Safety of ultrasound-guided percutaneous suprapubic catheter insertion in spinal cord injury patients.

STUDY DESIGN: Retrospective chart audit. OBJECTIVES: To evaluate the safety of ultrasound-guided percutaneous suprapubic catheter (SPC) insertion in patients with spinal cord injury/disease (SCI/D) and to attempt to identify risk factors for complications. SETTING: Specialized German centre for spinal cord injuries. METHODS: This retrospective chart analysis evaluated demographic, neurologic, and neuro-urologic data and the incidence and type of complications within the first 30 days after suprapubic bladder catheter insertion in SCI/D patients in the period between January 1st, 2013, and December 31st, 2022. RESULTS: The data of 721 SCI/D patients (244 women and 477 men, 386 tetraplegics and 355 paraplegics) were analysed. There were 44 complications (6.5%), of which 11 (1.5%) were major complications according to Clavien-Dindo ≥ 3. Among these were one small bowel injury and one peritoneal injury each, but no fatal complications. Regarding major complications (according to Clavien-Dindo ≥3), only patient age was identified as a risk factor (p = 0.0145). Gender, SCI/D level, neurological completeness, and severity of SCI/D or type of neurogenic lower urinary tract dysfunction (Odds ratio [95% CI] 1.6423 [0.4961;5.4361], 1.0421 [0.3152;3.4459], 0.3453 [0.0741;1.6101], 2.8379 [0.8567;9.4004] and 2.8095 [0.8097;9.7481] respectively) did not show any association with the frequency of major complications. CONCLUSIONS: Mild complications, especially temporary hematuria or infectious complications, are not uncommon after SPC insertion in SCI/D patients. Major complications occur only rarely, and no risk factor other than age could be detected. On this basis, pre-intervention education on informed consent for SCI/D patients can be provided on an evidence-based approach.

Bladder management, severity of injury and period of latency: a descriptive study on 135 patients with spinal cord injury and bladder cancer.

STUDY DESIGN: Longitudinal study. OBJECTIVES: To describe the severity of spinal cord injury/disease (SCI/D), type and management of neurogenic lower urinary tract dysfunction, tumor characteristics, and bladder cancer latency period in SCI/D patients. SETTING: Spinal cord injury centers in Germany, Austria, and Switzerland. METHODS: Data of SCI/D patients diagnosed with bladder cancer were collected between Jan 2012-Dec 2019 in the course of annual surveys in the neuro-urological departments of all 28 centers. Demographic and paralysis-specific data, data on the type and management of neurogenic lower urinary tract dysfunction, and histopathological tumor characteristics were collected. RESULTS: Regarding histopathological tumor characteristics, no significant differences were found in 135 individuals with SCI/D when stratified for bladder management without chronic catheterization, SCI/D severity, and ASIA classification. The mean latency period between the onset of SCI/D and the diagnosis of bladder cancer was significantly longer in patients with catheter-free emptying methods compared to patients with intermittent catheterization, and in patients with LMNL (Lower Motor Neuron Lesion) compared to patients with UMNL (Upper Motor Neuron Lesion). CONCLUSIONS: Urinary bladder carcinomas are late events in the long-term course of SCI/D. Follow-up and approaches to screening must therefore be intensified with increasing duration of long-term SCI.

Urinary bladder cancer as a late sequela of traumatic spinal cord injury.

BACKGROUND: Traumatic spinal cord injury (SCI) is also a combat-related injury that is increasing in modern warfare. The aim of this work is to inform medical experts regarding the different course of bladder cancer in able-bodied patients compared with SCI patients based on the latest medical scientific knowledge, and to present decision-making aids for the assessment of bladder cancer as a late sequela of traumatic SCI. METHODS: A study conducted between January 1998 and December 2019 in the BG Trauma Hospital Hamburg formed the basis for the decision-making aids. Urinary bladder cancer was diagnosed in 40 out of 7396 treated outpatient and inpatient SCI patients. General patient information, latency period, age at initial diagnosis, type of bladder management and survival of SCI patients with bladder cancer were collected and analysed. T category, grading and tumour entity in these patients were compared with those in the general population. Relevant bladder cancer risk factors in SCI patients were analysed. Furthermore, relevant published literature was taken into consideration. RESULTS: Initial diagnosis of urinary bladder cancer in SCI patients occurs at a mean age of 56.4 years (SD ± 10.7 years), i.e., approximately 20 years earlier as compared with the general population. These bladder cancers are significantly more frequently muscle invasive (i.e., T category ≥ T2) and present a higher grade at initial diagnosis. Furthermore, SCI patients show a significantly higher proportion of the more aggressive squamous cell carcinoma than that of the general population in areas not endemic for the tropical disease schistosomiasis. Consequently, the survival time is extremely unfavourable. A very important finding, for practical reasons is that, in the Hamburg study as well as in the literature, urinary bladder cancer is more frequently observed after 10 years or more of SCI. Based on these findings, a matrix was compiled where the various influencing factors, either for or against the recognition of an association between SCI and urinary bladder cancer, were weighted according to their relevance. CONCLUSIONS: The results showed that urinary bladder cancer in SCI patients differs considerably from that in able-bodied patients. The presented algorithm is an important aid in everyday clinical practice for assessing the correlation between SCI and bladder cancer.

Can clinical and urodynamic parameters predict the occurrence of neutralizing antibodies in therapy failure of intradetrusor onabotulinumtoxin A injections in patients with spinal cord injury?

BACKGROUND: The aim of the study was to clarify whether clinical and/or urodynamic parameters could be used to infer the probability of neutralizing antibody (NAb) formation as a possible cause of therapy failure (non-response, NR) in patients with neurogenic detrusor overactivity (NDO) due to acquired spinal cord injury/disease (SCI/D) treated with intradetrusor botulinum neurotoxin A (BoNT-A) injections. METHODS: A retrospective chart review was performed of all patients with SCI/D who underwent both intradetrusor onabotulinumtoxin A injections and the determination of neutralizing antibodies against BoNT-A between January 1, 2002, and December 31, 2018. NR was defined as urodynamically confirmed persistent or reappearing NDO. RESULTS: A total of 2700 BoNT-A injections in 414 patients were ascertained. In 69 patients with primary NR after the first BoNT-A injection (n = 6) or with secondary NR after more than one BoNT-A injection (n = 63), an antibody analysis was performed. Antibody examination showed 36 (52.2%) negative, 5 (7.2%) borderline and 14 (each 20.3%) each of positive and highly positive values. Subgroup analysis indicated a correlation between NAb formation and the duration of BoNT-A therapy (p = 0.015), the mean number of BoNT-A injections (p = 0.011) and the time interval between BoNT-A applications (< 7 months, p = 0.022). Urodynamic data analysis indicate significant differences with cut-off values of MCC (< 225 ml, p = 0.038) and MDP (> 45 cmH2O, p = 0.040). However, in the regression analysis models, the predictive value for the occurrence of NAb was too low (MCC: ROC AUC 0.62, MDP: ROC AUC 0.52) to distinguish with sufficient certainty between NAb-positive and NAb-negative NR patients. CONCLUSIONS: Despite significant correlations, clinical and urodynamic parameters are only partially suitable for predicting antibody formation against BoNT-A.

Incidental bladder cancer at initial urological workup of spinal cord injury patients.

STUDY DESIGN: Retrospective descriptive study. OBJECTIVES: To compare histopathological findings and the long-term course of SCI patients with bladder cancer found incidentally at the initial urological workup to those diagnosed with bladder cancer many years after the onset of SCI. SETTING: Spinal cord injury center in Germany. METHODS: Data and follow-up of consecutive in- and out-patients with SCI admitted at a tertiary spinal cord injury center between January 1, 1998 and December 31, 2018 were screened retrospectively. All patients with acquired SCI were evaluated for pathological findings in the urinary bladder present at the time of SCI on the initial urological workup. Data of 37 long-term SCI patients from the same center with diagnosed bladder cancer and data of the general German population served as reference groups. Descriptive statistics were applied. RESULTS: In total, four patients with bladder cancer at initial urological workup were assessed. They all had non-muscle invasive bladder cancer. Two of the patients were cystectomized 34 and 106 months after first bladder cancer diagnosis, due to relapsing tumor and progressive renal failure, respectively. In both cases no tumor was found in the resected bladder. All four patients are currently alive with no tumor and a mean follow-up of 105 months. CONCLUSIONS: In incidental bladder cancer observed at the initial urological workup after acquired SCI, the duration of SCI, at least in the first 5 years, does not noticeably contribute to a poor prognosis, i.e., progression to muscle invasive bladder cancer (≥T2) or a higher grading (G3).

The Real Daily Need for Incontinence Aids and Appliances in Patients with Neurogenic Bladder Dysfunction in a Community Setting in Germany.

PURPOSE: For successful long-term rehabilitation of patients with neurogenic lower urinary tract dysfunction (NLUTD), it is necessary to define the objective requirement for urological aids based on a scientifically validated basis. METHODS: This was a cross-sectional multicenter study, based on a questionnaire. Data concerning bladder management and daily consumption of urological appliances for patients with NLUTD in a community setting were collected through a standardized survey. RESULTS: Seven hundred and sixty-seven records were analyzed: 543 males, 221 females (N/A = 3). Patients using intermittent catheterization (n= 608) required 5.06 (mean) single-use catheters per day. Out of them, 94 (15.5%) required additional pads (mean: 2.29 per day), 34 patients (5.6%) additionally used pants (mean: 2.55 per day) and 46 patients (7.6%) utilized condom catheters (mean: 3.81 per day) between catheterizations. Among all, 126 patients (16.4%) used pads (mean: 5.03 per day), and 51 patients (6.6%) used pants (mean: 3.03 per day). Women needed both pads (p < 0.0001) and diapers (p = 0.0084) significantly more frequently than men. Eighty-two of the male patients (15.1%) applied condom catheters (mean: 2.8 per day). The target value of the objective daily requirement of incontinence aids for adult patients with NLUTD (based on the upper twofold standard deviation from the mean value) was defined as follows: up to nine single-use catheters, seven condom catheters, nine pads and/or seven pants. A "mixed supply" of different incontinence aids is part of the daily supply for many patients. CONCLUSION: For the first time, these results allow a reasonable regulation of urological aids and appliances based on scientific data for patients with neurogenic bladder.

Traumatic spinal cord injury confers bladder cancer risk to patients managed without permanent urinary catheterization: lessons from a comparison of clinical data with the national database.

PURPOSE: Life expectancy for people with traumatic spinal cord injury (SCI) is increasing due to advances in treatment methods and in neuro-urology. Thus, developing urinary bladder cancer (UBC) is gaining importance. METHODS: Single-centre retrospective evaluation of consecutive in- and out-patient data with spinal cord injury between January 1st, 1998 and December 31st, 2018 was carried out and data were compared with UBC data of the German population from the German Centre for Cancer Registry Data at Robert Koch Institute. RESULTS: A total of 37 (4 female, 33 male) out of 7004 patients with SCI were diagnosed with histologically proven UBC (median follow-up 85 months). Median age at UBC diagnosis was 54.0 years (general population: 74 years). The SCI patients had significantly (p < 0.0001, each) more frequent muscle-invasive tumors (81% ≥ T2) and unfavorable grading (76% G3), compared to the general population. Median survival was 13 months for transitional cell carcinoma (n = 31) and 4 months for squamous cell carcinoma (n = 5) (p = 0.0039), resp. The median survival of the 24 cystectomized patients was 15.0 months. Long-term suprapubic or indwelling catheterization was found in only eight patients for a total of only 5.09% (median 15.5 months) of the latency of all patients. No significant differences for T category and grading were observed between the bladder emptying methods intermittent catheterisation and catheter-free voiding. CONCLUSION: The results indicate that in patients with SCI bladder management even without permanent catheterization represents a considerable risk for the development of UBC.

Temporal Trends and Treatment Outcomes of Flexible Ureteroscopy for Lower Pole Stones in a Tertiary Referral Stone Center.

INTRODUCTION: To evaluate trends in efficacy and safety of flexible ureteroscopy (fURS) for the treatment of lower pole stones (LPS) over a 6-year period and to compare the annual outcomes after one fURS procedure retrospectively. PATIENTS AND METHODS: Four hundred nine patients were treated for pure LPS. An analysis of the annual outcomes regarding patient characteristics, operative parameters, stone-free rates (SFRs), and complication rates (CRs) was performed. The SFR was stratified according to stone size and number of stones per patient. Patient data are expressed as mean±standard deviation. RESULTS: There were no annual differences regarding age, body-mass index, stone size (7.09±4.31 mm), number of stones per patient (1.66±2.86), operative time (52.93±33.58 minutes), use of postoperative stents (59.2%), and the Ho:YAG laser lithotripsy rate (49.4%) during the 6-year period. Total primary SFR (annual range) of 97.6% (88.2%-100%), 89.1% (82.9%-96.3%), 71% (60%-78.6%) for urinary calculi <5 mm (3.43±0.78 mm), 5-9 mm (6.69±1.34 mm), and ≥10 mm (13.09±6.02 mm) could be demonstrated over the 6-year period. The total SFR differed significantly between urinary calculi <5 mm, 5-9 mm, and those ≥10 mm (p<0.0179). The SFR (annual range) decreased from 90% (86.2%-95.4%) in patients with 1 stone to 84.1% (60%-100%) in those with ≥3 stones. Perioperative complications (annual range) occurred in 9.7% (6%-13.6%) of the patients (Clavien I 5.1% [1.2%-8.6%], Clavien II 2% [0%-4.9%], Clavien IIIa 0.9% [0%-3.4%], Clavien IIIb 1.7% [1.2%-4.8%]) without differences in the annual CR. CONCLUSIONS: fURS is a safe and efficacious procedure for the treatment of LPS with high primary SFR and low CR. fURS in larger LPS (≥10 mm) is associated with the risk for staged procedures.

A prospective, randomized comparison of a 1940 nm and a 2013 nm thulium: yttrium-aluminum-garnet laser device for Thulium VapoEnucleation of the prostate (ThuVEP): First results.

INTRODUCTION: We report the early postoperative results of the first prospective, randomized comparison of two commercially available thulium lasers with different wavelengths for the treatment of benign prostatic obstruction (BPO). MATERIALS AND METHODS: From January to June 2013, 80 consecutive patients were randomized for Thulium VapoEnucleation of the prostate (ThuVEP) with a 2013 nm (RevoLix(®)) (n = 39) or a 1940 nm (Vela(®)XL) (n = 41) thulium laser. Preoperative status, surgical details and the immediate outcome were recorded for each patient. The perioperative complications were assessed and classified according to the modified Clavien classification system. RESULTS: Median operation time, resected tissue, percentage of resected tissue, catheter time, overall operation efficiency and Hb loss differed nonsignificantly between both devices (P > 0.05). At discharge, the median maximum urinary flow rate and postvoiding residual (PVR) urine improved significantly in both groups (P < 0.001). The PVR was lower in the 1940 nm ThuVEP group (P ≤ 0.034). Perioperative complications occurred in 18 (22.5%) patients (Clavien 1: 12.5%; Clavien 2: 5%, Clavien 3b: 2.5%, Clavien 4a: 2.5%), with no differences between the groups (P = 0.5). CONCLUSIONS: The 1940 nm and the 2013 nm thulium lasers are both safe and effective for the treatment of BPO with ThuVEP. Both lasers give equivalent and satisfactory immediate micturition improvement with low perioperative morbidity.

Is Prolonged Operation Time a Predictor for the Occurrence of Complications in Ureteroscopy?

OBJECTIVE: To determine the impact of duration of ureteroscopy for urolithiasis on complication rates (CRs) of the procedure. METHODS: A retrospective analysis of 2,010 patients, treated between 2006 and 2011, was done. The operation time (OT) and the occurrence of complications were compared. RESULTS: The overall CR was 14.3% [298 complications, minor complications (Clavien I-II) 91.7%]. The median OT was 35 min [interquartile range (IQR) 20-61]. The OT differed significantly between those without complications [34 min (IQR 20-60)] and those with complications [45 min (IQR 25-76)] (p < 0.0001). The correlation between the OT and the occurrence of complications (r = -0.009648, p < 0.0001) was very weak and passed the level of significance (r = 0.2). The effect size was of minor relevance (Cohen's d = 0.27972). CONCLUSIONS: Longer OT correlates significantly with a higher CR. The effect is however shown to be minor and the overall rate of complications, especially severe ones, is low.

Impact of surgical experience on stone-free rates of ureteroscopy for single urinary calculi of the upper urinary tract: a matched-paired analysis of 600 patients.

INTRODUCTION: To evaluate the impact of surgical experience on ureteroscopic stone-free rates (SFR) and complication rates (CR) for the treatment of urinary calculi of the upper urinary tract. METHODS: We evaluated retrospectively, patients (n=300) having undergone ureteroscopy (URS) for single urinary calculi treated by residents (n=12) at our department over a 6-year period. These patients were matched according to age, gender, body-mass index, and stone side/size/site with patients (n=300) treated by consultants (n=5) of our department during the same period. Patient data, primary SFR, and CR were compared. RESULTS: The mean±standard deviation (range) stone size was 6.39±3.26 (2-20) mm. The primary SFR after one URS procedure was 95.2% and did not differ between residents and consultants (95% vs 95.3%, p=0.489). The SFR were 95.9% and 98.5% for ureteral stones (p=0.125) and 93.2% and 89.3% for kidney stones (p=0.298) in the resident and consultant group, respectively. The SFR differed significantly between ureteral and kidney stones (97.2% vs 91.3%, p≤0.001). Perioperative complications occurred in a total of 63 patients (10.5%): Clavien 1: 3.8%, Clavien 2: 2%, Clavien 3a: 1.8%, and Clavien 3b: 2.8%, respectively. There were no differences in the total CR between residents (12%) and consultants (9%) (p=0.2116). However, the ureteral perforation rate was significantly higher in residents compared with consultants (4.3% vs 1.3%, p≤0.027). CONCLUSIONS: URS is a safe and efficacious procedure for the treatment of single urinary calculi. Resident status does not compromise the SFR after ureteroscopic treatment of single urinary calculi. However, the incidence of ureteral perforation was associated with surgeon's experience.

Association of prostate size and perioperative morbidity in thulium:YAG vapoenucleation of the prostate.

OBJECTIVE: To evaluate the association between perioperative morbidity and prostate size in patients with benign prostatic obstruction treated with thulium:YAG vapoenucleation of the prostate (ThuVEP). METHODS: 687 patients were prospectively analyzed. Prostate size was <40 ml in 196 (group A), 40-79 ml in 336 (group B) and ≥80 ml in 155 (group C) patients. RESULTS: The mean prostate sizes were 27.94 ± 6.77, 54.38 ± 10.54 and 109.8 ± 28.31 ml for groups A, B and C, respectively (p < 0.001). Hemoglobin loss (g/dl) differed significantly among group A (1.09 ± 1.02), group B (1.28 ± 1.27) and group C (1.62 ± 1.49) (p < 0.001). The correlation between hemoglobin loss and prostate size was very weak in all patients (r = 0.13, p ≤ 0.001). Peak urinary flow rates and post-voiding residual urine improved significantly (p < 0.001) without differences among the groups. The incidence of complications was low and not different among the groups (acute urinary retention 8%, urinary tract infection 4.66%, secondary apical resection 2.91%, transfusion rate 2.03%). CONCLUSIONS: Perioperative morbidity and micturition improvement are not associated with prostate size in ThuVEP.

Impact of thulium VapoEnucleation of the prostate on erectile function: a prospective analysis of 72 patients at 12-month follow-up.

OBJECTIVE: To evaluate changes in erectile function after thulium VapoEnucleation of the prostate (ThuVEP) for the treatment of benign prostatic obstruction at 12-month follow-up. MATERIALS AND METHODS: We prospectively evaluated 72 patients who underwent ThuVEP between January and July 2011. Preoperative evaluation included maximum urinary flow rate (Qmax), international prostate symptom score (IPSS), quality of life (QoL), postvoiding residual urine (PVR), and the Erectile function domain of the International Index of Erectile Function (IIEF-EF). According to preoperative IIEF-EF score, patients were classified into subgroup A (IIEF-EF ≥19, n = 38) and subgroup B (IIEF-EF <19, n = 34). All complications during the perioperative period were noted and classified according to the modified Clavien classification system. All patients were reassessed at 12-month follow-up by Qmax, IPSS, QoL, PVR, and IIEF-EF score. Patient data were expressed as median (interquartile range). RESULTS: Median patient age was 70 (65-73) years, and the median prostate volume was 52.5 (39.75-72) mL, respectively. At 12-month follow-up, IPSS (20 vs 4), QoL (4 vs 1), Qmax (9.7 vs 22.15 mL/s), and PVR (100 vs 15 mL) improved significantly in comparison with preoperative assessment (P ≤.001) without differences between subgroup A and B. A slight but not statistically significant increase of the IIEF-EF domain score was reported at 12-month follow-up (19.5 vs 20), which could be shown in subgroup A (25 vs 26) and B (6 vs 8). CONCLUSION: ThuVEP is a safe and effective procedure for the treatment of benign prostatic obstruction. At 12-month follow-up, marginal nonsignificant erectile function improvement was reported after surgery.

Systematic evaluation of a holmium:yttrium-aluminum-garnet laser lithotripsy device with variable pulse peak power and pulse duration.

OBJECTIVE: The Holmium:yttrium-aluminum-garnet (Ho:YAG) laser is the standard lithotrite for ureteroscopy. This paper is to evaluate a Ho:YAG laser with a novel effect function in vitro, which allows a real-time variation of pulse duration and pulse peak power. METHODS: Two types of phantom calculi with four degrees of hardness were made for fragmentation and retropulsion experiments. Fragmentation was analysed at 5 (0.5 J/10 Hz), 10 (1 J/10 Hz), and 20 (2 J/10 Hz) W in non-floating phantom calculi, retropulsion in an ureteral model at 10 (1 J/10 Hz) and 20 (2 J/10 Hz) W using floating phantom calculi. The effect function was set to 25%, 50%, 75%, and 100% of the maximum possible effect function at each power setting. Primary outcomes: fragmentation (mm3), the distance of retropulsion (cm); ≥5 measurements for each trial. RESULTS: An increase of the effect feature (25% vs. 100%), i.e., an increase of pulse peak power and decrease of pulse duration, improved Ho:YAG laser fragmentation. This effect was remarkable in soft stone composition, while there was a trend for improved fragmentation with an increase of the effect feature in hard stone composition. Retropulsion increased with increasing effect function, independently of stone composition. The major limitations of the study are the use of artificial stones and the in vitro setup. CONCLUSION: Changes in pulse duration and pulse peak power may lead to improved stone fragmentation, most prominently in soft stones, but also lead to increased retropulsion. This new effect function may enhance Ho:YAG laser fragmentation when maximum power output is limited or retropulsion is excluded.