Sacral neuromodulation: standardized tined lead implantation technique: two-year clinical outcome and sensory response upon lead stimulation comparing the use of the curved versus straight stylet

OBJECTIVES To assess clinical follow-up data over 24 months using the standardized tined lead implantation technique, comparing the use of the curved vs straight stylet. PATIENTS AND METHODS Single tertiary center, prospective study (August 2013 - June 2015) involving 40 patients with overactive bladder and 15 with non-obstructive urinary retention refractory to first-line treatment. PRIMARY OUTCOME successful tined lead procedure; intention to treat analysis at 12 and 24 months. Secondary outcome: number of optimal electrode configurations during programming. Statistical analysis was performed by plain non-parametric tests for numeric and categorical data. RESULTS 33/35 (94%) patients implanted with the curved stylet had a successful tined lead procedure versus 13/20 (65%) implanted with the straight stylet (p=0.005). Intention to treat analysis at 12 and 24 months was 94% and 91% for the patients with the curved stylet compared to 65% and 45% for those with the straight stylet (p=0.002 and p<0.001). 60% and 25% of the electrode configurations in the curved group were considered optimal and bad in comparison to 40% and 37% in the straight group (p<0.001). The main limitation is the non-randomized study design. CONCLUSIONS The use of the standardized implantation technique with the curved stylet leads to more successful tined lead procedures, better success rates after 2-years follow-up and more optimal electrode configurations when compared to use of the straight stylet placement. This article is protected by copyright. All rights reserved

Pelvic floor muscle electromyography as a guiding tool during lead placement and (re)programming in sacral neuromodulation patients : validity, reliability, and feasibility of the technique

Purpose To assess the validity, reliability, and feasibility of electromyography (EMG) as a tool to measure pelvic floor muscle (PFM) contractions during placement and (re)programming of the tined lead electrodes in sacral neuromodulation (SNM) patients. Materials and Methods Single tertiary center, prospective study conducted between 2017 and 2019 consisting of three protocols including a total of 75 patients with overactive bladder (wet/dry) or nonobstructive urinary retention. PFM EMG was recorded using the multiple array probe (MAPLe), placed intravaginally. All stimulations (monophasic pulsed square wave, 210 mu sec, 14 Hz) were performed using Medtronic's standard SNM stimulation equipment. During lead implantation, all four lead electrodes were stimulated with fixed increasing stimulation intensities (1-2-3-5-7-10 V). During lead electrode (re)programming, five bipolar lead electrode configurations were stimulated twice up to when an electrical PFM motor response (EPFMR), sensory response, and pain response were noted (i.e., the threshold), respectively. Additionally, amplitude and latency of the EPFMRs were determined. Validity, reliability, and feasibility were statistically analyzed using the intraclass correlation coefficient, weighted Cohen's kappa and linear regression, respectively. Results Validity: EPFMRs were strongly associated with visually detected PFM motor responses (kappa= 0.90). Reliability: EPFMR amplitude (ICC = 0.99) and latency (ICC = 0.93) showed excellent repeatability. Feasibility: linear regression (EPFMR threshold = 0.18 mA + 0.76 * sensory response threshold) showed an increase in the sensory response threshold is associated with a smaller increase in EPFMR threshold, with the EPFMR occurring before or on the sensory response threshold in 83.8% of all stimulations. Conclusions Measuring PFM contractions with EMG during placement and (re)programming of lead electrodes in SNM patients is valid, reliable, and feasible. Therefore, the use of PFM EMG motor responses could be considered as a tool to assist in these procedures.Neuro-urology: functional disorders in male and female urogenital trac

Pelvic floor activation upon stimulation of the sacral spinal nerves in sacral neuromodulation patients

Purpose To assess the activation of the different parts of the pelvic floor muscles (PFM) upon electrical stimulation of the sacral spinal nerves while comparing the different lead electrode configurations. Material and Methods PFM electromyography (EMG) was recorded using an intravaginal multiple array probe with 12 electrodes pairs, which allows to make a distinction between the different sides and depths of the pelvic floor. In addition concentric needle EMG of the external anal sphincter was performed to exclude far-field recording. A medtronic InterStim tined lead (model 3889) was used as stimulation source. Standard SNM parameters (monophasic pulsed square wave, 210 microseconds, 14 Hz) were used to stimulate five different bipolar electrode configurations (3+0-/3+2-/3+1-/0+3-/1+3-) up to and around the sensory threshold. Of each EMG signal the stimulation intensity needed to evoke the EMG signals as well as its amplitude and latency were determined. Linear mixed models was used to analyse the data. Results Twenty female patients and 100 lead electrode configurations were stimulated around the sensory response threshold resulting in 722 stimulations and 12 times as many (8664) EMG recordings. A significant increase in EMG amplitude was seen upon increasing stimulation intensity (P posterior>anterior>contralateral) and depths (deep>center>superficial) of the pelvic floor. These differences were noted for all lead electrodes configurations stimulated (P .05). Conclusions A distinct activation pattern of the PFM could be identified for all stimulated lead electrode configurations. Electrical stimulation with the most proximal electrode (electrode #3) as the active one elicited the largest PFM contractions.Neuro-urology: functional disorders in male and female urogenital trac

Pelvic floor activation upon stimulation of the sacral spinal nerves in sacral neuromodulation patients

Purpose To assess the activation of the different parts of the pelvic floor muscles (PFM) upon electrical stimulation of the sacral spinal nerves while comparing the different lead electrode configurations. Material and Methods PFM electromyography (EMG) was recorded using an intravaginal multiple array probe with 12 electrodes pairs, which allows to make a distinction between the different sides and depths of the pelvic floor. In addition concentric needle EMG of the external anal sphincter was performed to exclude far-field recording. A medtronic InterStim tined lead (model 3889) was used as stimulation source. Standard SNM parameters (monophasic pulsed square wave, 210 microseconds, 14 Hz) were used to stimulate five different bipolar electrode configurations (3+0-/3+2-/3+1-/0+3-/1+3-) up to and around the sensory threshold. Of each EMG signal the stimulation intensity needed to evoke the EMG signals as well as its amplitude and latency were determined. Linear mixed models was used to analyse the data. Results Twenty female patients and 100 lead electrode configurations were stimulated around the sensory response threshold resulting in 722 stimulations and 12 times as many (8664) EMG recordings. A significant increase in EMG amplitude was seen upon increasing stimulation intensity (P posterior>anterior>contralateral) and depths (deep>center>superficial) of the pelvic floor. These differences were noted for all lead electrodes configurations stimulated (P .05). Conclusions A distinct activation pattern of the PFM could be identified for all stimulated lead electrode configurations. Electrical stimulation with the most proximal electrode (electrode #3) as the active one elicited the largest PFM contractions.Neuro-urology: functional disorders in male and female urogenital trac

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

Purpose: Sacral neuromodulation (SNM) is an established minimally invasivetherapy for functional disorders of the pelvic organs in which electrodes arestimulated in proximity of the sacral spinal nerves. Reprogramming of the electrodesis regularly required and is based on the sensory response. This study assesses therepeatability of a pelvic chart and grading system to enable a more objectiveassessment of the sensory response upon electrode stimulation.Material and Methods: In 26 SNM patients, with OAB or NOUR, assessment ofthe sensory response was done using the sensory threshold (ST) and a pelvic chartwith 1 cm2 coordinates, each coordinate corresponding with a dermatome andlocation of sensation (LoS). A grading system was developed based upon the STand 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 ofdermatomes, LoS, and grading system was assessed using kappa correlationcoefficient.Results: On average, 1.55 ± 0.85 coordinates were used to point out the area wherethe stimulation was perceived. The mean amount of coordinates between the areapointed at during the first and second measurement was 0.47 ± 0.74. ST showedexcellent repeatability (ICC 0.93, 95%CI 0.90-0.94, P and grading system showed a substantial to almost perfect agreement (κ = 0.740-0.833, P Conclusions: The pelvic chart and grading system, using the sensory response uponelectrode stimulation, are repeatable tools and can be used to assist in follow up andtroubleshooting of SNM patients.Neuro-urology: functional disorders in male and female urogenital trac