Improved emptying performance with a new micro-hole zone catheter in adult male intermittent catheter users: A comparative multi-center randomized controlled cross-over study.

AIMS: To confirm the improved performance of the micro-hole zone catheter (MHZC) compared to a conventional eyelet catheter (CEC) in male users of clean intermittent catheterizations (CICs). METHODS: Male self-catheterizing subjects, who used hydrophilic sleeved soft/flexible CIC as the only bladder emptying method, were enrolled into a multi-center, randomized, cross-over study performed across six European sites. Subjects tested the MHZC, featuring a drainage zone with 120 micro-holes and a CEC with two eyelets. The study consisted of four study visits (V0-V3), during which endpoints related to catheter performance (urinary flow-stops, bladder emptying, and intra-catheter pressure) were measured and two 4-week test periods at home (T1 and T2) where dipstick hematuria and user perception between catheters were evaluated. RESULTS: Seventy-three male subjects with non-neurogenic and neurogenic bladder dysfunction (3:2) were enrolled. On average, catheterizations with the MHZC led to close to mean zero flow-stops compared to ≥1 flow-stops with the CEC, during both HCP- and self-led catheterizations (both p < 0.001). Residual urine at first flow-stop was significantly reduced for the MHZC compared to CEC (p = 0.001 and p = 0.004, for HCP- and self-led catheterizations, respectively). This was substantiated by a significantly smaller pressure peak at first flow-stop, a proxy for minimized mucosal suction (both HCP- and self-led catheterizations, p < 0.001). After home-use catheterizations, dipstick hematuria was comparable between catheters, whereas catheterizations were associated with significantly improved perception in favor of MHZC regarding bladder emptying, less blocking sensation, and improved hygienic catheterization compared to the CEC. CONCLUSION: This study confirmed the evidence of improved bladder emptying with the MHZC compared to a CEC without the need to reposition the catheter. The MHZC therefore offers an enhanced benefit for the dependent CIC user securing complete bladder emptying in an uninterrupted free flow and reducing the need to reposition the catheter during emptying.

Improved Performance With the Micro-Hole Zone Intermittent Catheter: A Combined Analysis of 3 Randomized Controlled Studies Comparing the New Catheter Technology With a Conventional Eyelet Catheter.

PURPOSE: To assess the performance of a new urinary intermittent catheter (IC) prototype designed with a micro-hole drainage zone compared to a conventional eyelet catheter (CEC) in terms of flow-stop, bladder emptying, and hematuria. DESIGN: Randomized controlled crossover studies. SUBJECT AND SETTING: The sample comprised 15 male healthy volunteers (HV) and 15 IC users, along with 15 female HV and 15 IC users. The age range was lower for HV participants than for IC users (range: 20-57 years for HV vs 21-82 years for IC users). The study setting was the Department of Urology, located in Rigshospitalet, Copenhagen. METHODS: Number of flow-stop incidents, residual urine volume at first flow-stop (RV1), and dipstick hematuria were measured during and after catheterization by a health care professional (HV) and by self-catheterisation (IC-users). Results from the 3 studies were combined for HV and IC users on RV1 and number of flow-stop incidents but separated on sex. For incidents of hematuria, an effect of underlying condition was assumed, and a combined analysis on sex was performed, separating HV and IC users. RESULTS: When compared to the micro-hole drainage zone design, catheterizations with CEC resulted in a significantly higher mean RV1 (mean difference: 49 mL in males and 32 mL in females, both P < .001) and average number of flow-stop incidents (8 and 21 times more frequent for males and females, respectively, both P < .001). The likelihood for hematuria was 5.84 higher with CEC than with micro-hole drainage hole design, P = .053, during normal micturition in HV postcatheterization. No serious adverse events were reported. CONCLUSION: The micro-hole drainage zone catheter provides IC users fewer premature flow-stops. This design feature reduces modifiable urinary tract infection risk factors, such as residual urine and micro-trauma; additional research is needed to determine its effects on bladder health.

Open vs robot-assisted radical cystectomy (BORARC): a double-blinded, randomised feasibility study.

OBJECTIVE: To examine surgical outcomes and feasibility of blinding patients and care providers to the surgical technique of radical cystectomy (RC). PATIENTS AND METHODS: Single-centre, parallel-group, double-blinded, randomised feasibility study of open RC (ORC) vs robot-assisted RC with intracorporeal urinary diversion (iRARC) in an 'Enhanced Recovery After Surgery' setup. A total of 50 patients aged ≥18 years with bladder cancer planned for RC with an ileal conduit were included. Patients with previous major abdominal/pelvic surgery, pelvic radiation or anaesthesiological contraindications were excluded. Primary outcomes were proportion of unblinded patients and success of blinding using Bang's Blinding Index. Secondary outcomes included length of stay (LOS), complication rates, blood loss, pain, and opioid consumption. RESULTS: A total of 26% of the patients were unblinded before discharge. We demonstrated that patients and doctors remained blinded for the allocated treatment, but nurses did not. Blood loss was greater in the ORC group as was operative time in the iRARC group. We found no difference in complication rate, LOS, or use of analgesics. CONCLUSIONS: The present study demonstrates that blinding of surgical technique in RC is possible. The results of secondary outcomes are consistent with the findings of previous unblinded randomised controlled trials. Our study highlights that it is possible to perform a blinded phase III study to explore the optimal surgical technique in RC.

Long term continuation with repeated Botulinum toxin A injections in people with neurogenic detrusor overactivity after spinal cord injury.

STUDY DESIGN: Retrospective chart study. OBJECTIVES: The aim was to examine continuation of treatment of individuals with spinal cord injury including myelomeningocele and neurogenic detrusor overactivity, treated with repeated intra-detrusor Botulinum toxin A injections, and to investigate factors associated with discontinuation of treatment. SETTING: Rigshospitalet, Denmark METHODS: This study included 128 individuals with spinal cord injury and neurogenic detrusor overactivity, who were offered repeated Botulinum toxin A injections between 2001 and 2018. Continuation rates of the treatment were estimated using Kaplan Meier analysis. A Cox proportional hazard analysis was used to investigate factors predictive of discontinuation. RESULTS: A total of 1156 treatments were performed. The median number of treatments was six (IQR 9, range 1-51), and median follow-up was 10.6 years (IQR 8.5, range 0-16.9). All urodynamic parameters changed significantly after the first treatment (p < 0.001). The continuation group had significantly higher mean maximum bladder capacity after the first injections compared with the discontinuation group, with a mean difference between the groups of 84.5 mL (95% CI 4.7-164.2) (p = 0.038). The probability of continuing treatments after 5 years was 59% (95% CI 50.0-67.8) and 50% (95% CI 40.1-59.3) after 10 years. Individuals aged 31-50 years were more likely to continue treatment compared with those aged >50 years (95% CI 0.21‒0.79) (p = 0.008). No other factors predicted discontinuation. CONCLUSIONS: This long-term follow-up study showed that 50% of people with spinal cord injury starting intra-detrusor Botulinum toxin A for neurogenic detrusor overactivity are still receiving injections after 10 years.

Feasibility and acceptability of couple counselling and pelvic floor muscle training after operation for prostate cancer.

BACKGROUND: Radical prostatectomy is often followed by long-lasting erectile dysfunction and urinary incontinence, with adverse effects on the quality of life and intimate relationship of patients and partners. We developed the ProCan intervention to ameliorate sexual and urological dysfunction after radical prostatectomy and examined its feasibility, acceptability and changes in sexual function. MATERIAL AND METHODS: Between May 2014 and October 2014, seven couples attending the Department of Urology, Rigshospitalet, were included 3-4 weeks after radical prostatectomy in the ProCan intervention, which consists of up to six couple counselling sessions, group instruction in pelvic floor muscle training (PFMT), up to three individual PFMT sessions and a DVD home training program. We examined its feasibility on the basis of the recruitment rate, adherence to and acceptability of the intervention, the response rate and changes in erectile and sexual functioning measured on the International Index of Erectile Function at baseline and at eight and 12 months. RESULTS: The recruitment rate was 14%. One couple withdrew, six couples attended 1-4 counselling sessions, and all patients attended PFMT until continence was achieved. The response rate on outcomes was 85% for patients and 71% for partners. The couples reported that counselling improved their sex life but it did not improve their ability to talk openly about sex. Most patients found that the physiotherapist improved their motivation and the quality and intensity of PFMT. Erectile dysfunction improved from severe at baseline to moderate at eight months' follow-up, and mean sexual functioning improved from 18.4 to 37.1 points at eight months' follow-up, but decreased slightly to 31.4 at 12 months. CONCLUSION: Our results suggest that the recruitment procedure should be adapted and minor revisions are needed in the intervention. The key components, couple counselling and PFMT, were well accepted and achievable for the patients.

Renal deterioration after spinal cord injury is associated with length of detrusor contractions during cystometry-A study with a median of 41 years follow-up.

AIMS: To investigate which urodynamic parameters are associated with renal deterioration over a median of 41 years follow-up after traumatic spinal cord injury. METHODS: Medical records of patients with a traumatic spinal cord injury sustained 1944-1975 were reviewed from time of injury until 2012. Patients who attended regular renography and/or renal clearance examinations and had minimum one cystometry and pressure-flow study were included. Renal deterioration was diagnosed as split renal function ≤30% in one kidney or relative glomerular filtration rate ≤51% of expected according to age and gender. Detrusor function, presence of detrusor sphincter dyssynergia, maximum detrusor pressure, post-void residual volume, and cystometric bladder capacity were obtained. In patients with detrusor overactivity, a detrusor overactivity/cystometry ratio was calculated using duration of detrusor contraction(s) during filling cystometry divided by total duration of filling cystometry. RESULTS: A total of 73 patients were included in the study, and the median follow-up time was 41 years after injury (range 24-56). Sixty-four patients (88%) used reflex triggering or bladder expression as bladder emptying method for the longest period after injury. During follow-up 60% changed to clean intermittent catheterization. The majority of the patients (68%) had neurogenic detrusor overactivity. In 35 patients, a detrusor-overactivity/cystometry ratio could be calculated and a detrusor overactivity/cystometry ratio > 0.33 was significantly associated with renal deterioration (P < 0.02). No significant association was found between maximum detrusor pressure or other urodynamic parameters and renal deterioration. CONCLUSIONS: Duration of detrusor overactivity longer than one third of the duration of cystometry is associated with renal deterioration after spinal cord injury.

Postoperative Urinary Catheterization Thresholds of 500 versus 800 ml after Fast-track Total Hip and Knee Arthroplasty: A Randomized, Open-label, Controlled Trial.

BACKGROUND: No evidence-based threshold exists for postoperative urinary bladder catheterization. The authors hypothesized that a catheterization threshold of 800 ml was superior to 500 ml in reducing postoperative urinary catheterization and urological complications after fast-track total hip arthroplasty (THA) and total knee arthroplasty (TKA). METHODS: This was a randomized, controlled, open-label trial that included patients greater than or equal to 18 yr who underwent THA or TKA in three Danish, fast-track, orthopedic departments. Consenting patients were eligible if they were cooperative and understood Danish. Participants were randomly allocated to a catheterization threshold of 500 or 800 ml, using opaque sealed envelopes. Group assignment was unmasked. Ultrasound bladder scans were performed every second hour until the first voluntary micturition, with subsequent urinary catheterization according to group assignment. The primary outcome was the number of patients catheterized before their first voluntary micturition. Thirty-day telephonic follow-up was on voiding difficulties, urinary tract infections, and readmissions. RESULTS: Of 800 patients allocated, 721 (90%) were included in a per-protocol analysis (20 did not complete the study and 59 were excluded from the analysis). In the 500-ml group, 32.2% received catheterization (114 of 354) compared to 13.4% (49 of 367) in the 800-ml group (relative risk, 0.4; 95% CI, 0.3 to 0.6; P < 0.0001). The authors found no difference between groups in any secondary outcome. CONCLUSIONS: In fast-track THA and TKA, a catheterization threshold of 800 ml significantly reduced the need for postoperative urinary catheterization, without increasing urological complications. This large randomized, controlled trial may serve as a basis for evidence-based guidelines on perioperative urinary bladder management.

Incidence of and risk factors for postoperative urinary retention in fast-track hip and knee arthroplasty.

BACKGROUND AND PURPOSE: Postoperative urinary retention (POUR) is a clinical challenge, but there is no scientific evidence for treatment principles. We describe the incidence of and predictive factors for POUR in fast-track total hip (THA) and knee arthroplasty (TKA). PATIENTS AND METHODS: This was a prospective observational study involving 1,062 elective fast-track THAs or TKAs, which were performed in 4 orthopedics departments between April and November 2013. Primary outcome was the incidence of POUR, defined by postoperative catheterization. Age, sex, anesthetic technique, type of arthroplasty, and preoperative international prostate symptom score (IPSS) were compared between catheterized and non-catheterized patients. RESULTS: The incidence of POUR was 40% (range between departments: 30-55%). Median bladder volume evacuated by catheterization was 0.6 (0.1-1.9) L. Spinal anesthesia increased the risk of POUR (OR = 1.5, 95% CI: 1.02-2.3; p = 0.04) whereas age, sex, and type of arthroplasty did not. Median IPSS was 6 in non-catheterized males and 8 in catheterized males (p = 0.02), but it was 6 in the females in both groups (p = 0.4). INTERPRETATION: The incidence of POUR in fast-track THA and TKA was 40%, with spinal anesthesia and increased IPSS in males as predictive factors. The large variation in perioperative bladder management and in bladder volumes evacuated by catheterization calls for randomized studies to define evidence-based principles for treatment of POUR in the future.

Reduction in lower urinary tract mucosal microtrauma as an effect of reducing eyelet sizes of intermittent urinary catheters.

Intermittent catheterization (IC) utilizing conventional eyelets catheters (CECs) for bladder drainage has long been the standard of care. However, when the tissue of the lower urinary tract comes in close proximity to the eyelets, mucosal suction often occurs, resulting in microtrauma. This study investigates the impact of replacing conventional eyelets with a drainage zone featuring multiple micro-holes, distributing pressure over a larger area. Lower pressures limit the suction of surrounding tissue into these micro-holes, significantly reducing tissue microtrauma. Using an ex vivo model replicating the intra-abdominal pressure conditions of the bladder, the intra-catheter pressure was measured during drainage. When mucosal suction occurred, intra-catheter images were recorded. Subsequently affected tissue samples were investigated histologically. The negative pressure peaks caused by mucosal suction were found to be very high for the CECs, leading to exfoliation of the bladder urothelium and breakage of the urothelial barrier. However, a micro-hole zone catheter (MHZC) with a multi-eyelet drainage zone showed significantly lower pressure peaks, with over 4 times lower peak intensity, thus inducing far less extensive microtraumas. Limiting or even eliminating mucosal suction and resulting tissue microtrauma may contribute to safer catheterizations in vivo and increased patient comfort and compliance.

New micro-hole zone catheter reduces residual urine and mucosal microtrauma in a lower urinary tract model.

Urinary tract infections (UTIs) are the main complication associated with clean intermittent catheterization (CIC) and are facilitated by post-void residual urine and trauma to the mucosa during voiding. The risk of UTI may be diminished by reducing the residual volumes and preventing microtrauma caused by mucosal suction through the eyelets of conventional eyelet catheters (CEC). A new micro-hole zone catheter (MHZC) was developed and tested in an ex vivo porcine lower urinary tract model and in vivo, in pigs, against a CEC. It was shown that, irrespective of the micro-hole diameter, the new catheter ensured increased flowrates and significantly lower residual volumes at the first flow-stop. Furthermore, with a micro-hole diameter of 0.4 mm, mucosal suction was virtually eliminated, regardless of the insertion depth or simulated intra-abdominal pressure mimicking sitting or standing humans. Pressure profile experiments and endoscopy studies indicated that the bladder gradually folds against the drainage tip of the new catheter, without blocking the flow, and, unlike with the CEC, sharp pressure variations and flow-stops did not occur during voiding. The MHZC outperformed the CEC in all tested scenarios and decreased residual volumes, thus potentially decreasing the risk of UTIs.

Renal Disease in Metabolic Syndrome: the Hidden Role of Intrarenal Ischemia.

Introduction: The pathogenesis of renal disease in obesity and metabolic syndrome (MS) is mostly unknown. This is in part because of the limited information about renal morphological changes in these conditions. We evaluated renal histology in subjects with MS and those without MS, who are participants in the European Nephrectomy Biobank (ENBiBA) project. Methods: MS was defined with at least 3 of the following criteria: (i) body mass index (BMI) ≥27 kg/m2; (ii) prediabetes: fasting glucose of 100-125 mg/dl or HbA1c >5.7%; (iii) systolic or diastolic blood pressure >140/90 mm Hg or the use of medications; and (iv) triglycerides >150 mg/dl or high-density lipoprotein cholesterol <40 (in men) or 50 mg/dl (in women). The absence of these criteria defined patients without MS. Exclusion criteria were diabetes or known causes of renal disease. Results: A total of 157 cases were evaluated: 49 without and 108 with MS. Those with MS were older (54 ± 16 vs. 66 ± 11, P < 0.0001), had more prevalent chronic kidney disease (CKD, estimated glomerular filtration rate [eGFR] <60 ml/min): 24% (23%) versus 4% (8%) (P = 0.02), and had higher albumin-to-creatinine ratio (10 [4-68] vs. 4.45 [0-27], P = 0.05) than those without MS. Global sclerosis (3% [1-7] vs. 7% [3-13], P < 0.0001), nodular sclerosis, mesangial expansion, glomerulomegaly; moderate + severe hyalinosis, and arteriosclerosis were more frequent in those with MS than in those without (88 [82] vs. 29 [59]; 83 [77] vs. 30 [61]; P < 0.05). These vascular changes were independent of differences in age. Conclusion: In MS, ischemic renal disease may play a role in renal disease. In addition, some patients may develop lesions compatible with diabetic nephropathy such as increased mesangial expansion and nodular sclerosis. Further analyses are needed to study the consequences of the pandemic of obesity on renal health.

A prospective, randomized, crossover, multicenter study comparing quality of life using compact versus standard catheters for intermittent self-catheterization.

PURPOSE: Intermittent catheterization is the recommended standard treatment for neurogenic bladder dysfunction. However, standard intermittent catheters can be unwieldy, difficult to use and carry discreetly. This can influence patient ability to perform catheterization efficiently, discreetly and privately, therefore, affecting patient quality of life. We evaluated whether the discreet design of the compact catheter would improve quality of life in intermittent catheterization users compared with standard catheters. MATERIALS AND METHODS: We performed a nonblinded, randomized, multicenter, 2-way crossover study with 2 treatment periods of 6 weeks ± 3 days. A total of 125 patients with neurogenic bladder dysfunction were included in the study from 17 study sites, including 7 in France, 3 each in Germany, Denmark and Sweden, and 1 in Norway. Quality of life was evaluated by the intermittent self-catheterization questionnaire. The difference in questionnaire scores between the compact catheter and standard hydrophilic coated catheters was analyzed using a mixed linear normal model. RESULTS: The intermittent catheterization questionnaire score increased significantly due to compact catheter use. We noted an estimated mean difference of 17.0 between the compact and standard intermittent catheters (p <0.001), corresponding to a 28% increase. The primary study results were further supported by the positive results of the secondary objective of preference, that is 63% of patients preferred the compact catheter. CONCLUSIONS: The discreet design of the compact catheter significantly improved patient quality of life related to intermittent self-catheterization.

Robot-assisted laparoscopic radical cystectomy with intracorporeal ileal conduit diversion versus open radical cystectomy with ileal conduit for bladder cancer in an ERAS setup (BORARC): protocol for a single-centre, double-blinded, randomised feasibility study.

BACKGROUND: Radical cystectomy (RC) with urinary diversion is the recommended treatment for selected cases of non-metastatic high-risk non-muscle-invasive and muscle-invasive bladder cancer. It remains unknown whether robot-assisted laparoscopic cystectomy (RARC) offers any advantage in terms of safety compared to open cystectomy (ORC) in an Enhanced Recovery After Surgery (ERAS) setup. Blinded randomised controlled trials (RCTs) between RARC versus ORC have never been conducted in cystectomy patients. We will investigate the feasibility of conducting a double-blinded RCT comparing ORC with RARC with intra-corporal ileal conduit (iRARC) in an ERAS setup. METHODS: This is a single-centre, double-blinded, randomised (1:1) clinical feasibility study for patients with non-metastatic high-risk non-muscle-invasive or muscle-invasive bladder cancer scheduled for cystectomy. All participants are recruited from Rigshospitalet, Denmark. The planned sample size is 50 participants to investigate whether blinding of the surgical technique is feasible. Participants and postoperative caring physicians and nurses are blinded using a pre-study designed abdominal dressing and blinding of the patient's electronic health record. Study endpoints are assessed 90 days postoperatively. The primary aim is to study the frequency and pattern of unplanned unblinding after surgery and the number of participants who cannot guess the surgical technique at the day of discharge. Eleven secondary endpoints are assessed: length of stay, days alive and out of hospital, in-hospital complication rate, 30-day complication rate, 90-day complication rate, readmission rate, quality of life, blood loss, pain, rate of moderate/severe post-anaesthesia care unit (PACU) complications, and delirium. Participants are managed in an ERAS setup in both arms of the trial. DISCUSSION: We report on the design and objectives of a novel experimental feasibility study investigating whether blinding of the surgical technique in cystectomy patients is possible. This information is essential for the design of future blinded trials comparing ORC to RARC. There is a continued need to compare RARC and ORC in terms of both efficacy, safety, and oncological outcomes. Estimated end of study is March 2021. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT03977831. Registered on the 6th of June 2019.

Urethral pressure reflectometry; a novel technique for simultaneous recording of pressure and cross-sectional area: a study of feasibility in the prostatic urethra.

UNLABELLED: What's known on the subject? and What does the study add? In the 1980s and 1990s, a method for direct measurement of pressure and cross-sectional area in women and men was developed. It was successful in terms of obtaining meaningful results in several studies. But the technique, which was based on the field gradient principle, was never implemented in the clinical setting because of technical limitations. In 2005, urethral pressure reflectometry was introduced as a new technique in female urodynamics. The technique has been shown to be more reproducible than conventional urethral pressure profilometry, when measuring incontinence in women. In 2010 it was also introduced as a new measuring technique in the anal canal. This study, adds a new and interesting technique to the field of male urodynamics. For the first time, sound waves have been used to measure pressure and cross-sectional area simultaneously, directly in the prostatic urethra. The results from this first trial with urethral pressure reflectometry are promising, in terms of obtaining meaningful physiological parameters. Our hope is that, future trials will help us to be able to identify specific areas of obstruction or rigidity in the prostatic urethra, making treatment more direct and side effects from surgery less severe. However, further studies are needed to evaluate the technique with regards to clinical usefulness in men with benign prostatic obstruction. OBJECTIVE: Urethral Pressure Reflectometry (UPR) was introduced in 2005, and it has since been used in the female urethra for simultaneous measurement of pressure (P) and cross-sectional area (CA). It has shown to be more reproducible than conventional pressure measurement and reintroduced direct measurement of pressure and elastance in the urethra as important parameters when assessing incontinent women. To test the feasibility of UPR in the prostatic urethra. PATIENTS AND METHODS: We tested the technique in ten male patients, median age 73 and range 51-91. Measurements were performed in the supine position, with less than 50 ml of urine in the bladder. The UPR valuables measured were opening and closing pressure, opening and closing elastance and hysteresis. RESULTS: The PVC tube was easy to insert to the same degree as a normal KAD. Opening pressure and opening elastance were measured on all patients. The sphincter area was easily identified during measurements. UPR provides results compatible with previous techniques. A standardized method for measurements was developed. CONCLUSION: UPR has been shown feasible in the prostatic urethra. Further studies on healthy volunteers and patients with lower urinary tract symptoms and benign prostatic obstruction (BPO) are needed, to determine if UPR has a future role in urodynamic diagnostics of male patients with BPO.

Development of an ex-vivo porcine lower urinary tract model to evaluate the performance of urinary catheters.

Intermittent catheterization is the gold standard method for bladder management in individuals with urinary retention and/or incontinence. It is therefore important to understand the performance of urinary catheters, especially on parameters associated to risks of developing urinary tract infections, and that may impact the quality of life for urinary catheter users. Examples of such parameters include, urine flowrate, occurrence of flow-stops, and residual urine left in the bladder after flow-stop. Reliable in-vitro and/or ex-vivo laboratory models represent a strong asset to assess the performance of urinary catheters, preceding and guiding in-vivo animal studies and/or human clinical studies. Existing laboratory models are generally simplified, covering only portions of the catheterization process, or poorly reflect clinical procedures. In this work, we developed an ex-vivo porcine lower urinary tract model that better reflects the catheterization procedure in humans and allows to investigate the performance of standard of care catheters. The performance of three standard of care catheters was investigated in the developed model showing significant differences in terms of flowrate. No differences were detected in terms of residual volume in the bladder at first flow-stop also when tuning the abdominal pressure to mimic a sitting down and standing up position. A newly discovered phenomenon named hammering was detected and measured. Lastly, mucosal suction was observed and measured in all standard of care catheters, raising the concern for microtrauma during catheterization and a need for new and improved urinary catheter designs. Results obtained with the ex-vivo model were compared to in-vivo studies, highlighting similar concerns.

von Hippel-Lindau disease: Updated guideline for diagnosis and surveillance.

von Hippel Lindau disease (vHL) is caused by a hereditary predisposition to multiple neoplasms, especially hemangioblastomas in the retina and CNS, renal cell carcinomas (RCC), pheochromocytomas, neuroendocrine pancreatic tumours (PNET) and endolymphatic sac tumours. Evidence based approaches are needed to ensure an optimal clinical care, while minimizing the burden for the patients and their families. This guideline is based on evidence from the international vHL literature and extensive research of geno- and phenotypic characteristics, disease progression and surveillance effect in the national Danish vHL cohort. We included the views and preferences of the Danish vHL patients, ensured consensus among Danish experts and compared with international recommendations. RECOMMENDATIONS: vHL can be diagnosed on clinical criteria, only; however, in most cases the diagnosis can be supported by identification of a pathogenic or likely pathogenic variant in VHL. Surveillance should be initiated in childhood in persons with, or at risk of, vHL, and include regular examination of the retina, CNS, inner ear, kidneys, neuroendocrine glands, and pancreas. Treatment of vHL manifestations should be planned to optimize the chance of cure, without unnecessary sequelae. Most manifestations are currently treated by surgery. However, belzutifan, that targets HIF-2α was recently approved by the U.S. Food and Drug Administration (FDA) for adult patients with vHL-associated RCC, CNS hemangioblastomas, or PNETs, not requiring immediate surgery. Diagnostics, surveillance, and treatment of vHL can be undertaken successfully by experts collaborating in multidisciplinary teams. Systematic registration, collaboration with patient organisations, and research are fundamental for the continuous improvement of clinical care and optimization of outcome with minimal patient inconvenience.

Safety of a new compact male intermittent catheter: randomized, cross-over, single-blind study in healthy male volunteers.

INTRODUCTION: A new compact male intermittent catheter was compared with a regular intermittent male catheter in terms of safety and acceptability. METHODS: In this randomized, single-blind, cross-over study, healthy male volunteers were catheterized twice with a compact catheter and twice with a regular catheter. RESULTS: 28 participants were enrolled. Mean ± SD discomfort (visual analogue scale; primary objective) was 2.25 ± 1.5 and 2.52 ± 1.8 for the compact and regular catheters, respectively (difference -0.27; 95% confidence interval -0.73 to 0.19); there was no significant difference in hematuria (p = 0.54) or discomfort/stinging/pain at first micturition (p = 0.56). During insertion, handling was easier (p = 0.0001) and touching the coating was necessary less often (2.2 vs. 81.3% of catheterizations; p < 0.0001) with the compact catheter; it was preferred by nurses for 20 of 23 participants. No adverse events were reported. CONCLUSIONS: Short-term safety of the new compact catheter was at least as good as that of the regular male intermittent catheter and handling was improved.

[Pregnant woman with renal cancer treated with simultaneous section and partial nephrectomy].

This is a case report of a 43-year-old pregnant woman, who in 26+0 was referred to a department of urology on suspicion of a kidney tumor. A CT scan of chest and abdomen showed a 7 cm tumor in the right kidney without signs of metastases. Biopsy revealed a clear cell renal cell carcinoma. The patient was treated in week 32+0 by a joint venture between a department of urology and a department of obstetrics with a midline incision caesarean followed by a right-sided open partial nephrectomy. The delivery of the baby was uncomplicated. The patient showed no signs of relapse in her control regiment after 1,5 years of observation.

Hypercalcemia After Cosmetic Oil Injections: Unraveling Etiology, Pathogenesis, and Severity.

Intramuscular injections of paraffin oil can cause foreign body granuloma formation and hypercalcemia. Macrophages with the ability to produce high levels of 1,25(OH)2 D3 may induce the mineral disturbance, but no major series of patients have been published to date. Here, medical history, physical evaluation, biochemical, and urinary analysis for calcium homeostasis were obtained from 88 males, who 6 years previously had injected paraffin or synthol oil into skeletal muscle. Moreover, granuloma tissue from three men was cultured for 48 hours ex vivo to determine 1,25(OH)2 D3 production supported by qPCR and immunohistochemistry of vitamin D metabolism and immune cell populations after treatment with 14 different drugs. The 88 men were stratified into men with hypercalcemia (34%), whereas normocalcemic men were separated into men with either normal (42%) or suppressed parathyroid hormone (PTH) (24%). All men had high calcium excretion, and nephrolithiasis was found in 48% of hypercalcemic men, 22% of normocalcemic men with normal PTH, and 47% of normocalcemic men with suppressed PTH. Risk factors for developing hypercalcemia were oil volume injected, injection of heated oil, high serum interleukin-2 receptor levels, and high urine calcium. High 1,25(OH)2 D3 /25OHD ratio, calcium excretion, and low PTH was associated with nephrolithiasis. The vitamin D activating enzyme CYP27B1 was markedly expressed in granuloma tissue, and 1,25(OH)2 D3 was released in concentrations corresponding to 40% to 50% of the production by human kidney specimens. Dexamethasone, ketoconazole, and ciclosporin significantly suppressed granulomatous production of 1,25(OH)2 D3 . In conclusion, this study shows that injection of large oil volumes alters calcium homeostasis and increases the risk of nephrolithiasis. Hypercalciuria is an early sign of disease, and high granulomatous 1,25(OH)2 D3 production is part of the cause. Prospective clinical trials are needed to determine if ciclosporin, ketoconazole, or other drugs can be used as prednisolone-sparing treatment. © 2020 American Society for Bone and Mineral Research (ASBMR).

Couple Counseling and Pelvic Floor Muscle Training for Men Operated for Prostate Cancer and for Their Female Partners: Results From the Randomized ProCan Trial.

INTRODUCTION: Patients with prostate cancer (PC) who undergo radical prostatectomy (RP) experience impaired sexual and urinary function. AIM: To compare the effect of early couple counseling and pelvic floor muscle training (PFMT) with usual care for sexual and urinary dysfunction after RP. METHODS: The ProCan study was a randomized controlled trial (RCT) with two parallel treatment arms and 1:1 allocation. Between January 2016 and December 2017, candidates for RP were invited to a longitudinal questionnaire study and provided baseline measures before surgery. Patients who underwent RP, had a female partner, and were sexually active were invited to the ProCan RCT. Couples who provided informed consent were allocated to usual care or usual care and up to six couple counseling sessions, up to three instructions in PFMT and a video home-training program. All couples filled in follow-up questionnaires at 8 and 12 months and non-participants provided 12 months' follow-up. Linear mixed-effect models and 95% confidence intervals were used to measure effects of the intervention. MAIN OUTCOME MEASURE: Primary outcome was erectile function, measured with The International Index of Erectile Function, at 8 and 12 months follow-up. Secondary outcomes were sexual and urinary function and use of treatment for erectile dysfunction (ED) by patients; sexual function in female partners; and relationship function, health-related quality of life, anxiety, depression, and self-efficacy in both patients and female partners. RESULTS: Thirty-five couples were randomized. No significant effect of the intervention was found on erectile function at 8 months (estimated difference in change, 1.41; 95% CI; -5.51 ; 8.33) or 12 months (estimated difference in change, 0.53; 95% CI; -5.94; 6.99) or in secondary outcomes, except for significantly increased use of ED treatment at 8 months. CONCLUSION: We found no effect of early couple counseling and PFMT, possibly because of the limited number of participants. Karlsen RV, Bidstrup PE, Giraldi A, et al. Couple Counseling and Pelvic Floor Muscle Training for Men Operated for Prostate Cancer and for Their Female Partners. Results From the Randomized ProCan Trial. Sex Med 2021;9:100350.