Aims This prospective multicenter observational study evaluated postprostatectomy incontinence treatment outcomes with Virtue male sling at 12 and 36 months. Methods Objective assessment was based... Show moreAims This prospective multicenter observational study evaluated postprostatectomy incontinence treatment outcomes with Virtue male sling at 12 and 36 months. Methods Objective assessment was based on a 24-h pad weight test with improvement defined by a decrease >50% and cure by less than 1.3 g. Subjective assessment was based on the patient global impression of improvement and International Consultation on Incontinence Questionnaire-urinary incontinence-short form (ICIQ-UI-SF) questionnaires. Subgroups were analyzed by baseline severity of incontinence on a 24-h-pad test, body mass index (BMI), and pads usage. Factors associated with treatment response were assessed using logistic regression at Months 36. Complications were reported. Results We analyzed data from 117 men. Objective and subjective improvement were achieved in 54% and 35% and 51% and 34% at 12 and 36 months, respectively. Twenty-one percent and 19% were considered cured, respectively, at 12 and 36 months. No differences per baseline incontinence severity, BMI and pads usage were found at 36 months. Mean ICIQ-UI-SF score decreased from 15 to 9. Predictive factors were BMI, postvoid residual urine, number of nighttime urination, and ICIQ total score. Seven Clavien-Dindo Grade III (5.1%) including four Virtue sling revisions were reported. The most frequent Grade II complications were overactive bladder symptoms and pain reported in 10.3% and 2.9%, respectively. No complications required explantation. Conclusions Virtue male sling is safe and effective in males with mild to severe postprostatectomy urinary incontinence over 36 months. Virtue could be considered an interesting option for postradical prostatectomy urinary incontinence with positive results over time even in patients with high BMI. The predictive model should be validated by further studies. Show less
Vaganee, D.; Voorham, J.; Borne, S. van de; Voorham-van der Zalm, P.; Fransen, E.; Wachter, S. de 2020
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... Show morePurpose 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 < .0001). Large differences were noted between the EMG amplitude recorded at the different sides (ipsilateral>posterior>anterior>contralateral) and depths (deep>center>superficial) of the pelvic floor. These differences were noted for all lead electrodes configurations stimulated (P < .0001). Larger EMG amplitudes were measured when the active electrode was located near the entry point of the sacral spinal nerves through the sacral foramen (electrode #3). No differences in EMG latency could be withheld, most likely due to the sacral neuroanatomy (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. Show less
Vaganee, D.; Voorham, J.; Panicker, J.N.; Fransen, E.; Voorham-van der Zalm, P.; Borne, S. van de; Wachter, S. de 2020
Background In sacral neuromodulation (SNM) patients, it is thought the bellows response elicited upon sacral spinal nerve stimulation is reflex-mediated. Therefore the mechanism of action of SNM is... Show moreBackground In sacral neuromodulation (SNM) patients, it is thought the bellows response elicited upon sacral spinal nerve stimulation is reflex-mediated. Therefore the mechanism of action of SNM is considered to be at the spinal or supraspinal level. These ideas need to be challenged.Objective To identify the neural pathway of the bellows response upon sacral spinal nerve stimulation.Design, Setting, and Participants Single tertiary center, prospective study (December 2017-June 2019) including 29 patients with overactive bladder refractory to first-line treatment.Intervention Recording of the pelvic floor muscle response (PFMR) using a camcorder and electromyography (EMG) (intravaginal probe and concentric needles) upon increasing stimulation during lead or implantable pulse generator placement.Outcome Measurements and Statistical Analysis The lowest stimulation intensity needed to elicit a visual PFMR and electrical PFMR was determined. Electrical PFMRs were subdivided according to their latency.Outcome: the association between visual and electrical PFMRs. Statistical analyses were performed using the weighted kappa coefficient.Results Three different electrical PFMRs could be identified by surface and needle EMG, corresponding with a direct efferent motor response (R1), oligosynaptic (R2), and polysynaptic (R3) afferent reflex response.Only the R1 electrical PFMR was perfectly associated with the visual PFMR (kappa = 0.900).Conclusions The visual PFMRs upon sacral spinal nerve stimulation are direct efferent motor responses. A reopening of the discussion on the mechanism of action of SNM is possibly justified. Show less
Introduction Past research has demonstrated that the urethral tonus is mainly under sympathetic control. Since 5 years, a beta 3-adrenoceptor (ADRB3) agonist is available in the treatment of... Show moreIntroduction Past research has demonstrated that the urethral tonus is mainly under sympathetic control. Since 5 years, a beta 3-adrenoceptor (ADRB3) agonist is available in the treatment of overactive bladder syndrome. The presence of ADRB3 within the human urethra has not been demonstrated to date. Presence of ADRB3 in the urethra could influence urethral tonus. The aim of this study is to investigate the presence of ADRB3 in the human female urethra. Material and Methods We performed anatomical studies in five female specimens. Three specimens were obtained from the body donation program, two from female patients with muscle-invasive bladder cancer, where radical resection of bladder and urethra was performed. The urethra up till the bladder neck was separated from the rest of the bladder and freshly obtained for this study. For demonstrating ADRB3 expression, we used rabbit polyclonal anti-human ADRB3 LS-A4198. Results Expression of ADBR3 was demonstrated in the epithelial layer of all urethral parts, except at the level of the meatus. The level of ADRB3 expression was highest in the mid urethra. There was no direct contact between ADRB3 and nerve tissue. ADRB3 expression was also demonstrated in the stratified muscle layer at the level of the external urethral sphincter. Conclusions This is the first study to demonstrate the expression of ADRB3 in the human female urethra. There is an absence of a direct connection between ADRB3 and nerve tissue. Show less
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... Show morePurpose 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 cm(2) 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 (kappa = 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. Show less
Vaganee, D.; Borne, S. van de; Fransen, E.; Voorham, J.; Voorham-van der Zalm, P.; Wachter, S. de 2019
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... Show morePurpose: 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 < 0.001). Dermatomes, LoSand 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 uponelectrode stimulation, are repeatable tools and can be used to assist in follow up andtroubleshooting of SNM patients. Show less
Voorham, J.C.; Wachter, S. de; Bos, T.W.L. van den; Putter, H.; Nijeholt, G.A.L.A.; Voorham-van der Zalm, P.J. 2017
