Efficacy of methenamine with methylthioninium in the treatment of dysuria: a randomized clinical study.

INTRODUCTION AND HYPOTHESIS: Dysuria is a common symptom present in several urological and gynecological conditions. Management relies on the underlying disease but may require additional symptomatic treatment. This study evaluated the combination of methenamine 250 mg and methylthioninium chloride 20 mg in the treatment of dysuria versus phenazopyridine. METHODS: This was a multicenter, single-blind, randomized, superiority clinical trial, including individuals over 18 with dysuria and a score ≥ 5 points on the pre-treatment categorical scale for pain. The primary outcome was the proportion of participants presenting excellent clinical response within 24 h after treatment. Improvement up to 72 h, time to reach improvement, sustained healing, investigators' opinion, and safety were also evaluated. RESULTS: Three hundred and fifteen participants were evaluated. Demographic characteristics and symptoms of dysuria were comparable between groups at baseline. The difference in the excellent response rate between treatments within 24 h was 12.7% (95% CI 6.16, 19.21) for pain, 9.4% (95% CI 3.32, 15.39) for burning, and 12.7% (95% CI 6.37, 18.99) for burning on urination, all in favor of the test drug, which was also superior from 36 to 48 h. Treatments were similar concerning time to reach the absence of symptoms and in the percentage of participants with sustained healing after 72 h. CONCLUSIONS: The association of methenamine with methylthioninium is superior to phenazopyridine in the treatment of dysuria.

The effect of preoperative phenazopyridine on short-term urinary retention following urogynecologic surgery.

INTRODUCTION AND HYPOTHESIS: Previous studies have found that administration of phenazopyridine decreased short-term urinary retention following surgery but other more recent trials have shown mixed results. This study sought to investigate the potential benefit of preoperative administration of oral phenazopyridine in relation to the prevention of short-term urinary retention following urogynecologic surgery. METHODS: This is a retrospective cohort study of a convenience sample of women undergoing urogynecologic surgery from June 2016 to March 2019. Following surgery, subjects underwent a standardized retrograde voiding trial. The data had previously been gathered from a prior prospective trial at our institution (Kesty et al. Int Urogynecol J 31(9):1899-1905, 11). Chart review was performed to determine whether patients that received 200 mg of preoperative oral phenazopyridine to better visualize ureteral efflux during cystourethroscopy were more or less likely to pass their postoperative voiding trial. Bivariate statistical analysis was performed as well as a multivariate logistic regression model. RESULTS: A total of 165 subjects were included in the final analysis; 100 who did not receive preoperative phenazopyridine and 65 who did receive phenazopyridine. There was no statistical difference between voiding trial pass rates following urogynecologic surgery between those who did not receive preoperative phenazopyridine compared to those who did [77% (77/100) and 82% (53/65), respectively, p = 0.37)]. The multivariate logistic regression model demonstrated no difference in postoperative voiding trial pass rates among those who received preoperative phenazopyridine compared to those who did not (OR 1.7, 95% CI: 0.53, 5.8). CONCLUSIONS: Preoperative administration of oral phenazopyridine does not decrease short-term urinary retention following urogynecologic surgery.

Opioid Free Ureteroscopy: What is the True Failure Rate?

OBJECTIVE: To determine the true failure rate of opioid free ureteroscopy (OF-URS) and rates of new-persistent opioid use utilizing a national prescription drug monitoring program. MATERIAL AND METHODS: We identified 239 patients utilizing our retrospective stone database who underwent OF-URS from Februrary 2018-March 2020. In Feb 2018, we initiated a OF-URS pathway (diclofenac, tamsulosin, acetaminophen, pyridium and oxybutynin). Patients who had a contraindication to NSAIDs were excluded from primary analyses. A prescription drug monitoring program was then utilized to determine the number of patients who failed OF-URS (defined as receipt of an opioid within 31 days of surgery) as well as rates of new-persistent opioid use (defined as receipt of opioid 91-180 days after surgery). All statistical analyses were performed using SAS 9.4. Tests were 2-sided and statistical significance was set at P<0.05. RESULTS: We found a OF-URS failure rate of 16.6% and 14.0% in the total and opioid naïve cohorts, respectively. Rates of new-persistent opioid use were 0.9% and 1.2%, respectively (lower than published expected rate of ~6% after URS with postoperative opioids). 91% of patients obtained opioid from alternative sources. Uni/multivariate analyses were performed for both cohorts. In the total cohort, benzodiazepine users had a lower risk of OF-URS failure on multivariate analysis. No variables were associated with OF-URS failure in the opioid naïve cohort. CONCLUSION: The true failure rate of OF-URS is higher than previously thought at 16.6% and 14.0%. However, efforts to reduce opioid prescriptions with OF-URS pathways have successfully reduced new-persistent opioid use.

Comparison of the Efficacy of Oxybutynin, Phenazopyridine, Celecoxib, and Placebo in the Treatment of Urinary Tract Symptoms after BCG Therapy in Patients with Bladder Tumors.

PURPOSE: Intravesical BCG (Bacillus Calmette-Guérin) therapy is indicated as an effective treatment for patients with non-muscle-invasive bladder cancer, despite associate with the side effects. In this study, the incidence of BCG therapy adverse effects was compared among three groups of patients who received celecoxib, phenazopyridine, and oxybutynin with placebo. MATERIALS AND METHODS: The randomized controlled clinical trial was conducted on four groups using the parallel group method. A checklist is used for weekly assessment of urinary symptoms, systemic symptoms of BCG therapy, and adverse drug reactions. RESULTS: The study included 120 patients, 10 female and 110 male. The mean age 59.65 ± 6.2 years. The results of multivariate analysis show that there is a significant decrease in urinary frequency for patients who received phenazopyridine (95% CI: 0.09, 0.31, OR = 0.17, P <.001) and also celecoxib group (95% CI: 0.10, 0.43, OR = 0.21, P <.001) compared to those in placebo group. Patients in celecoxib group (95% CI: 0.02, 0.07 ,OR = 0.04, P <.001), phenazopyridine (95% CI : 0.07, 0.37,OR=0.16, P <.001) and oxybutynin (95% CI: 0.02, 0.12,OR = 0.05, P <.001) were less likely to have urgency than those in placebo. Moreover, significant decrease was found for dysuria in the three treatment groups in comparison with placebo group. CONCLUSION: According to the results, celecoxib, phenazopyridine and oxybutynin can effectively decrease the side effects of BCG immunotherapy compared to placebo. Among these three treatments, the most effective and safest treatment option is celecoxib.

[Influence of phenazopyridine on the well-being of patients during and after cystoscopy].

INTRODUCTION: Cystoscopy is one of the most common procedures in urology. There is no single approach to pain relief. In the literature, there are conflicting data on the efficiency of intra-urethral gels. The use of non-steroidal anti-inflammatory drugs, intravenous sedation, and nitric oxide analgesia has been described. Phenazopyridine has been known for a long time. Acting on the bladder mucosa, it has a local analgesic effect. AN evaluation of phenazopyridine intake prior to cystoscopy in order to decrease pain during procedure and facilitate subsequent urination was performed. MATERIALS AND METHODS: A total of 97 patients were included in the study. Indications for cystoscopy were as following: hematuria, lower urinary tract symptoms/pain, a need to remove ureteral stent. The patients were randomized into two groups. In the main group (n=50), phenazopyridine 200 mg was administered 20 minutes before cystoscopy and then at a dose of 200 mg every 8 hours (in total three doses) in combination with lidocaine gel. In the control group (n=47), only lidocaine gel was used. Heart rate was measured before and after the procedure. All patients were asked to complete a visual analogue scale (VAS) 3, 8 and 24 hours after cystoscopy with the assessment of the first urination. RESULTS: After cystoscopy, the difference between groups in VAS score was 27.7% in favor of the main group (p<0.001). After 3 hours, the average score in the main group was two times less than in the Control (p=0.012), while 3 and 8 hours after cystoscopy, the proportion of "zero" results was 10% and 0%, 28% and 4%, respectively, p<0.005. The heart rate after the procedure in the main group was 75.1 beats/min, compared to 77.9 beats/min in the control group (p=0.016). CONCLUSION: The intake of phenazopyridine allows to reduce pain intensity during and after cystoscopy and alleviate pain during first urination.

Pyelonephritis following phenazopyridine use.

We present a case of pyelonephritis following the extended andsolitary use of over-the-counter phenazopyridine in a forty-year-oldfemale. The patient initially had uncomplicated cystitis signs andsymptoms which partially resolved with phenazopyridine and therefore she continued use. She presented to the emergency department with systemicsigns and symptoms of acute pyelonephritis. As phenazopyridine is devoidof antibacterial properties this allowed the lower urinary tractinfection to progress to acute pyelonephritis requiring intravenousantibiotics. Better patient education may preclude this complication.

Effects of Pipemidic Acid, Phenazopyridine HCL and Sodium Diclofenac on Pain Perception Following Endoscopic Urological Surgery: Double-blinded Randomized-Controlled Trial.

AIM: to evaluate the analgesic effect, the side effects and the safety of analgesics following endoscopic urological procedure. METHODS: eighty patients who underwent endoscopic urological surgery at Kardinah Hospital, Tegal from June to July 2015 were divided into four groups. The experimental group was administered analgesic for 4 days pipemidic acid (A) 400 mg bid, or phenazopyridine (B) 200 mg tid, or sodium diclofenac (C) 50 mg bid and the control (D) group was administered placebo tid for 4 days. The analgesic effects were assessed using Visual Analog Scale (VAS). Association between variables was assessed using Cramers V and Kruskall Wallis. RESULTS: the endoscopic urological procedures consisted of 30 patients for URS, 6 patients for lithotripsy, 17 patients for TURP, 24 patients for removal JJ stent and 3 patients for cystoscopy. The mean age of group A, B, C and D (control) was 50.1 (13.7), 50.7 (14.8), 49.1 (13.4), and 49.6 (14.3) years, respectively, and follow-up period was 7 days. The VAS score in all experimental groups was less than control group on day 1 to 7 following endoscopic urological procedures (p<0.05). In the experimental group, there was no difference between groups B and C (p>0.05). Group A demonstrated a more favourable analgesic effect than B and C (p<0.05). No serious side effects were detected in any of the cases. CONCLUSION: we conclude that oral analgesics are effective for pain relief following endoscopic urological surgery. Pipemidic acid was found to have a superior analgesic effect than phenazopyridine HCl and sodium diclofenac.

Urinary tract infections.

Clinical presentation helps differentiate between upper and lower urinary tract infections (UTIs). UTIs are classified as either complicated or uncomplicated. A complicated UTI is associated with an underlying condition that increases the risk of failing therapy. Primary laboratory tests for UTIs consist of urinalysis and urine culture. The most common pathogen for uncomplicated cystitis and pyelonephritis is Escherichia coli. Nitrofurantoin, fosfomycin, and trimethoprim-sulfamethoxazole are first-line therapies for acute uncomplicated cystitis. Decisions regarding antibiotic agents should be individualized based on patients' allergies, tolerability, community resistance rates, cost, and availability.

Urinary tract analgesics for the treatment of patients with acute cystitis: where is the clinical evidence?

Acute cystitis is one of the most common health-related problems in the female population. Over the last few decades, a number of drugs labeled as 'urinary tract analgesics' were released; these are available over the counter and are gaining widespread resonance among the North American population. The main representatives of this class of drugs are phenazopyridine and methenamine hippurate. Methenamine's efficacy and side effects have been well studied in a recent systematic review. On the other hand, in contrast to its widespread use, the published clinical evidence regarding phenazopyridine's effectiveness and safety is scarce. In addition, consumers (potentially patients) appear to ignore the limitations of this kind of treatment. In this article, concerns regarding the use of over-the-counter uroanalgesics, with a focus on the relevant clinical evidence, are discussed.

Estudio de utilización de fenazopiridina en la atención médica ambulatoria en la seguridad social / Phenazopyridine: A drug utilization research in the Costa Rican Social Security

Justificación: fenazopiridina es un medicamento analgésico urinario oral; cuenta con una amplia experiencia histórica de uso y, bajo el paradigma de medicina basada en evidencia, tiene poco fundamento de alta calidad para sustentar su valor terapéutico. Objetivo: analizar el perfil de la utilización de la fenazopiridina en la práctica clínica habitual dentro de la Seguridad Social, a nivel de consulta ambulatoria, en los tres niveles de atención y por un periodo de 30 días. Procedimientos: en enero de 2011, en una unidad de cada nivel de atención: Área de Salud de Santa Bárbara, Clínica Dr. Carlos Durán y Hospital Dr. Calderón Guardia, se analizó el reporte de despacho por farmacia de la fenazopiridina, con el fin de preparar un perfil cuantitativo. En el análisis cualitativo de la prescripción, se revisó una muestra al azar de 30 expedientes de pacientes atendidos durante ese periodo en cada unidad, con un formulario prediseñado para el efecto. Resultados: durante 1 mes, tres unidades despacharon 381 prescripciones a los pacientes, mayormente mujeres. La prescripción varió entre 3 y 90 tabletas; la mayoría (60,43%) con solo 10 tabletas para tratamiento. Se documentó la anotación del medicamento y la dosis en un 54,55% de los expedientes. La dosis diaria prescrita (DDP) fue 100 mg TID, equivalente a 300 mg/d, en la mitad de los pacientes, y en las unidades del primer y segundo nivel de atención; seguida de 100 mg BID (33,33%). Un 54,55% de los pacientes tenían diagnóstico de infección del tracto urinario (89% mujeres); de estos, un 89,89% recibió también antibióticos. La duración varió entre 1 y 30 días, y se prolongó más en unidades del segundo y tercer nivel. Conclusión: la utilización es parcial y razonablemente adecuada, apoya el supuesto de efectividad seguridad, sobre todo en el contexto de la atención médica en el primero y segundo niveles de atención. La diversidad en los hábitos de prescripción requiere mejorar su empleo y desarrollar ...

Background: Phenazopiridine is an oral urinary tract analgesic; an extensive historical experience of use and, under the paradigm of evidence-based medicine, its therapeutic value is not supported by high quality explanations. Aim: To analyze the use of phenazopiridine in everyday clinical practice, at an ambulatory level, in the three different levels of attention in the Costa Rican social security during a period of 30 days. Methods: In January 2011, electronic pharmacy records from a first, second and third level health center; Health Area of Santa Barbara, Dr. Carlos Durán Clinic and Dr. Calderón Guardia Hospital, respectively, were obtained to establish the quantitative characteristics of the prescription of phenazopiridine. For the qualitative analysis of the prescription, a random sample of 30 medical records of patients treated during that period in each unit was considered using an instrument previously designed for said task. Results: During one month, three study units prescribed phenazopiridine to 381 patients, mostly females. Prescription varied from 3 to 90 tablets; most patients (60.43%) received only 10 tablets for their treatment regime. In 54.55% of the medical records, the diagnosis and prescription was documented. The daily-prescribed dose (DPD) was 100mg thrice a day, equivalent to 300mg per day in half of the patients; and in the first and second level of attention followed by 100mg twice a day (33.3%). A total of 55.4% of the patients had been diagnosed with urinary tract infection (89% female); of these an 89.9% received also antibiotic treatment. The duration of treatment varied between 1 to 30 days, with more prolonged use in the second and third level of attention. Conclusion: The use of phenazopiridine is partial and reasonably adequate, thus supporting the efficacy-safety criteria in the context of first and second level attention centers. The diversity in the prescription patterns requires improvement in ...

Phenazopyridine does not improve catheter discomfort following gynecologic surgery.

OBJECTIVE: We sought to determine if phenazopyridine improves pain in catheterized patients recovering from gynecologic surgery. STUDY DESIGN: This trial randomized 240 adult women, who were undergoing gynecologic surgery and requiring an indwelling Foley catheter, to placebo or phenazopyridine hydrochloride. Group assignment was masked by instillation of orange dye in the Foley bag of both groups. The primary outcome was the mean postoperative visual analog score (VAS). Secondary outcomes were pain medicine utilization and blinding efficacy. RESULTS: In all, 219 patients received study medications (112 phenazopyridine and 107 placebo). There was no significant difference in demographics, procedure type, bladder VAS, overall VAS, and pain medication use. Only 25 of the 45 participants who responded guessed their group assignment correctly, suggesting adequate blinding. CONCLUSION: Postoperative VAS scores and pain medicine usage did not change with using routine phenazopyridine following gynecology surgery. Colored dye adequately masks visual side effects of phenazopyridine.

Neurogenic bladder and chronic urinary retention associated with MDMA abuse.

INTRODUCTION: The use of 3,4-methylenedioxymethamphetamine (MDMA, known as "ecstasy"), a synthetic amphetamine and "club drug," has been associated with acute, transient urinary retention. We report a case of neurogenic bladder and chronic urinary retention associated with MDMA abuse. CASE REPORT: A 21-year-old male presented to the emergency department (ED) because he had abdominal pain and difficulty urinating. He had experienced difficulty in initiating urination over the past 1.5 months, with periods of 24 to 36 hours between voids and large volumes of urine. The patient had a chronic pattern of MDMA use, taking 4 tablets/day for 3 months. Two weeks before coming to the ED, he had been admitted to an inpatient drug rehabilitation center. During the time since that admission, the patient had visited EDs repeatedly for insertion and removal of Foley catheters to relieve the urinary retention until he could be admitted to a urologic service. Cystometrogram was abnormal, finding no sensation of bladder fullness after instillation of 350 mL of saline and inability to generate a voluntary voiding pressure. Cystoscopy revealed no outlet obstruction. The findings were consistent with neurogenic bladder. The patient was given prescriptions for bethanecol and phenazopyridine, and told to continue a 10-day course of sulfamethoxazole/trimethoprim for urinary tract infection. He was discharged with a Foley catheter in place. Symptoms of urinary retention persisted at 1-year follow-up, despite self-catheterization and complete cessation of MDMA use. CONCLUSION: Chronic MDMA use may lead to neurogenic bladder and chronic urinary retention.

A prospective, randomized, double-blinded placebo-controlled comparison of extended release oxybutynin versus phenazopyridine for the management of postoperative ureteral stent discomfort.

OBJECTIVES: Ureteral stents commonly cause lower urinary tract and flank discomfort. We evaluated the use of extended release oxybutynin versus phenazopyridine versus placebo for the management of ureteral stent discomfort after ureteroscopy. METHODS: Each of 60 patients who received a unilateral stent after ureteroscopy was given a blister pack containing 21 unmarked capsules of either extended release oxybutynin 10 mg, phenazopyridine 200 mg, or placebo in a prospective, randomized, and double-blinded fashion. Patients were instructed to take 1 capsule 3 times daily immediately after the procedure. Patients were given 50 tablets of oral narcotic to be taken as needed. Patients reported bothersome scores for flank pain, suprapubic pain, urinary frequency, urgency, dysuria, and hematuria on postoperative day 1, day 2, and the day of stent removal. Narcotic use was also recorded. RESULTS: Eight patients were excluded from the analysis for stent migration necessitating early removal (1), uncontrollable pain (1), failure to complete blister pack (4), and inability to contact for follow-up surveys (2). There was no difference in bothersome score among the groups for flank pain, suprapubic pain, urinary frequency, urgency, and dysuria. The phenazopyridine group reported less hematuria on postoperative day 1 when compared with placebo, which was statistically significant. The oxybutynin group required fewer narcotics, but this finding was not statistically significant. CONCLUSIONS: Although this study failed to show a significant difference in bothersome scores among the groups, the small sample size precludes definitive conclusion. Future studies pooling these data will determine the overall treatment effect and the optimal management of ureteral stent morbidity.

Interstitial cystitis/painful bladder syndrome.

Interstitial cystitis (IC) is a chronic, painful bladder syndrome primarily found in women. Although the direct cause(s) of IC are unknown, several theories exist. Common symptoms include urinary urgency, frequency, and pain. Treatment options include behavioral therapies, use of pharmacologic agents, and surgery. Patients benefit from prompt diagnosis and initiation of treatments. Important clinical features of IC in women including the pathology, common symptoms, and recommended evaluation and management strategies are reviewed.

Use of phenazopyridine for reducing discomfort during embryo transfer.

OBJECTIVE: The embryo transfer is a critical part of in vitro fertilization. When performed under abdominal ultrasound guidance, the embryo transfer procedure requires a full bladder. Patients often state that the discomfort of the distended bladder causes more pain than the actual transfer procedure. Phenazopyridine HCl is a bladder analgesic. The objective of this study was to determine if a single dose of phenazopyridine prior to embryo transfer reduces patient discomfort during that procedure. DESIGN: Prospective randomized double-blinded clinical trial. SETTING: University-based Reproductive Medicine practice. PATIENT(S): Eighty-five reproductive age infertile women undergoing in vitro fertilization. INTERVENTION(S): Phenazopyridine (200 mg) or placebo taken 1 hour prior to embryo transfer utilizing transabdominal sonography. MAIN OUTCOME MEASURE(S): Pain as assessed by visual analogue pain scale and physician and nurse assessment of patient discomfort. RESULT(S): Study groups were similar in their demographic background. Mean pain score as assessed by a visual analogue pain scale during the procedure was 2.95 +/- 2.4 in the placebo group, and 3.03 +/- 2.6 in the active medication group (NS). There were also no significant differences in the observations of pain assessments. CONCLUSION(S): Phenazopyridine used in a single dose prior to embryo transfer does not alleviate patient discomfort.

Multiple adverse effects of pyridium: a case report.

Pyridium (phenazopyridine hydrochloride) is often prescribed as an analgesic in patients following trauma, surgery, or infections of the urinary tract. Pyridium toxicity has been previously reported, however, most cases result in a single adverse effect. Herein the authors describe an elderly patient who presented with simultaneous multiple adverse effects, including a previously undocumented myelosuppressive pancytopenia.