-
American Journal of Obstetrics and... Aug 2022The efficacy of intradetrusor onabotulinumtoxinA injections for the management of idiopathic overactive bladder has been well-established. The injections are typically... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
The efficacy of intradetrusor onabotulinumtoxinA injections for the management of idiopathic overactive bladder has been well-established. The injections are typically performed in the office setting using local analgesia, most commonly a 20 to 30-minute intravesical instillation of lidocaine. There are limited data evaluating alternative bladder analgesics.
OBJECTIVE
To compare pain scores with preprocedure oral phenazopyridine vs intravesical lidocaine in women undergoing intradetrusor onabotulinumtoxinA injections for idiopathic overactive bladder.
STUDY DESIGN
Nonpregnant adult females with idiopathic overactive bladder, scheduled for office injection of 100 units of intradetrusor onabotulinumtoxinA were randomized to either 200 mg of oral phenazopyridine taken 1 to 2 hours preprocedure or a 20-minute preprocedure intravesical instillation of 50 mL of 2% lidocaine. We excluded participants with neurogenic bladders, and those who had received intradetrusor onabotulinumtoxinA injections in the previous 12 months. The primary outcome was pain measured by a 100-mm visual analog scale. Demographic characteristics and overall satisfaction with the procedure were also recorded. Providers answered questions about cystoscopic visualization, ease of procedure, and perception of participant comfort. Prespecified noninferiority margin was set to equal the anticipated minimum clinically important difference of 14 mm. A planned sample of 100 participants, 50 in each treatment arm, provided 80% power to detect noninferiority at a significance level of.05. We performed a modified intention-to-treat analysis and compared variables with the t test or the Fisher exact test.
RESULTS
A total of 111 participants were enrolled, and complete data were obtained for 100 participants; 47 participants were randomized to phenazopyridine and 53 to lidocaine. Baseline characteristics did not differ between groups. There were 19.6% and 20.8% of participants in the phenazopyridine and lidocaine groups, respectively, who previously underwent intradetrusor onabotulinumtoxinA injections. The mean postprocedure pain was 2.7 mm lower in the phenazopyridine group than in the lidocaine group (95% confidence interval, -11.3 to 10.7), demonstrating noninferiority. More than 90% of participants in both groups stated that the pain was tolerable. Slightly more participants reported being "very satisfied" in the lidocaine group, although this was not statistically significant (50.0% vs 40.4%; P=.34). Providers reported clear visualization in 89.4% of participants in the phenazopyridine group and in 100% of participants in the lidocaine group (P=.02). Provider perception of participant comfort and overall ease of procedure were not different between groups. Length of time in the exam room was significantly shorter in the phenazopyridine than in the lidocaine group (44.4 vs 57.5 minutes; P=.0003).
CONCLUSION
In women receiving intradetrusor onabotulinumtoxinA injections for idiopathic overactive bladder, oral phenazopyridine was noninferior to intravesical lidocaine for procedural pain control. Phenazopyridine is well-tolerated by participants, allows for the procedure to be performed with similar ease, and is associated with shorter appointment times.
Topics: Adult; Analgesia; Botulinum Toxins, Type A; Female; Humans; Lidocaine; Pain; Phenazopyridine; Treatment Outcome; Urinary Bladder; Urinary Bladder, Overactive
PubMed: 35580634
DOI: 10.1016/j.ajog.2022.05.025 -
Journal of Oncology Pharmacy Practice :... Mar 2020Phenazopyridine is a urinary tract analgesic indicated for short-term treatment of irritation in the lower urinary tract. Despite the lack of evidence for extended use,...
BACKGROUND
Phenazopyridine is a urinary tract analgesic indicated for short-term treatment of irritation in the lower urinary tract. Despite the lack of evidence for extended use, it is often used in varying durations for supportive care for cancer patients with radiation-induced cystitis. The objective of this study was to compare the incidence of adverse drug reactions in patients with radiation cystitis receiving long-term phenazopyridine (>14-day supply) compared to a matched comparator group.
METHODS
This retrospective cohort study compared adverse events among cancer patients with and without phenazopyridine exposure. Included patients received radiation and at least one chronic medication between 1 July 2008 and 30 June 2017. The phenazopyridine group also received >14-day supply of phenazopyridine during the study period. Patients were matched based on gender, age (±5 years), cancer diagnosis, and palliative or curative treatment intent. Data collection occurred at baseline, during the time of presumed exposure, and through the end of the study period for surveillance purposes.
RESULTS
A total of 272 patients received phenazopyridine for >14-day supply during the study period. Of these, 90 patients were included and matched to an equal number of patients in the comparator group. The included patients were similar between groups and were largely male with a diagnosis of prostate cancer. Most patients received between a 30- and 60-day supply of phenazopyridine. There were a total of 13 adverse drug reactions in the phenazopyridine group and 18 in the comparator group ( = 0.32). No differences were identified between the phenazopyridine and comparator groups for the incidence of individual adverse drug reactions, emergency department visits, hospitalizations, or new diagnoses of hepatocellular or colorectal cancer.
CONCLUSION
There was no difference in adverse drug reactions among patients receiving phenazopyridine for >14 days compared to a matched comparator group. The overall incidence of adverse events in both groups was low.
Topics: Aged; Cohort Studies; Cystitis; Drug Administration Schedule; Humans; Male; Middle Aged; Phenazopyridine; Radiation Injuries; Retrospective Studies
PubMed: 31006341
DOI: 10.1177/1078155219842646 -
International Urogynecology Journal Mar 2022Previous studies have found that administration of phenazopyridine decreased short-term urinary retention following surgery but other more recent trials have shown mixed...
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.
Topics: Clinical Trials as Topic; Cystoscopy; Female; Humans; Phenazopyridine; Postoperative Complications; Prospective Studies; Retrospective Studies; Urinary Retention
PubMed: 33580812
DOI: 10.1007/s00192-021-04699-w -
European Journal of Case Reports in... 2022Phenazopyridine is an over-the-counter urinary analgesic commonly used to alleviate the burning and urgency associated with lower urinary tract infections....
INTRODUCTION
Phenazopyridine is an over-the-counter urinary analgesic commonly used to alleviate the burning and urgency associated with lower urinary tract infections. Methaemoglobinaemia is an uncommon adverse effect of phenazopyridine use. We report a case of methaemoglobinaemia in a patient prescribed daily phenazopyridine to treat urethral and bladder irritation caused by a chronic indwelling Foley catheter.
CASE DESCRIPTION
A 55-year-old female resident of a long-term acute care facility with a chronic Foley, tracheostomy and ventilator-dependent respiratory failure was observed to have generalized dusky skin and hypoxia. Pulse oximetry was reading in the high 80s despite administration of 100% FiO2. ABG revealed paO2 of 451, oxyhaemoglobin level 75% and methaemoglobin level 22%. Medication review indicated that the patient was prescribed phenazopyridine 400 mg TID for the previous 2 months. This medication was discontinued. Considering she was chronically taking mirtazapine, she can increase risk of serotonin syndrome should she be administered first-line treatment with methylene blue. Vitamin C was thus instead administered as a second-line agent. Serial ABGs showed a rapid decline in methaemoglobin levels and an increase in oxyhaemoglobin within 2 days.
DISCUSSION
Acquired methaemoglobinaemia is a rare adverse effect of treatment with phenazopyridine. This risk increases when drug dosage and duration exceed manufacturer specifications. Treatment typically includes cessation of the offending drug and administration of methylene blue in severe cases. A thorough medication reconciliation should be performed prior to methylene blue initiation, as patients taking serotonergic medications (for example, MAOIs, SSRIs, SNRIs, TCAs) are at increased risk of serotonin toxicity with co-administration of methylene blue. In these instances, ascorbic acid/vitamin C can be chosen as an alternative treatment agent.
CONCLUSION
Work-up of refractory hypoxia should involve a thorough review of medications as even some over-the-counter drugs can cause the fatal side effect of methaemoglobinaemia. Treatment with vitamin C should be considered over methylene blue if serotonergic medications have been recently prescribed in order to avoid risk of serotonin syndrome.
LEARNING POINTS
Methaemoglobinaemia is an uncommon, life-threatening adverse effect of phenazopyridine use. Presentation depends on the severity of the disorder, ranging from headache, weakness, lightheadedness and dyspnoea, to arrhythmias, confusion, seizures and multiorgan failure.Workup of refractory hypoxia should involve a comprehensive medication review as even some over-the-counter drugs can cause methaemoglobinaemia.Management of methaemoglobinaemia involves cessation of the offending drug, administration of supplemental oxygen and treatment with methylene blue (1-2 mg/kg) if MetHb >30%, or for symptomatic patients with MetHb >20%. Vitamin C can be used as an alternative agent if there is a contraindication to methylene blue (for example, with patients simultaneously receiving serotonergic medications and/or those with G6PD deficiency).
PubMed: 35265556
DOI: 10.12890/2022_003191 -
Journal of Pain and Symptom Management Apr 2021Dysphagia is a common concern, especially in the last several days of life. Medications are often crushed for ease of administration for individuals with swallowing...
CONTEXT
Dysphagia is a common concern, especially in the last several days of life. Medications are often crushed for ease of administration for individuals with swallowing difficulty.
OBJECTIVES
To assess palatability of commonly used crushed over-the-counter (OTC) medications. A secondary objective is to evaluate pharmacist knowledge and opinions of crushing medications.
METHODS
Pharmacist participants sampled crushed OTC medications and completed presampling and postsampling surveys about crushing medications. Participants were excluded for current smoking or tobacco use, pregnancy, allergy to any study medication or applesauce, or potential drug-drug interaction with study medications. Eight OTC medications were crushed and mixed in applesauce: naproxen, fexofenadine, phenazopyridine, multivitamin, loperamide, famotidine, sennosides, and sennosides-docusate. Participants were blinded to medication samples and control (plain applesauce). Samples were rated from one (least palatable) to five (most palatable). Investigators recorded participants' comments, behaviors, and facial expressions during sampling.
RESULTS
Nineteen volunteers completed the study. Most participants rated three samples as not palatable (score of two or less): fexofenadine, 16 (84%); loperamide, 13 (68%); and sennosides-docusate, 16 (84%). All participants rated famotidine and sennosides palatable. The percentage of participants who would consider palatability in recommendations for crushing medications increased from 47% prestudy to 79% poststudy.
CONCLUSION
Palatability should be considered when recommending crushed medications. Survey responses indicate that pharmacists' opinions of crushed medications changed after this palatability experiment. Clinicians should evaluate the appropriateness of all medications when dysphagia is a concern and deprescribe medications when appropriate to reduce burden for patients and caregivers.
Topics: Deglutition Disorders; Humans; Surveys and Questionnaires
PubMed: 32976943
DOI: 10.1016/j.jpainsymman.2020.09.020 -
Female Pelvic Medicine & Reconstructive... 2019The aims of this study were to determine the efficacy of phenazopyridine when used intraoperatively to assess ureteral patency and to investigate factors that may...
OBJECTIVES
The aims of this study were to determine the efficacy of phenazopyridine when used intraoperatively to assess ureteral patency and to investigate factors that may influence its efficacy.
METHODS
This is a retrospective chart review performed at the Olive View-UCLA Medical Center, a Los Angeles County teaching hospital, from January 2014 through July 2016. Patients undergoing cystoscopy at the time of gynecologic surgery were identified via department case logs. All women receiving preoperative oral phenazopyridine were included. If ureteral flow was unable to be visualized with phenazopyridine alone, the medication was deemed ineffective, and sodium fluorescein was given intraoperatively. Patients were divided into a phenazopyridine effective or phenazopyridine ineffective group. Patient demographics, renal function, intraoperative fluids and urine output, estimated blood loss, timing and dose of medication administration, and complications were gathered from the chart and compared between groups using Fisher exact test, 2-sample t test, Wilcoxon test, and logistic regression for multivariable analysis. P < 0.05 was determined to be significant.
RESULTS
Preoperative phenazopyridine was effective in 190 (91.8%) of 207 patients. It was ineffective in 17 patients who then required intraoperative sodium fluorescein. The group in which phenazopyridine was effective was more likely to have been given a 200-mg (vs 100-mg) dose (P = 0.02) and had lower intraoperative urine output (median, 450 vs 800 mL; P = 0.002).
CONCLUSIONS
Preoperative oral phenazopyridine is effective in more than 90% of cases to detect during gynecologic surgery. A higher phenazopyridine dose and lower intraoperative urine output were associated with increased efficacy.
Topics: Administration, Oral; Adult; Aged; Coloring Agents; Cystoscopy; Female; Fluorescein; Gynecologic Surgical Procedures; Humans; Intraoperative Complications; Intraoperative Period; Middle Aged; Phenazopyridine; Preoperative Period; Retrospective Studies; Surgical Wound; Ureter; Urine
PubMed: 29300258
DOI: 10.1097/SPV.0000000000000540 -
European Urology Focus Jul 2023The rise in antimicrobial resistance means that alternative approaches for the treatment and prevention of urinary tract infection (UTIs) are required. (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
The rise in antimicrobial resistance means that alternative approaches for the treatment and prevention of urinary tract infection (UTIs) are required.
OBJECTIVE
To evaluate the safety and efficacy of a D-mannose-based dietary supplement (D-mannose, citric acid, prebiotic fibers, Astragalus, and dandelion; DAPAD complex) for the treatment of uncomplicated acute E. coli UTIs.
DESIGN, SETTING, AND PARTICIPANTS
This was a single-center, randomized, double-blind, placebo-controlled trial conducted from April 2021 to October 2021 in Rajalakshmi Hospital and Research Centre (Bangalore, India). The participants were nonmenopausal women with an acute uncomplicated E. coli UTI. UTI was diagnosed according to the presence of at least one urinary symptom and bacteriuria (>100 000 CFU/ml).
INTERVENTION
The DAPAD complex was administered twice a day for 5 d, with phenazopyridine and alkalizing agents as the standard of care (SOC). The control group received placebo with SOC.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS
Subjective (clinical resolution/response) and objective (midstream bacteriuria) outcomes were evaluated at the end of therapy (day 6) and at day 35 of follow-up. Adverse events were recorded. Categorical variables were analyzed using χ and Fisher's exact tests; a p value <0.05 was considered significant.
RESULTS AND LIMITATIONS
Seventy women were enrolled and equally randomized to the two groups. Clinical resolution was higher in the DAPAD group at 6 d (34.3% vs 0%; p < 0.0001) and 35 d from baseline (88.6% vs 20%, p < 0.0001). At day 35, no patients in the DAPAD group had moderate or severe symptoms, whereas 25.7% (nine/35) and 11.4% (four/35) of patients in the placebo group had moderate and severe symptoms, respectively. Bacteriological resolution was also higher in the DAPAD group at day 6 (85.7% vs 14.3%; p < 0.0001) and day 35 (100% vs 40%; p < 0.0001). Three mild adverse events (4.26%) unrelated to the investigated product were recorded, all of which were medically treated.
CONCLUSIONS
The DAPAD complex dietary supplement is effective and safe for treatment of acute uncomplicated E. coli UTIs.
PATIENT SUMMARY
Our results show that for nonmenopausal women with an uncomplicated Escherichia coli urinary tract infection, those treated with a dietary supplement (containing D-mannose, citric acid, prebiotic fibers, Astragalus, and dandelion) had a higher rate of clinical resolution or response than women who received a placebo.
Topics: Female; Humans; Mannose; Bacteriuria; Escherichia coli; Treatment Outcome; India; Urinary Tract Infections; Escherichia coli Infections; Dietary Supplements; Prebiotics
PubMed: 36621376
DOI: 10.1016/j.euf.2022.12.013 -
Cureus Jan 2023Methemoglobinemia is a condition caused by increased methemoglobin, a reduced form of hemoglobin, in the blood. This causes the molecules to bind oxygen more tightly and...
Methemoglobinemia is a condition caused by increased methemoglobin, a reduced form of hemoglobin, in the blood. This causes the molecules to bind oxygen more tightly and decreases their ability to release that oxygen to tissue. Most cases of methemoglobinemia are acquired and occur either in pediatric populations or in individuals with predisposing conditions. This report illustrates a case of an otherwise healthy 31-year-old patient presenting to the emergency department with cyanosis of the hands and mouth and an O2 saturation of 78% after taking increased doses of the over-the-counter medication phenazopyridine. A "chocolate-brown" color of her arterial blood, and increased methemoglobin levels of 20.2%, confirmed the diagnosis of methemoglobinemia. She was treated with both methylene blue and ascorbic acid, and her oxygen saturation and serum chemistry returned to normal levels within a few hours. The case highlights the importance of discussing the dosage of all over-the-counter medications with patients and recognizing the signs and symptoms of methemoglobinemia.
PubMed: 36788851
DOI: 10.7759/cureus.33715