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Three Part Question

In [patients suffering from a urinary tract infection], should [Pyridium] be [routinely administered to help relieve dysuria]?

Clinical Scenario

In the emergency department, you saw a young woman with severe symptoms of urinary urgency and burning. After your thorough evaluation, your diagnosis is a urinary tract infection. Before leaving, she asked you if you could give her something to relieve her symptoms while waiting the antibiotics to kick in ? You heard about phenazopyridine before but you wonder if it will really be helpful?

Search Strategy

The website clinicaltrials.gov was searched for an ongoing trial on the topic: 2 randomized control trials are completed on the same subject but the results are not yet available.

No bestbet was found on the topics

Medline, Embase and Cochrane were searched
MEDLINE (PUBMED) :
- ("Cystitis"[Mesh:NoExp] OR "Urinary Tract Infections"[Mesh] OR urinary tract infection*[tiab]) AND ("Phenazopyridine"[Mesh] OR phenazopyridine[tiab] OR pyridium[tiab] OR Urogesic OR urodol OR baridium OR pyridiate OR prodium OR azo-standard)

EMBASE :
- ((“urinary trac infection”/mj OR urinary tract infection) AND (“phenazopyridine”/mj OR phenazopyridine OR pyridium))

Search Outcome

Medline : 58 papers, 1 relevant after title/abstracts reading
Embase : 195 papers, 1 relevant after title/abstracts reading
Cochrane : There were no Cochrane review on the subject

References of related articles were screened and 1 relevant paper was found.

Total relevant papers about adults = 2

Relevant Paper(s)

Author, date and country	Patient group	Study type (level of evidence)	Outcomes	Key results	Study Weaknesses
Deepalatha. C. and Narayan Deshpande 2010 India	80 Adults (>18 years old) Male and female with uncomplicated urinary tract infection (UTI) and dysuria. Exclusion: pregnant woman, children, allergic and known hematologic disorders Intervention : Group 1 : treatment with phenazopyridine 200mg tid(PHZ) only (n=35) Group 2 : treatment with PHZ and antibiotics (n=25) Group 3 : treatment with cystone only (n=20) All treated for 48 hours	Randomized open label comparative study	Symptoms relief on a questionnaire of 4 questions (done at baseline, at 24hours and at 48 hours)	At 48 hours,complete symptoms relief of: - Burning pain: 73% in group 1 91% in group 2 and 53% in group 3. - Pain during voiding: 80%, 89%, 44% respectively - Frequency of urination: 66%, 83%, 51% respectively - Low back pain: 70%, 80%, 30%	Small sample study. Wrong comparison groups, it should be : group 1 : pyridium + antibiotics Group 2 : antibiotics only Wrong statistical measures Severe lack of details in the study.
			Measures of correlation for comparison of group 1 and 2, and group 2 and 3	p<0.05
Gilderman L, Hendry D, Patrick K 2001 United States	76 female, at least 12 years of age, in good health not pregnant, with an uncomplicated UTI Exclusion: prior use of analgesics or antibiotics or PHZ (aware or the orange urine discoloration), renal or liver disease, alcohol or drug abuse. Intervention: Group 1 : treatment with 2 tablets of PHZ 95mg (n=35) Group 2 : treatment with 2 tablets of placebo (n=41) No antibiotics or other analgesics for the 6 hours observation	Randomized double-blind, phase IV single dose outpatient study	Pain relief evaluated by a VAS on a scale of 0 to 10	The mean±sd pain relief on VAS was 3.0±0.8 in group 1 and 2.4±0.9 (p=0.0011)	Except for the title, authors do not confirm the double blind part. No explanation about why they chose an observation of 6 hours. Role of antibiotics not clearly explained. No information about a clinically significant pain relief on the VAS scale.
			Appreciation of the treatment (poor, fair, good, very good, excellent)	Appreciation of treatment: - Excellent: 31.4% in group 1 and 4.9% for placebo - Fair, good and very good: 68.6% vs 73.2% for placebo - Poor: 0% vs 22% for placebo
			Mean time of symptoms relief	3.2 vs 5.2 hours
			Any adverse events	none
			Complete relief of general discomfort	Complete relief of general discomfort occurred in 14/35 (40%) for group 1 and 3/41 (7.3%) for group 2 (p=0.0008)

Comment(s)

I did not find a study that answers directly the question. Although the FDA approves the indication of PHZ in dysuria for a maximal duration of 2 days in UTI, there is no strong evidence about their real effectiveness in UTI when used with antibiotics. A study evaluated the time to symptoms relief of UTI with ciprofloxaxin and found that 50% of patient had complete symptom relief at 6 hours, which is more than the study above. However, 2 studies evaluated the effect of PHZ on the bioavailability of antibiotics (ciprofloxacin and trimethoprim) when used concomitantly and no effect was found. To answer this specific question, two clinical trials on this subject are completed and not published but are sponsored by the pharmaceutical company which produces phenazopyridine.

Editor Comment

Abbreviations: UTI (urinary tract infection), PHZ (phenazopyridine), sd (standard deviation)

Clinical Bottom Line

There is no evidence to support the use of phenazopyridine in adjunct therapy for dysuria in urinary tract infection when treated with antibiotics.

Level of Evidence

Level 3 - Small numbers of small studies or great heterogeneity or very different population.

References

1. Dr Deepalatha. C DND A comparative study of phenazopyridine (pyridium) and cystone as short-term analgesic in uncomplicated urinary tract infection Int j Pharm Pharm Sci 2010;3(Suppl 2):224-6
2. Gilderman L HD, Patrick K. Evaluation of the efficacity of phenazopyridine hydrochloride as a urinary analgesic in women with urinary trac infection DA's Docket Management 2001. Protocol Number: 99-001-P