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.

[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.

Cost Analysis of Oral Phenazopyridine vs Intravesical Lidocaine for Preprocedural Analgesia for Intradetrusor OnabotulinumtoxinA Injections.

INTRODUCTION: Office administration of intradetrusor onabotulinumtoxinA is commonly used to treat overactive bladder. For preprocedure analgesia, either 50 mL 2% intravesical lidocaine instillation for 20 to 30 minutes or 200 mg oral phenazopyridine can be used. Phenazopyridine is associated with shorter appointment times and is noninferior to lidocaine for pain control in this setting. We performed a cost analysis of phenazopyridine vs lidocaine for analgesia before office intradetrusor onabotulinumtoxinA injection for the treatment of idiopathic overactive bladder. METHODS: A health care sector-perspective cost analysis was performed. The following assumptions were made: (1) similar efficacy of each medication in providing adequate analgesia, (2) similar physician ease of performing the procedure with either analgesic, and (3) similar patient satisfaction with either analgesic. Average cost of medications, adverse reactions, nursing tasks, and office visit time were found in publicly available data. Sensitivity analyses were performed using TreeAge Pro 2021, R1 software. RESULTS: Phenazopyridine is less costly compared to lidocaine per visit for office intradetrusor onabotulinumtoxinA injection ($827 vs $925). A difference of $98 per procedure provides a total annual cost savings of over $24 million if all procedures are performed with phenazopyridine instead of lidocaine. Sensitivity analysis showed that phenazopyridine remained less costly under most circumstances, and threshold analysis provided exact circumstances under which phenazopyridine is no longer cost saving. CONCLUSIONS: Phenazopyridine provides cost savings compared to lidocaine for analgesia before office intradetrusor onabotulinumtoxinA injection for the treatment of idiopathic overactive bladder. If adopted by providers nationwide, phenazopyridine may reduce health care spending and minimize office visit time while maintaining patient pain control and satisfaction.

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.

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.

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.

Urinary tract disorders. Clinical comparison of flavoxate and phenazopyridine.

In nine separate clinical trials, 382 patients having symptoms of either prostatitis, acute cystitis, urethritis, and/or trigonitis were randomly assigned to treatment with flavoxate or phenazopyridine. Over-all response was evaluated in 384 patients after five days of therapy. In patients having prostatitis, response was satisfactory in 66 per cent treated with flavoxate and 31 per cent treated with phenazopyridine. In all other patients, satisfactory responses were reported in 80 per cent on flavoxate compared with 56 per cent on phenazopyridine. Similarly, symptom-severity evaluations at two and five days of therapy showed most symptoms improved in more of the patients on flavoxate therapy than on phenazopyridine therapy. Although more adverse effects were reported in patients treated with phenazopyridine than with flavoxate, the difference between medications was not statistically significant.

Methaemoglobinaemia produced by phenazopyridine (Pyridium) in a man with chronic obstructive airways disease.

Life threatening methaemoglobinaemia developed after prolonged therapeutic use of phenazopyridine (Pyridium) in a patient with chronic obstructive airways disease. The combination of chronic obstructive airways disease and oxidant drugs (methaemoglobinaemia) may be lethal. The use of phenazopyridine should be abandoned. Certainly there is no indication to use it for more than a few days in any patient.

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.