Purpose:We aimed to provide a real-world description of neurogenic lower urinary tract dysfunction within the first year after spinal cord injury with a focus on unfavorable urodynamic para...

We used clinical parameters to develop a prediction model for the occurrence of urodynamic risk factors for upper urinary tract (UUT) damage during the first year after acute spinal cord injury (SCI). A total of 97 patients underwent urodynamic investigation at 1, 3, 6, and 12 months after acute SCI, within the framework of a population-based longitudinal study at a single university SCI center. Candidate predictors included demographic characteristics and neurological and functional statuses 1 month after SCI. Outcomes included urodynamic risk factors for UUT damage: detrusor overactivity combined with detrusor sphincter dyssynergia, maximum storage detrusor pressure (pDetmax) ≥ 40 cmH₂O, bladder compliance < 20 mL/cmH₂O, and vesicoureteral reflux. Multivariable logistic regression was used for the prediction model development and internal validation, using the area under the receiver operating curve (aROC) to assess model discrimination. Two models showed fair discrimination for pDetmax ≥ 40 cmH₂O: (i) upper extremity motor score and sex, aROC 0.79 (95% CI: 0.69–0.89), C-statistic 0.78 (95% CI: 0.69–0.87), and (ii) neurological level, American Spinal Injury Association Impairment Scale grade, and sex, aROC 0.78 (95% CI: 0.68–0.89), C-statistic 0.76 (95% CI: 0.68–0.85). We identified two models that provided fair predictive values for urodynamic risk factors of UUT damage during the first year after SCI. Pending external validation, these models may be useful for clinical trial planning, although less so for individual-level patient management. Therefore, urodynamics remains essential for reliably identifying patients at risk of UUT damage.

Objective: To present the protocol for a randomized controlled trial (RCT) evaluating the efficacy and safety of transcutaneous tibial nerve stimulation (TTNS) for refractory neurogenic lower urinary tract dysfunction (NLUTD). Study Design and Results: bTUNED (bladder and TranscUtaneous tibial Nerve stimulation for nEurogenic lower urinary tract Dysfunction) is an international multicentre, sham‐controlled, double‐blind RCT investigating the efficacy and safety of TTNS. The primary outcome is success of TTNS, defined as improvements in key bladder diary variables at study end compared to baseline values. The focus of the treatment is defined by the Self‐Assessment Goal Achievement (SAGA) questionnaire. Secondary outcomes are the effect of TTNS on urodynamic, neurophysiological, and bowel function outcome measures, as well as the safety of TTNS. Conclusions: A total of 240 patients with refractory NLUTD will be included and randomized 1:1 into the verum or sham TTNS group from March 2020 until August 2026. TTNS will be performed twice a week for 30 min during 6 weeks. The patients will attend baseline assessments, 12 treatment visits and follow‐up assessments at the study end.

Transcutaneous tibial nerve stimulation (TTNS) is a promising treatment for neurogenic lower urinary tract symptoms. However, the evidence is limited due to a general lack of randomised controlled trials (RCTs) and, also, inconsistency in the sham and blinding conditions. In the context of much-needed RCTs, we aimed to develop a suitable sham-control protocol for a clinical setting to maintain blinding but avoid meaningful stimulation of the tibial nerve. Three potential electrode positions (lateral malleolus/5th metatarsal/plantar calcaneus) and two electrode sizes (diameter: 2.5 cm/3.2 cm) were tested to determine which combination provided the optimal sham configuration for a TTNS approach, based on a visible motor response. Sixteen healthy volunteers underwent sensory and motor assessments for each sham configuration. Eight out of them came back for an extra TTNS visit. Sensory thresholds were present for all sham configurations, with linear regression models revealing a significant effect regarding electrode position (highest at plantar calcaneus) but not size. In addition, motor thresholds varied with the position—lowest for the 5th metatarsal. Only using this position and 3.2 cm electrodes attained a 100% response rate. Compared to TTNS, sensory and motor thresholds were generally higher for the sham configurations; meanwhile, perceived pain was only higher at the lateral malleolus. In conclusion, using the 5th metatarsal position and 3.2 cm electrodes proved to be the most suitable sham configuration. Implemented as a four-electrode setup with standardized procedures, this appears to be a suitable RCT protocol for maintaining blinding and controlling for nonspecific TTNS effects in a clinical setting.

Background/Objectives: The objective of this study is to compare nerve-sparing (NS) and non-nerve-sparing (NNS) robot-assisted radical prostatectomy (RARP) techniques used to treat localized prostate cancer. Numerous studies have evaluated the impact of NS techniques on patient-reported outcomes. However, there are unaddressed methodological issues making interpretation of results difficult. Therefore, we performed a comparison of the two techniques, accounting for methodological threats, including patient selection and confounding. Methods: We sampled 120 patients with similar disease burden who underwent RARP by the same surgeon, either with NS (n = 84) or NNS (n = 36) and assessed changes in lower urinary tract (LUT) function and bother, and bowel function/bother using the Expanded Prostate Cancer Index Composite (EPIC) questionnaire and the six-item International Index of Erectile Function (IIEF-6) survey at 6 weeks and 12 months postoperatively. Multivariable linear regression models were used to adjust for differences in age, preoperative PSA levels, pathological tumor stage and Gleason-score of patients receiving either NS or NNS. Results: At 6 weeks postoperatively, the NNS group had a significantly larger decrease in LUT function compared to the NS group (−17.42; 95% Confidence Interval (CI): −31.31, −3.53; p = 0.0145). At 12 months, both groups recovered substantially, and no group differences were observed (p > 0.9). No significant differences were observed between the NS and NNS groups for the EPIC bowel subscores, whereas the IIEF-6 showed borderline significance at 12 months. Conclusions: The results suggest a small impact of NS vs. NNS RARP on important patient-reported outcomes when controlling for tumor biology, surgeon skill, and patient characteristics. These results need to be confirmed by larger studies using similar sampling strategies and design considerations.