Search

BackgroundHemorrhagic cystitis (HC) is an inflammatory disease of the bladder with sustained hematuria for which there is currently no approved drug treatment. We evaluated a liposomal tacrolimus preparation (LP-10) in patients with refractory moderate to severe sterile HC.MethodsThis phase 2a dose-escalation study assessed the safety and efficacy of up to 2 intravesical instillations of LP-10 (2, 4, or 8 mg tacrolimus) in 13 patients with HC. Primary efficacy outcomes were changes from baseline in the number of bleeding sites on cystoscopy, microscopic urine analysis for red blood cells (RBCs), and hematuria on dipstick. Additional efficacy measures included urinary incontinence, frequency, and urgency on a 3-day diary and cystoscopy global response assessment (GRA). Blood samples for pharmacokinetic (PK) assessment were obtained in all patients.ResultsIntravesical LP-10 was well tolerated, with no treatment-related severe or serious adverse events (AEs) and only 3 drug-related AEs (artificial urinary sphincter malfunction, dysuria, and bladder spasms). LP-10 blood levels showed short durations of minimal systemic uptake. Treatment resulted in significant improvements in bleeding on cystoscopy, RBC counts in urine, hematuria on dipstick, and urinary incontinence. Bleeding on cystoscopy and urinary incontinence showed dose-dependent improvements that were more pronounced in the 4 mg and 8 mg dose groups. All dose groups showed a significant improvement in cystoscopy GRA.ConclusionLP-10 was well tolerated, with clinically relevant efficacy seen in improvements in cystoscopic bleeding, hematuria, and urinary incontinence. The benefit-risk profile supports the further clinical development of LP-10 at a tacrolimus dose of 4 mg.

BACKGROUND: Hemorrhagic cystitis (HC) is an inflammatory disease of the bladder with sustained hematuria for which there is currently no approved drug treatment. We evaluated a liposomal tacrolimus preparation (LP-10) in patients with refractory moderate to severe sterile HC. METHODS: This phase 2a dose-escalation study assessed the safety and efficacy of up to 2 intravesical instillations of LP-10 (2, 4, or 8 mg tacrolimus) in 13 patients with HC. Primary efficacy outcomes were changes from baseline in the number of bleeding sites on cystoscopy, microscopic urine analysis for red blood cells (RBCs), and hematuria on dipstick. Additional efficacy measures included urinary incontinence, frequency, and urgency on a 3-day diary and cystoscopy global response assessment (GRA). Blood samples for pharmacokinetic (PK) assessment were obtained in all patients. RESULTS: Intravesical LP-10 was well tolerated, with no treatment-related severe or serious adverse events (AEs) and only 3 drug-related AEs (artificial urinary sphincter malfunction, dysuria, and bladder spasms). LP-10 blood levels showed short durations of minimal systemic uptake. Treatment resulted in significant improvements in bleeding on cystoscopy, RBC counts in urine, hematuria on dipstick, and urinary incontinence. Bleeding on cystoscopy and urinary incontinence showed dose-dependent improvements that were more pronounced in the 4 mg and 8 mg dose groups. All dose groups showed a significant improvement in cystoscopy GRA. CONCLUSION: LP-10 was well tolerated, with clinically relevant efficacy seen in improvements in cystoscopic bleeding, hematuria, and urinary incontinence. The benefit-risk profile supports the further clinical development of LP-10 at a tacrolimus dose of 4 mg.

Background Hypothesis/Objective Animals Methods Results Conclusions and Clinical Importance Recurrent bacterial cystitis, often referred to as recurrent urinary tract infection (UTI), can be difficult to manage and alternative treatments are needed.Intravesicular administration of asymptomatic bacteriuria (ASB) E. coli 212 will not be inferior to antimicrobial treatment for the management of recurrent UTI in dogs.Thirty‐four dogs with >1 UTI in the 12 months before presentation.All dogs were deemed normal otherwise based on absence of abnormalities on physical examination, CBC, serum biochemical panel, and abdominal ultrasonography. Dogs were randomized to 1 of 2 treatment groups: Group 1 antimicrobials for 7 days or group 2 intravesicular administration of ASB E. coli 212. Owners were provided a voiding questionnaire regarding their dogs' clinical signs, which was completed daily for 14 days to assess clinical cure. Dogs were examined on days 7 and 14 to assess clinical cure, and urine specimens were submitted for urinalysis and bacterial culture.Clinical cure rates for ASB E. coli 212–treated dogs were not inferior to 7 days of antimicrobial treatment with a 12% margin of difference to determine non‐inferiority. No significant difference was found between the treatment groups on days 7 and 14 in the proportion of dogs achieving ≥50% or ≥75% reduction in their clinical score compared with baseline.These data suggest that intravesicular administration of ASB E. coli 212 is not inferior to antimicrobials for the treatment of recurrent UTI in dogs. This biotherapeutic agent could help alleviate the need for antimicrobials for some dogs with recurrent UTI, improving antimicrobial stewardship. [ABSTRACT FROM AUTHOR]

Sensory bladder disorders encompass several distinct conditions with overlapping symptoms, which pose diagnostic challenges. This study aimed to evaluate urine biomarkers for differentiating between various sensory bladder disorders, including non-Hunner's interstitial cystitis (NHIC), detrusor overactivity (DO), hypersensitive bladder (HSB), and urodynamically normal women. A retrospective analysis of 191 women who underwent a videourodynamic study (VUDS) was conducted, with some also receiving cystoscopic hydrodistention to confirm the presence of NHIC. Participants were categorized into four groups: DO (n = 51), HSB (n = 29), NHIC (n = 81), and normal controls (n = 30). The urine levels of inflammatory and oxidative stress biomarkers were measured. The DO patients exhibited elevated IP-10 levels, while the HSB patients had decreased TAC and 8-OHdG levels. The NHIC patients showed lower IL-2 and higher TNF-α levels. A TNF-α ≥ 1.05 effectively identified NHIC, with an AUROC of 0.889, a sensitivity of 98.8%, and a specificity of 81.3%. An IP-10 ≥ 6.31 differentiated DO with an AUROC of 0.695, a sensitivity of 56.8%, and a specificity of 72.3%. An 8-OHdG ≤ 14.705 and a TAC ≤ 528.7 identified HSB with AUROCs of 0.754 and 0.844, respectively. The combination of 8-OHdG and TAC provided an AUROC of 0.853 for HSB. These findings suggest that TNF-α, IP-10, TAC, 8-OHdG, and IL-2 are promising non-invasive biomarkers for distinguishing between these conditions, which may improve diagnosis and management. [ABSTRACT FROM AUTHOR]

To determine the incidence of radiation cystitis on prostate cancer (PCa) patients undergoing pelvic radiotherapy (RT), evaluating the most used management strategies, and identifying potential risk factors associated with the development of this condition. A retrospective analysis was conducted using the PearlDiver Mariner database, containing patient records compiled between 2011 and 2022. International Classification of Diseases (ICD) and Current Procedural Terminology (CPT) codes were employed to identify population and outcomes. We evaluated patients who underwent RT for PCa and subsequently developed radiation cystitis. Primary objective was to determine the overall incidence of radiation cystitis. Furthermore, we investigated its associated risk factors and management. A total of 274,865 PCa patients underwent RT during the study period. Of these, 48,713 (17.7%) experienced hematuria following RT, while 7721 (2.8%) were diagnosed with radiation cystitis. After the diagnosis, 2307 patients (29.9%) received diagnostic or therapeutic endoscopic interventions. Only 59 patients (0.76%) underwent endovascular embolization, while 151 patients (1.95%) required cystectomy. Hyperbaric oxygen therapy, administered to 1287 patients (16.67%), was the only treatment that displayed a significant upward trend. Multivariate logistic regression identified obesity (OR 1.29; 95% CI 1.23-1.35), smoking (OR 1.27; 95% CI 1.22-1.33), and diabetes (OR 1.32; 95% CI 1.26-1.39), as significant risk factors for radiation cystitis (all P -values <.001). Radiation cystitis represents a rare complication after pelvic RT with significant clinical impact. Its incidence has remained stable throughout the study period. The identified risk factors corroborate the pathophysiology of radiation cystitis. Hyperbaric oxygen therapy was the only treatment to show an upward trend during the study period. [ABSTRACT FROM AUTHOR]

Urinary tract infections (UTI) are a common problem in childhood. The clinical presentation is variable depending on age and whether there is pyelonephritis or cystitis. UTI are diagnosed by culturing an appropriately collected urine sample. Most children with UTI can be managed safely with oral antibiotics irrespective of whether they have cystitis or pyelonephritis. Following a single UTI a significant proportion of children will develop recurrent UTI and many of these children will have identifiable risk factors. Treating children with recurrent UTI with repeated courses of antibiotics or long term prophylactic antibiotics puts patients at risk of infections with multi-resistant organisms. Furthermore recurrent UTI are also associated with the risk of renal parenchymal damage with long term health implications. It is therefore essential that management of children with UTI focuses not only on early diagnosis and treatment but also on UTI prevention. [ABSTRACT FROM AUTHOR]

Purpose: SARS‐CoV‐2 infection can result in genitourinary symptoms, such as frequency, urgency, nocturia, and pain/pressure. In this study, we followed the progression of overactive bladder (OAB) symptoms in patients that reported new or worsening OAB symptoms after coronavirus disease‐19 (COVID‐19) diagnosis. Materials and Methods: Individuals from a COVID‐19 serology study were invited to participate in a follow‐up study. Respondents were divided into three groups based on prior COVID‐19 testing. Patients scored symptoms retrospectively before the pandemic, at study onset, and prospectively during 12‐month follow‐up. Genitourinary symptoms were assessed using international consultation on incontinence questionaire for OAB (ICIQ‐OAB). Change in ICIQ‐OAB scores from baseline were calculated. The minimal important difference of one on ICIQ‐OAB is considered a significant change. Results: 26.0% of participants previously had positive COVID polymerase chain reaction (PCR) test (PCR+), 5.6% a positive serology test only (Ser+), and 65.5% were COVID naïve (COVID−). 23.8% of participants reported a significant increase in ICIQ‐OAB score at study onset compared to prepandemic. ICIQ‐OAB scores were similar at prepandemic but significantly higher at study start (p < 0.001) in PCR+ group. During follow‐up, change in ICIQ‐OAB scores from baseline remained unchanged for COVID− group, but gradually reduced for PCR+, reaching similar levels as COVID− group by 12 months. By 12 months, 71.4% of PCR+, 42.9% of Ser+, and 68.8% of COVID− participants still reported significant increase in ICIQ‐OAB scores. Conclusions: Most COVID‐19 patients experienced return of symptoms to baseline, indicative of the potential resolution of COVID‐associated cystitis. A subset of cases did not, raising questions about the underlying factors contributing to this outcome. Additional research is needed to assess long COVID on urological health. [ABSTRACT FROM AUTHOR]

Background: Urethral calculi causing acute urinary retention is a highly uncommon condition in women, which poses distinctive difficulties in diagnosis and treatment. This report presents the case of a 52-year-old woman who experienced acute urinary retention caused by a urethral stone. It emphasizes the effective use of minimally invasive methods and underscores the importance of comprehensive multidisciplinary treatment. Case presentation: A 52-year-old woman patient arrived with acute urinary retention symptoms that lasted 6 hours. She complained of pain in the perineal and periurethral regions. She struggled with poorly managed type 2 diabetes, metabolic syndrome, and frequent cystitis. The examination showed the presence of a 2-cm stone in the urethra. The treatment utilised retrograde propulsion and laser fragmentation. Postoperative magnetic resonance imaging results were normal, and follow-up care involved managing diabetes and adopting lifestyle changes to prevent the recurrence of cystitis and stones for 6 months. Conclusion: Urethral calculi exceptionally cause acute urinary retention in women. To achieve successful outcomes and prevent recurrence, it is crucial to prioritize prompt, minimally invasive treatment, and comprehensive management. [ABSTRACT FROM AUTHOR]

Background: Misuse and overuse of antibiotics comprise leading causes of antimicrobial resistance. The study aims to assess the pattern of antibiotic prescription among primary healthcare general practitioners in the South Batinah Governorate of Oman. Method: A cross-sectional study of 600 antibiotic prescriptions issued in the South Batinah Governorate in 2019 was conducted to verify the triggering diagnoses and determine the appropriateness of the prescribed antibiotic. Logistic regression analysis was used to determine the association between predictors and inappropriate use. Results: Respiratory infections accounted for 62% of antibiotic prescriptions, of which 92.2% were inappropriately prescribed. Extended-spectrum antibiotics were inappropriately prescribed in 33.3% of cystitis cases, while 14.3% of gastroenteritis received incorrect spectrum of antibiotics. Amoxicillin represented 46.2% of antibiotic prescriptions, of which 84.4% were unnecessarily prescribed. Lower inappropriate antibiotic prescribing rate was linked to patients ≥ 18 years (OR = 0.46, 95% CI: [0.26, 0.82]), those who underwent laboratory tests (OR = 0.22, 95% CI: [0.12, 0.39]), and consultations at health centers (OR = 0.44, 95% CI: [0.24, 0.79]). Arabic-speaking physicians were more likely to prescribe antibiotics inappropriately. Conclusion: Inappropriate antibiotic prescription was frequently observed in mild respiratory infections and associated with specific patient and physician characteristics. Appropriateness of antibiotic prescriptions issued can be improved through enhanced testing capacities as well as implementation of physician and community awareness campaigns. Highlights: • Inappropriate prescriptions were common among respiratory symptoms. • Amoxicillin was the most common antibiotic prescribed inappropriately. • Laboratory–tested patients were less likely to receive inappropriate antibiotics. • Inappropriate antibiotics were commonly prescribed by Arabic-speaking physicians. • Health centers' primary care physicians rarely prescribe inappropriate antibiotics. [ABSTRACT FROM AUTHOR]

Emphysematous cystitis is a rare bladder condition, with a relatively high mortality rate. There is no guideline, and only a few studies are available. An 85-year-old patient is diagnosed with this condition. He was treated successfully with an adequate approach. [ABSTRACT FROM AUTHOR]

Purpose: Chronic radiation cystitis (CRC) develops after radiation therapy and can present with symptoms like urinary frequency, urgency, pelvic pain, and nocturia. We have previously reported that amniotic bladder therapy (ABT) provides symptomatic improvement in refractory CRC patients for up to 3 months. Herein, we evaluated the durability of ABT up to 6 months. Materials and methods: CRC patients recalcitrant to previous treatments received ABT comprised of intra-detrusor injections of 100 mg micronized AM diluted in 10 mL 0.9% preservative-free sodium chloride. Clinical evaluation and questionnaires (Interstitial Cystitis Symptom Index (ICSI), Interstitial Cystitis Problem Index (ICPI), Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS), Overactive Bladder (OAB) Assessment Tool, SF-12 Health Survey) were repeated at pre-op and 2, 4, 8, 12, 16, 20, 24, and 36 weeks post-injection. Results: Five consecutive patients with a mean age of 64.4 ± 20.1 years with a median CRC duration of 10 years were included and followed for 6 months. After ABT, the lower urinary tract symptoms improved as early as 2 weeks and were maintained up to 20 weeks. BPIC significantly improved from 36.6 ± 1.1 at baseline to 12.6 ± 1.5 at 16 weeks and 13.8 ± 2.9 at 20 weeks. At 24 and 36 weeks, the improvement was maintained in four (80%) of the five patients (BPIC = 13.8 ± 1.0). Uroflow assessment showed voiding volume improved two-fold in four of the five patients at 24 weeks compared to baseline. Conclusion: Our data suggest that a significant number of CRC patients may have durable benefit after ABT. Despite this, some of them can show symptoms rebound at 24 weeks. [ABSTRACT FROM AUTHOR]