Urodynamics Are Essential to Predict the Risk for Upper Urinary Tract Damage after Acute Spinal Cord Injury.

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.

Transurethral injection of autologous muscle precursor cells for treatment of female stress urinary incontinence: a prospective phase I clinical trial.

INTRODUCTION AND HYPOTHESIS: The purpose was to investigate the safety and feasibility of transurethral injections of autologous muscle precursor cells (MPCs) into the external urinary sphincter (EUS) to treat stress urinary incontinence (SUI) in female patients. METHODS: Prospective and randomised phase I clinical trial. Standardised 1-h pad test, International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF), urodynamic study, and MRI of the pelvis were performed at baseline and 6 months after treatment. MPCs gained through open muscle biopsy were transported to a GMP facility for processing and cell expansion. The final product was injected into the EUS via a transurethral ultrasound-guided route. Primary outcomes were defined as any adverse events (AEs) during follow-up. Secondary outcomes were functional, questionnaire, and radiological results. RESULTS: Ten female patients with SUI grades I-II were included in the study and 9 received treatment. Out of 8 AEs, 3 (37.5%) were potentially related to treatment and treated conservatively: 1 urinary tract infection healed with antibiotics treatment, 1 dysuria and 1 discomfort at biopsy site. Functional urethral length under stress was 25 mm at baseline compared with 30 mm at 6 months' follow-up (p=0.009). ICIQ-UI-SF scores improved from 7 points at baseline to 4 points at follow-up (p=0.035). MRI of the pelvis revealed no evidence of tumour or necrosis, whereas the diameter of the EUS muscle increased from 1.8 mm at baseline to 1.9 mm at follow-up (p=0.009). CONCLUSION: Transurethral injections of autologous MPCs into the EUS for treatment of SUI in female patients can be regarded as safe and feasible. Only a minimal number of expected and easily treatable AEs were documented.

Temporal development of unfavourable urodynamic parameters during the first year after spinal cord injury.

OBJECTIVES: To describe the temporal development of and risk factors for the occurrence of unfavourable urodynamic parameters during the first year after spinal cord injury (SCI). PATIENTS AND METHODS: This population-based longitudinal study used data from 97 adult patients with a single-event traumatic or ischaemic SCI who underwent video-urodynamic investigation (UDI) at a university SCI centre. The first occurrences of unfavourable urodynamic parameters (detrusor overactivity combined with detrusor sphincter dyssynergia [DO-DSD], maximum storage detrusor pressure ≥40 cmH2 O, bladder compliance <20 mL/cmH2 O, vesico-ureteric reflux [VUR] and any unfavourable parameter [composite outcome]) were evaluated using time-to-event analysis. RESULTS: The majority of the population (87/97 [90%]) had at least one unfavourable urodynamic parameter. Most unfavourable urodynamic parameters were initially identified during the 1- or 3-month UDI, including 92% of the DO-DSD (78/85), 82% of the maximum storage pressure ≥40 cmH2 O (31/38), and 100% of the VUR (seven of seven) observations. No low bladder compliance was observed. The risk of DO-DSD was elevated in patients with thoracic SCI compared to those with lumbar SCI (adjusted hazard ratio [aHR] 2.38, 95% confidence interval [CI] 1.16-4.89). Risk of maximum storage detrusor pressure ≥40 cmH2 O was higher in males than females (aHR 8.33, 95% CI 2.51-27.66), in patients with a cervical SCI compared to those with lumbar SCI (aHR 14.89, 95% CI 3.28-67.55), and in patients with AIS Grade B or C compared to AIS Grade D SCI (aHR 6.17, 95% CI 1.78-21.39). No risk factors were identified for the composite outcome of any unfavourable urodynamic parameter. CONCLUSIONS: The first UDI should take place within 3 months after SCI as to facilitate early diagnosis of unfavourable urodynamic parameters and timely treatment. Neuro-urological guidelines and individualised management strategies for patients with SCI may be strengthened by considering sex and SCI characteristics in the scheduling of UDIs.

Neurogenic Lower Urinary Tract Dysfunction in the First Year After Spinal Cord Injury: A Descriptive Study of Urodynamic Findings.

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 parameters that are associated with urological morbidity. MATERIALS AND METHODS: Urodynamic investigations from 97 patients with traumatic or ischemic acute spinal cord injury and managed according to the European Association of Urology Guidelines on Neuro-Urology were analyzed at a single university spinal cord injury center at 1 month, 3 months, 6 months, and 12 months after injury. Unfavorable urodynamic parameters were defined as detrusor overactivity in combination with detrusor sphincter dyssynergia, maximum storage detrusor pressure of 40 cm H2O or higher, bladder compliance less than 20 mL/cm H2O, and vesicoureteral reflux of any grade. RESULTS: One or more unfavorable urodynamic parameter was observed in 87 out of 97 patients (90%) within the first year after spinal cord injury. Eighty-eight percent of the patients showed detrusor overactivity with detrusor sphincter dyssynergia, 39% a maximum storage detrusor pressure of 40 cm H2O or higher, and 7% vesicoureteral reflux. No patient developed a low-compliance bladder. CONCLUSIONS: Using a standardized urodynamic follow-up schedule, we found unfavorable urodynamic parameters in a majority of the population within the first year after spinal cord injury. As early treatment based on urodynamic findings might reduce the risk of deterioration of upper and lower urinary tract function, thereby improving long-term outcomes, there is need for further research regarding recommendations for a urodynamic follow-up schedule during the first year after spinal cord injury.

Photoselective vaporization of the prostate: study outcomes as a function of risk of bias, conflicts of interest, and industrial sponsorship.

PURPOSE: To investigate the outcomes of comparative studies on photoselective vaporization of the prostate (PVP) as a function of risk of bias (RoB), conflicts of interest (COI), and industrial sponsorship (IS). METHODS: We performed a systematic literature search for comparative studies on PVP [randomized controlled trials (RCTs) and non-randomized comparative studies (NRCSs)]. Study selection as well as comprehensive assessment of RoB, COIs, and IS were performed in duplicate. The identified studies were further rated by two independent board-certified urologists as either PVP-favourable or PVP-unfavourable. Descriptive statistics were performed among all identified studies and among the subgroups of studies rated as favourable and unfavourable, respectively. RESULTS: Sixty-five studies qualified for inclusion (25 RTCs and 40 NRCSs) of which 56 (86%) were rated favourable and 9 (14%) unfavourable. A majority of all studies mentioned the absence/presence of potential COIs (78%). In contrast, a sponsorship statement was only found in 29% of the investigations. Studies rated favourable demonstrated a higher percentage of COIs (39% versus 22%). IS was exclusively found among favourable studies. Furthermore, a serious or critical RoB was more often found in favourably rated NRCSs. CONCLUSIONS: COIs and IS seem to be associated with favourable study outcomes in comparative studies on PVP. The transparency of the whole research process from study conception to the dissemination of the results has to be further improved to prevent a harmful effect of COIs and IS on the internal validity of studies.

Detrusor overactivity is missed by stopping urodynamic investigation at a bladder volume of 500 mL.

OBJECTIVES: To investigate whether detrusor overactivity (DO) is missed in a relevant percentage of patients if the urodynamic investigation (UDI) is stopped at a filling volume of 500 mL due to the fear of bladder overdistention, in patients with lower urinary tract symptoms and high bladder capacity. PATIENTS AND METHODS: A consecutive series of 1598 patients with a bladder capacity of >500 mL in the bladder diary undergoing UDI due to lower urinary tract dysfunction (LUTD) was prospectively investigated. UDI was performed according to Good Urodynamic Practices recommended by the International Continence Society. UDI was stopped at strong desire to void or in case of autonomic dysreflexia, vesico-uretero-renal reflux, bladder pain or discomfort. RESULTS: Of the 1598 patients (594 women, 1004 men), 1282 (80%) and 316 (20%) had neurogenic and non-neurogenic LUTD, respectively. Overall, DO was detected in 66% (1048/1598), in 71% (910/1282) with neurogenic and in 44% (138/316) with non-neurogenic LUTD. DO occurred in 16% (263/1598, 95% confidence interval [CI] 14.7-18.4%) only at a bladder volume >500 mL. This phenomenon was significantly (P < 0.001) more frequent in patients with neurogenic (18% [236/1282], 95% CI 16.4-20.6%) compared with non-neurogenic (9% [27/316], 95% CI 5.9-12.1%) LUTD. CONCLUSIONS: In both neurological and non-neurological patients with high bladder capacity, we strongly recommend not to stop UDI at a bladder volume of 500 mL, as DO might be missed in a relevant percentage leading to inappropriate patient treatment.

Pure Bipolar Plasma Vaporization of the Prostate: Results from a Prospective 3D Ultrasound Volumetry Study with Clinical Outcome After 3 Years.

INTRODUCTION AND OBJECTIVES: Bipolar plasma vaporization (BPV) has been shown to be a low-morbidity alternative to conventional transurethral resection of the prostate (TURP). Improved functional short-term outcome and a postoperative prostate volume reduction comparable to TURP have been reported. However, comprehensive mid- or long-term results following BPV are still lacking. METHODS: A consecutive series of men who underwent pure BPV in a tertiary care academic center was prospectively investigated. Clinical parameters [International Prostate Symptom Score with Quality-of-Life domain, peak urinary flow rate (Qmax), postvoid residual volume, and prostate-specific antigen] as well as prostate volume (assessed by planimetric volumetry following transrectal 3D-ultrasound) were recorded preoperatively and regularly after BPV (after catheter removal, 6 weeks, 6 months, 1 year, and 3 years). Statistical analysis was performed using the Wilcoxon signed-rank test. All p-values ≤0.05 were considered significant. RESULTS: Seventy-five men were included in this prospective investigation. Their median (interquartile range) prostate volume was 41.0 mL (30.6-57.4 mL). In the first year after BPV, the prostate volume continuously decreased over time and the relative volume reduction was 52.2% after 12 months. Subsequently, the volume reduction remained stable with 50.7% after 3 years. All investigated outcome parameters improved significantly after the procedure and remained so after 3 years. Reoperations due to persistent or regrown adenoma were not necessary. Six (8.0%) and five patients (6.6%) developed a de novo urethral stricture or bladder neck contracture, respectively. CONCLUSIONS: Three years after pure BPV of the prostate, a durable prostate volume reduction in combination with a stable improvement of functional outcome parameters was detectable in our prospective study. The low morbidity of the procedure and the possibility to perform BPV under ongoing platelet aggregation inhibition confirms its role as minimally invasive alternative to conventional TURP.

Is Detrusor Contraction during Rapid Bladder Filling Caused by Cold or Warm Water? A Randomized, Controlled, Double-Blind Trial.

PURPOSE: We investigated whether detrusor contraction during rapid bladder filling is provoked by cold or warm water. MATERIALS AND METHODS: Patients with neurogenic lower urinary tract dysfunction were included in this randomized, controlled, double-blind trial. At the end of a standard urodynamic investigation patients underwent 2 bladder fillings using a 4C ice water test or a 36C warm water test saline solution at a filling speed of 100 ml per minute. The order was randomly selected, and patients and investigators were blinded to the order. The primary outcome measure was detrusor overactivity, maximum detrusor pressure and maximum bladder filling volume during the ice and warm water tests. RESULTS: Nine women and 31 men were the subject of data analysis. Neurogenic lower urinary tract dysfunction was caused by spinal cord injury in 33 patients and by another neurological disorder in 7. Irrespective of test order detrusor overactivity occurred significantly more often during the ice water test than during the warm water test (30 of 40 patients or 75% vs 25 of 40 or 63%, p = 0.02). When comparing the ice water test to the warm water test, maximum detrusor pressure was significantly higher and maximum bladder filling volume was significantly lower during the ice water test (each p <0.001). The order of performing the tests (ice water first vs warm water first) had no effect on the parameters. CONCLUSIONS: Our findings imply that the more frequent detrusor overactivity, higher maximum detrusor pressure and lower bladder filling volume during the ice water test compared to the warm water test were caused by cold water. This underlies the theory of a C-fiber mediated bladder cooling reflex in humans.

Effects of onabotulinumtoxinA on cardiac function following intradetrusor injections.

OnabotulinumtoxinA intradetrusor injections are considered a highly effective localized therapy for refractory detrusor overactivity. However, despite evidence for distant systemic effects of onabotulinumtoxinA, little is known on potential systemic side effects following intradetrusor injections. Given that onabotulinumtoxinA is a highly potent toxin this is an important safety issue specifically with regard to repeat injections and parallel treatments with botulinum toxin. Hence, it was the purpose of this prospective study to investigate, using heart rate variability (HRV) analysis, whether onabotulinumtoxinA causes systemic effects on cardiac function following intradetrusor injections. Patients with neurogenic detrusor overactivity (NDO) and age-matched healthy controls were recruited. Concomitant medication and diseases affecting the cardio-vascular system were exclusion criteria. A 3-channel resting electrocardiogram (ECG) was recorded in supine position for 15min during four consecutive visits: 1) 2weeks prior onabotulinumtoxinA intradetrusor injections, 2) 10min prior injections, 3) 30min after injections, and 4) 6weeks after injections. NDO patients received intradetrusor injections (300units Botox®) between visits 2 and 3. The control group had no intervention. Short-term (5min) HRV analysis included assessment of frequency and time domain parameters. Statistical analysis was performed using ANOVA with repeated measures and the t-test. Due to multiple comparisons, α was corrected to 0.0125 (Bonferroni method). Twelve healthy volunteers (5♀, 7♂; 46±12years old) and 12 NDO patients (5♀, 7♂; 46±13years old) completed all measurements. Comparing both groups, resting heart rate was significantly higher in the patients group at visit 4 only. No further significant differences in time and frequency domain parameters were discovered. Within the NDO group, standard deviation of the normal to normal intervals (SDNN) in the ECG demonstrated a significant decrease (1.70 to 1.53ms, p=0.003) from visit 3 to 4, whereas the total power (TP) significantly increased (3.05 to 3.29ms2, p=0.009) from visit 2 to 3. This increase subsided until visit 4. STUDY LIMITATIONS: single treatment investigation under resting conditions only. In conclusion, onabotulinumtoxinA intradetrusor injections do not seem to affect resting state cardiac function. Short-term changes such as total power might rather result from natural cardio-vascular responses to the procedure itself (e.g. discomfort, stress). Further detailed investigations also under physical stress and repeated injections are necessary to fully exclude systemic cardiac side effects of onabotulinumtoxinA intradetrusor injections.

Absorption of irrigation fluid during XPS™ GreenLight laser vaporization of the prostate: results from a prospective breath ethanol monitoring study.

PURPOSE: To assess whether and to what extent irrigation fluid absorption occurs during laser vaporization (LV) of the prostate using the 180 W XPS™ GreenLight laser. METHODS: This prospective investigation was performed in a tertiary care center with a consecutive series of patients undergoing 180 W LV of the prostate. Intraoperative irrigation was performed with isotonic saline containing 1 % ethanol. The volume of irrigation fluid absorption was calculated from periodically performed breath ethanol measurements during LV. Additionally, intraoperative changes in biochemical and hematological blood parameters were assessed. RESULTS: Positive breath ethanol tests were detectable in 22 of 54 patients. The median absorption volume in these patients was 950 ml (range 208-4579 ml). Ten patients absorbed more than 2000 ml. Absorbers had smaller prostates, more capsular perforations and injuries to venous sinuses, and more total energy was applied with higher output power. Five patients had transient symptoms potentially related to fluid absorption. A significant drop in hemoglobin, hematocrit, venous pH and bicarbonate and an increase in chloride were detectable in the absorber group. These changes were significantly different in the non-absorber group. CONCLUSIONS: Absorption of irrigation fluid did occur in a relevant proportion of patients undergoing XPS™ GreenLight LV. High-volume absorption (≥2000 ml), which might be clinically relevant, was detectable in almost 20 % of all procedures. Absorption of saline irrigation fluid does not result in a classical TUR syndrome, but fluid and chloride overload can lead to serious complications, particularly in cardiovascular high-risk patients. Thus, patients with symptoms potentially related to fluid absorption should be monitored carefully.

Acute spinal cord injury--do ambulatory patients need urodynamic investigations?

PURPOSE: We compared the urodynamic parameters of ambulatory vs nonambulatory acute spinal cord injured patients. MATERIALS AND METHODS: A total of 27 women and 33 men (mean age 58 years) with neurogenic lower urinary tract dysfunction due to acute spinal cord injury (duration of injury less than 40 days) were prospectively evaluated. The patients were dichotomized according to the mobility for moderate distances subscale of the SCIM (Spinal Cord Independence Measure) version III into ambulatory (score of 3 or greater) and nonambulatory (score less than 3). Videourodynamic parameters including maximum detrusor pressure during the storage phase, bladder compliance, detrusor overactivity, detrusor external sphincter dyssynergia and vesicoureterorenal reflux were compared between the groups. RESULTS: Of the 60 patients with acute spinal cord injury 17 were ambulatory and 43 were nonambulatory. Mean ± SD duration of injury at urodynamic investigation was 30 ± 8 days. The lesion level was cervical in 14 patients, thoracic in 28 and lumbar/sacral in 18. Comparing unfavorable urodynamic parameters, no significant differences were found between ambulatory vs nonambulatory patients in terms of a high pressure system during the storage phase (29% vs 33%, p = 0.81), a low compliance bladder (12% vs 7%, p = 0.54), detrusor overactivity (24% vs 47%, p = 0.1), detrusor external sphincter dyssynergia (18% vs 21%, p = 0.77) and vesicoureterorenal reflux (0% vs 5%, p = 0.36). CONCLUSIONS: Ambulatory and nonambulatory patients with acute spinal cord injury have a similar risk of unfavorable urodynamic measures. Thus, we strongly recommend the same neurourological assessment including urodynamic investigations in all acute spinal cord injury patients independent of the ability to walk.

External urethral sphincter pressure measurement: an accurate method for the diagnosis of detrusor external sphincter dyssynergia?

BACKGROUND: Combined pelvic floor electromyography (EMG) and videocystourethrography (VCUG) during urodynamic investigation are the most acceptable and widely agreed methods for diagnosing detrusor external sphincter dyssynergia (DESD). Theoretically, external urethral sphincter pressure (EUSP) measurement would provide enough information for the diagnosis of DESD and could simplify the urodynamic investigation replacing combined pelvic floor EMG and VCUG. Thus, we evaluated the diagnostic accuracy of EUSP measurement for DESD. PATIENTS #ENTITYSTARTX00026; METHODS: A consecutive series of 72 patients (36 women, 36 men) with neurogenic lower urinary tract dysfunction able to void spontaneously was prospectively evaluated at a single university spinal cord injury center. Diagnosis of DESD using EUSP measurement (index test) versus combined pelvic floor EMG and VCUG (reference standard) was assessed according to the recommendations of the Standards for Reporting of Diagnostic Accuracy Initiative. RESULTS: Using EUSP measurement (index test) and combined pelvic floor EMG and VCUR (reference standard), DESD was diagnosed in 10 (14%) and in 41 (57%) patients, respectively. More than half of the patients presented discordant diagnosis between the index test and the reference standard. Among 41 patients with DESD diagnosed by combined pelvic floor EMG and VCUR, EUSP measurement identified only 6 patients. EUSP measurement had a sensitivity of 15% (95% CI 5%-25%), specificity of 87% (95% CI 76%-98%), positive predictive value of 60% (95% CI 30%-90%), and negative predictive value of 56% (95% CI 44%-68%) for the diagnosis of DESD. CONCLUSIONS: For diagnosis of DESD, EUSP measurement is inaccurate and cannot replace combined pelvic floor EMG and VCUR.

Neurogenic lower urinary tract dysfunction--do we need same session repeat urodynamic investigations?

PURPOSE: We investigated whether same session repeat urodynamic investigations are needed in patients with neurogenic lower urinary tract dysfunction. MATERIALS AND METHODS: A consecutive series of 226 patients with neurogenic lower urinary tract dysfunction who underwent same session repeat urodynamic investigation was prospectively investigated at a single university spinal cord injury center. Urodynamics were done according to the good urodynamic practices recommended by the International Continence Society. All 226 patients underwent same session repeat consecutive filling cystometry and 88 also underwent pressure flow studies if they could void spontaneously. Repeatability of the 2 measurements was assessed using the Bland and Altman 95% limits of agreement, and the κ statistic. RESULTS: Mean age of the 226 patients enrolled was 52 years (range 18 to 90). Of the patients 94 (42%) were women and 132 were (58%) men. Detrusor overactivity repeatability was excellent between the 2 urodynamic investigations (κ=0.87, 95% CI 0.80-0.94). For all other urodynamic parameters assessed there were wide 95% limits of agreement for differences in the parameters, indicating poor repeatability. CONCLUSIONS: In same session repeat urodynamic investigations of patients with neurogenic lower urinary tract dysfunction detrusor overactivity demonstrates excellent repeatability but all other urodynamic parameters show insufficient agreement. Thus, we strongly recommend that clinical decision making not be based on a single urodynamic investigation since repeat measurements may yield completely different results.

In vivo identification of uric acid stones with dual-energy CT: diagnostic performance evaluation in patients.

BACKGROUND: To prospectively investigate the in vivo diagnostic performance of dual-energy (DE) computed tomography (CT) for the differentiation between uric acid (UA)-containing and non-UA-containing urinary stones. METHODS: DE CT scans were performed in 180 patients with suspected urinary stone disease using a dual-source CT scanner in the DE mode (tube voltages 80 and 140 kV). Urinary stones were classified as UA-containing or non-UA-containing based on CT number measurements and DE software results. Sensitivity, specificity, positive predictive values (PPV), and negative predictive values (NPV) for the detection of UA-containing urinary stones were calculated using the crystallographic stone analysis as the reference standard. RESULTS: DE CT detected 110/180 patients (61%) with urinary stone disease. In 53 patients, stones were sampled. Forty-four out of 53 stones (83%) were non-UA-containing; and nine stones (17%) were UA-containing. The software automatically mapped 52/53 (98%) stones. One non-UA-containing stone (UA, 2 mm) was missed; one UA-containing stone (3 mm) was misclassified by software analysis. The sensitivity, specificity, PPV, and NPV for the detection of UA-containing stones was 89% (8/9, 95% CI: 52-100%), 98% (43/44, 95% CI: 88-100%), 89% (8/9, 95% CI: 52-100%), and 98% (43/44, 95% CI: 88-100%). CONCLUSION: Our results indicate that DE dual-source CT permits for the accurate in vivo differentiation between UA-containing and non-UA-containing urinary stones.