The Myth: Elmiron(R) is your only treatment (or best) treatment option.
The Truth: Though many urologists prescribe Elmiron(R) to patients and ask them to wait 6-12 months to see if it works, there are many other treatment options that are recommended by the American Urological Association. At best, Elmiron(R) has been shown to benefit only 1 out of 3 patients; at worse, it has been shown to be no more effective than a placebo and causes significant side effects.
Myth Origin: Elmiron(R) remains the only oral medication approved by the FDA specifically for interstitial cystitis, having received approval in 1996. Because of this, many physicians prescribe this before trying other medications or treatment options. Instructions for using the drug say it may not have any effect for 6-12 months, so many times it's not apparent at all whether it is working or not.
“No single treatment has been found effective for the majority of patients, and the fact that acceptable symptom control may require trials of multiple therapeutic options (including combination therapy) before it is achieved.”
Debunking the Myth: Elmiron (Evidence Grade 'B') is recommended in the first line of medical interventions, but so are several other therapies, several with more evidence of effectiveness. Also recommended in this line of treatment are:
Pelvic Floor Physical Therapy (Evidence Grade 'A')
Pain Management
Oral Medications including Amitriptyline ('B'), Cimetidine ('B') and Hydroxyzine ('B')
Bladder Instillations including Lidocaine ('B') and Heparin ('C')
While these treatments and drugs haven't gone through the regulatory process to be FDA-approved specifically for interstitial cystitis, in many cases they have been shown to be significantly more effective than Elmiron(R). Many drugs are commonly and successfully used 'off-label' for other conditions (because it isn't worth the time and expense to the manufacturer to go through the entire FDA process again for a different condition than the one they were originally approved for).
The only other treatment to be FDA-approved for IC was DMSO bladder instillations - since then, we have realized that other types of instillations provide more benefit with fewer side effects, and DMSO is rarely used anymore.
The evidence for Elmiron(R) is also contradictory. Several studies, including the most recent and largest study (which was terminated due to lack of positive results), have found that it has no benefit over a placebo. Others have shown that it may benefit some patients, but only about 1 in 3 saw any significant improvement. Recent research is also showing disturbing long-term consequences of Elmiron(R) use, including ocular changes.
"Results of this study in a broad population of patients with symptoms consistent with interstitial cystitis revealed no treatment effect vs placebo for pentosan polysulfate sodium [Elmiron(R)] at the currently established dose or at a third of the daily dose." - Nickel et al, 2015
"In this study, overall improvement of greater than 25 percent was reported by 28 percent of the PPS-treated patients and by 13 percent of the placebo-treated patients" - Mulholland et al, 1990
It's also important to note from the research that 'high-dose' Elmiron(R) is not any more effective than the standard, or even a smaller, dose. Studies have shown that tripling the standard dose, from 300 mg to 900 mg, had no benefit for patients. In another study, 300 mg had the same effect as 100 mg of Elmiron(R) daily (which was no better than a placebo).
Impact of the Myth: Many patients spend months or years waiting for Elmiron(R) to work, because they have been told it is their only option or it is the first thing prescribed by their doctor. This may significantly delay starting more effective and proven treatments.
In truth, a combination of different therapies should be tried, particularly as we know that Elmiron(R) will only benefit about one-third of patients (if it's effective at all).
Read on to find out the truth about these myths, and feel free to join the online Facebook community Finding Pelvic Sanity for support and resources!
Additional Resources
Dr. Nicole Cozean is the founder of PelvicSanity physical therapy, Orange County's premier pelvic floor physical therapy clinic. Nicole was named the 2017 IC Physical Therapist of the Year, was the first PT to serve on the ICA Board of Directors, and is the author of the award-winning book The Interstitial Cystitis Solution (2016). She is an adjunct professor at her alma mater, Chapman University.