory Urgency Urinary Incontinence: A Randomized Trial

Amundsen, Cindy L.; Komesu, Yuko M.; Chermansky, Christopher; Gregory, W. Thomas; Myers, Deborah L.; Honeycutt, Emily; Vasavada, Sandip P.; Nguyen, John N.; Wilson, Timothy H.; Harvie, Heidi S.; Wallace, Dennis

doi:10.1016/j.eururo.2018.02.011

Cited by 110 publications

(97 citation statements)

References 15 publications

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“…Using the standardized tined lead placement technique with the curved and straight stylet, we observed success rates on ITT analyses of 91% and 45%, respectively. The straight stylet data are in line with published data , but the curved stylet data are clearly higher than previously reported. Since patient screening was the same throughout the study, patient selection seems an unlikely explanation of the differences.…”

Section: Discussionsupporting

confidence: 91%

“…Success rates after the 2–3 years of follow‐up reported by well‐designed multicentre prospective studies vary from 50% to 76% in per‐protocol analyses . Unfortunately, there is a lack of clarity in the results of true intention‐to‐treat (ITT) analyses from those studies, incorporating all patients that were screened with the SNM tests.…”

Section: Introductionmentioning

confidence: 99%

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Sacral neuromodulation using the standardized tined lead implantation technique with a curved vs a straight stylet: 2‐year clinical outcomes and sensory responses to lead stimulation

et al. 2019

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Objectives To assess clinical follow‐up data over 24 months, comparing the use of a curved vs straight stylet in patients undergoing sacral neuromodulation using the standardized tined lead implantation technique. Patients and Methods We conducted a single tertiary‐centre, prospective study between August 2013 and June 2015 involving 40 patients with overactive bladder and 15 with non‐obstructive urinary retention refractory to first‐line treatment. The primary outcome was successful tined lead procedure according to intention‐to‐treat analyses at 12 and 24 months. The secondary outcome was number of optimal electrode configurations during programming. Statistical analysis was performed using plain non‐parametric tests for numerical and categorical data. Results Successful tined lead procedures were achieved in 33 of 35 patients (94%) implanted with the curved stylet compared with 13 of 20 patients (65%) implanted with the straight stylet (P = 0.005). Intention‐to‐treat analyses at 12 and 24 months showed success rates of 94% and 91%, respectively, in the curved stylet group vs 65% and 45%, respectively, in the straight stylet group (P = 0.002 and P < 0.001). In the curved stylet group, 60% and 25% of the electrode configurations were considered optimal and poor, respectively, vs 40% and 37%, respectively, in the straight stylet group (P < 0.001). Conclusions The use of the standardized implantation technique with the curved stylet led to more successful tined lead procedures, better success rates after 2 years of follow‐up and a greater number of optimal electrode configurations when compared to use of the straight stylet.

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Section: Discussionsupporting

confidence: 91%

Section: Introductionmentioning

confidence: 99%

Sacral neuromodulation using the standardized tined lead implantation technique with a curved vs a straight stylet: 2‐year clinical outcomes and sensory responses to lead stimulation

et al. 2019

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“…Programming and reprogramming are important but often neglected parts in the treatment of patients with SNM. Nevertheless (re)programming is regularly required as the average frequency reported is twice a year the first 2 years after implantation . The most common reasons for (re)programming are lack or loss of efficacy and undesirable stimulation.…”

Section: Discussionmentioning

confidence: 99%

Repeatability of tools to assist in the follow up and troubleshooting of sacral neuromodulation patients using the sensory response

Vaganée¹,

Borne²,

Fransén

et al. 2019

Neurourology and Urodynamics

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Purpose Sacral neuromodulation (SNM) is an established minimally invasive therapy for functional disorders of the pelvic organs in which electrodes are stimulated in proximity of the sacral spinal nerves. Reprogramming of the electrodes is regularly required and is based on the sensory response. This study assesses the repeatability of a pelvic chart and grading system to enable a more objective assessment of the sensory response upon electrode stimulation. Material and Methods In 26 SNM patients, with OAB or NOUR, assessment of the sensory response was done using the sensory threshold (ST) and a pelvic chart with 1 cm2 coordinates, each coordinate corresponding with a dermatome and location of sensation (LoS). A grading system was developed based upon the ST and LoS. Repeatability of ST was assessed using a two‐way mixed effects, absolute agreement, single rater/measurement intraclass correlation coefficient (ICC), and displayed using a correlation and Bland Altman plot. Repeatability of dermatomes, LoS, and grading system was assessed using kappa correlation coefficient. Results On average, 1.55 ± 0.85 coordinates were used to point out the area where the stimulation was perceived. The mean amount of coordinates between the area pointed at during the first and second measurement was 0.47 ± 0.74. ST showed excellent repeatability (ICC 0.93, 95%CI 0.90‐0.94, P < 0.001). Dermatomes, LoS and grading system showed a substantial to almost perfect agreement (κ = 0.740‐0.833, P < 0.001). Conclusions The pelvic chart and grading system, using the sensory response upon electrode stimulation, are repeatable tools and can be used to assist in follow up and troubleshooting of SNM patients.

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“…Patients were included in this study if they had more than eight episodes of urgency per day and/or more than two episodes of urge incontinence per day. In the Rosetta trial, comparing short term outcomes between SNS and intravesical onbotulinumtoxinA injection, 87% (169/194) of the patients in the SNS arm were classified as clinical responders, defined as a greater than 50% reduction in urgency symptoms . Despite the promise of this therapy in the clinical trial setting, results from a “real world” representation of the general population show different results.…”

Section: Discussionmentioning

confidence: 99%

“…In the Rosetta trial, comparing short term outcomes between SNS and intravesical onbotulinumtoxinA injection, 87% (169/194) of the patients in the SNS arm were classified as clinical responders, defined as a greater than 50% reduction in urgency symptoms. 12 Despite the promise of this therapy in the clinical trial setting, results from a "real world" representation of the general population show different results. A national analysis of Medicare and private insurance claims data shows that 45.8% to 51% of the patients proceeded to the second stage.…”

Section: Figure 1 One Versus Two Stage Costsmentioning

confidence: 99%

Comparative effectiveness of one versus two‐stage sacral neurostimulation device placement

Patel

Zhao

Houman

et al. 2019

Neurourology and Urodynamics

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Objective Sacral neurostimulation (SNS) is an effective third‐line treatment for overactive bladder. We sought to compare the cost of standard two‐stage SNS device placement to that of a combined one‐stage placement using a Markov chain model. Methods Costs were defined using Medicare outpatient reimbursement rates. The model was developed as follows: With the two‐stage approach, patients underwent initial lead placement with fluoroscopy and those who converted to stage two underwent permanent generator placement week later. Patients who did not convert underwent lead removal. Patients undergoing a one‐stage procedure had initial lead and generator placement at the same time. Patients with success underwent no further procedure. Patients without success could opt for generator and lead removal. Cost effectiveness of one versus two‐stage placement depended on successful conversion rate. Results Reimbursement included physician, anesthesia, facility and device fees. In a two‐stage procedure, initial cost of lead placement was $6170. With successful conversion, cost of a second procedure with permanent lead and generator placement was $18,474. Patients who failed test phase underwent lead removal for a cost of $2879. In a one‐stage procedure approach, initial cost of permanent lead and generator placement was $18,474. Patients with a successful outcome had no additional costs. Patients with an unsuccessful outcome could have the lead and generator removal for a cost of $5758. If the conversion rate from testing phase to permanent placement was greater than 71%, a one‐stage approach proved to be cost effective. Conclusions Identifying patients with favorable risk factors for success may predict those patients who warrant a one‐stage approach.

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Two-Year Outcomes of Sacral Neuromodulation Versus OnabotulinumtoxinA for Refractory Urgency Urinary Incontinence: A Randomized Trial

Cited by 110 publications

References 15 publications

Sacral neuromodulation using the standardized tined lead implantation technique with a curved vs a straight stylet: 2‐year clinical outcomes and sensory responses to lead stimulation

Sacral neuromodulation using the standardized tined lead implantation technique with a curved vs a straight stylet: 2‐year clinical outcomes and sensory responses to lead stimulation

Repeatability of tools to assist in the follow up and troubleshooting of sacral neuromodulation patients using the sensory response

Comparative effectiveness of one versus two‐stage sacral neurostimulation device placement

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