Unique to Women
The Treatment and Mistreatment of Chronic "Urgency and Frequency": Gathering Women’s Experiences About Interstitial Cystitis
by Kay Zakariasen and Jennifer R. Hill, MD
In 1970 I had a bladder infection, hardly a cause for alarm. My gynecologist cleared up the infection with antibiotics but sent me to a urologist just to be on the safe side. Little did I know that I had just embarked upon a course of pain, repeated treatments, and frustration that would last for the next three decades. Between 1970—1975, I saw three urologists, all of whom had the same opinion: my urethra was too narrow to empty efficiently (“urethral stenosis”), and I’d have more infections if I did not have my urethra dilated periodically. The doctors said that, with the dilations, I’d be fine, and I believed them. It never occurred to me that I needed to know how other patients had fared with this treatment before agreeing to it.
Over the next five years, I had 10 dilations, each followed by instillation of silver nitrate into my bladder and a course of antibiotics. After the first dilation, I experienced “urgency and frequency” about six months post-surgery. After the 10th dilation, chronic urgency and frequency set in: I felt like I had to urinate, urgently, every second, no matter how often I went to the bathroom. Painful gas and intestinal bloating also became chronic, along with overwhelming fatigue. I feared the treatment had been a terrible mistake.
I am one of millions of people who suffer from symptoms that include chronic urgency and frequency, bladder pain, and pelvic pain. For over a century there’s been no accepted definition or validated diagnostic marker for this combination of symptoms, and diagnostic names have changed along with theories about the symptoms’ cause.1 (Each urologist I saw used a different diagnostic name for my condition. Previously termed “Interstitial Cystitis” (IC), the diagnosis is now starting to be called “Painful Bladder Syndrome” (PBS). For simplicity, this article refers to chronic urgency and frequency (U&F) and Interstitial Cystitis (IC).
Regardless of the name used, the condition is a challenging disease complex for both doctors and patients. It affects as many as nine million Americans (90% of whom are women) and is thought to be incurable. Common surgical treatments include widening of the urethra (“dilation”); bladder distention (“hydrodistention”), in which the bladder is filled with water to a high pressure; and bladder instillation, in which chemicals are put into the bladder (including silver nitrate, oxychlorosene [Chlorpactin WCS-90], and the organic solvent dimethyl sulfoxide [DMSO]). Many of these treatments have been used for decades, with high success rates claimed in uncontrolled studies, despite the fact that they damage the urethra and/or bladder’s inner layer.2 I began to fear that my chronic symptoms were caused by the dilations, instillations of silver nitrate (a caustic), and antibiotics.
Effective Treatment or Cause of Symptoms?
In 1975, my husband and I moved to New York where, desperate for help, I consulted three prominent urologists. I was shocked to learn they didn’t perform dilations because they did not believe they benefited patients. At this point, I started reading medical literature about dilation and other surgeries to treat these symptoms. Literature on dilation begins in 1917 and comes from urologists at major medical centers across the US; surgically widening the urethra has long been standard urological practice for IC. (In fact, dilation is encouraged by health care systems like Medicare, which recently increased physicians’ fees for dilation by 181%.3)
Yet, both early and current research clearly lacks high-quality evidence. Studies touting the effectiveness of surgeries such as hydrodistention and instillations often fail to follow basic practices of good scientific research. Almost no published reports on IC are randomized, controlled clinical studies in which researchers and patients were “blinded” about the subjects’ conditions and treatment being tested to ensure objectivity.4 Most studies also failed to include control groups, which compare a group getting the treatment being investigated with a control group receiving only a placebo.6 When higher quality scientific studies have been done, they often fail to support the initial positive results.5 As a result, experts suggest that the reported high success rates for IC treatments should be reduced by 35% to factor in the placebo effect, and by as much as 50% to address spontaneous remission of the patient’s symptoms.7 It’s likely that many women, if informed about these low success rates, would decide not to have invasive treatments.
Among the medical journal articles, there was a smaller group of urologists who believed that invasive treatments were harmful and that non-invasive, more conservative treatments were more successful in treating the condition. (Two articles’ titles are telling: “The Rape of the Female Urethra,” and “Ineffectiveness of Treatment of Urethral Syndrome in Women.”8)
Success at Last
In 1981, I found a rare internist with a second specialty in preventive medicine who treated me for food sensitivities and intestinal candida. I gave up dairy, wheat, sugar, and about 130 other common foods. My U&F improved only slightly, but my chronic and painful gas, bloating, and fatigue disappeared. The diet wasn’t easy, but half my pain was gone. From 1975--2003, I searched the medical literature and saw over 30 specialists. I have felt as if I’m in medical school without the benefit of classes, just trying to figure out what happened to me. My new diet, an Ayurvedic doctor, and complementary and alternative medicine kept me functioning until I found a doctor who successfully treated my “incurable” U&F. This doctor initially limited my diet to a mere six foods; put me on L-Lysine, to treat a virus; further addressed the candida; and treated me for my Small Intestinal Bacterial Overgrowth (SIBO) and parasites.9 While my diet is still restricted, I now take no prescription drugs and my U&F is finally gone.
Going to the Source – The Patient Survey
My first contact with other IC/U&F sufferers came through the many letters I received in response to a 1983 Prevention magazine article about my experience.10 (One woman described the surgeries she’d had, saying: “I’ve been butchered.”) The letters made me want to learn more about what others had experienced and how they’d dealt with the condition. Only independent answers directly from patients, I thought, would indicate whether standard urological treatment had helped women or made their symptoms worse. Some women may also have found remedies that could be shared with others.
In 2003, after successful treatment, I was finally well enough to pursue a patient survey. At that time, I was fortunate to meet Dr. Elizabeth Kavaler, a urologist who supported my goals and didn’t understand why urologists kept doing procedures that were, in her words, “unsuccessful at best.” With her advice and encouragement, I wrote a survey and posted it on the Internet to reach as many patients as possible. The survey asks patients whether various tests and treatments improved their symptoms, made them worse, or had no effect. More than 1,300 patients have now completed the survey, and an analysis of some of the data was published in Urology.11 Most of the respondents said that the surgeries either worsened or had no effect on their symptoms. (See below for these results; the survey and article are available at: http://www.cystitispatientsurvey.com/.)
The survey also asked about information provided by doctors about suggested treatments, and we are analyzing this information. Despite the principle that patients should be the primary decision-makers regarding their own treatment and care, it is clear that many women are not given all of the information they need to make a truly informed decision. 12 Patients have a right to know -- for every treatment a doctor offers -- the nature of the procedure, the quality of evidence supporting it, its benefits and risks, and any alternatives to that treatment. Had I asked for, or been given, that information, I might have opted not to have the treatments and chosen a less invasive treatment. As it was, I had to learn from mistakes and the price was three decades of pain.
There’s a larger problem here as well, one that’s been called “the modern epidemic”: harm caused by the physician, or “iatrogenic harm”.13 Iatrogenic harm has been caused by physicians’ continued reliance on invasive surgery and bladder instillations to treat IC – a condition with no specific definition or diagnostic marker – while patients report that these invasive treatments are not beneficial for most of them. While dilation or other surgical interventions may work for some patients, the treatment has been applied to the broad population of IC sufferers, many of whom do not need it, as evidenced by the many patients for whom it had no positive effect.
From the survey’s first release, the NWHN has posted a letter of support on the site’s home page. I want to thank both the NWHN, and Our Bodies Ourselves for their support on behalf of myself and other patients with these symptoms. We are looking for volunteer statisticians to help analyze more data; if you are interested in helping, please contact firstname.lastname@example.org. If you’re interested in doing your own patient survey, we would be happy to help, as well.
Our Patient Survey on Treatment Outcomes
The goal of our survey was to gather patients’ perceptions of the effect on their IC symptoms of pharmaceutical therapy and seven specific surgical procedures. Seven hundred and fifty women with a diagnosis of IC completed the Internet-based survey about whether they perceived their condition to have improved, not been affected, or deteriorated as a result of these specific treatments.
The most commonly performed surgeries for the respondents were hydrodistention, (62%); bladder instillation, (40%); and urethral dilatation, (27%). Equal numbers of patients reported their condition to have improved and to have deteriorated as a result of these invasive procedures (25-30% for each). The percentage of patients reporting no effect as a result of the procedures ranged from 13-50%. Of these surgical interventions, bladder instillations had the best-perceived outcome, deemed beneficial 45% of the time, although about one-quarter of respondents either reported that the treatment worsened their condition (28%) or resulted in no perceived effect (27%).
Drug therapy had the best-reported outcomes of treatments included in the survey. Elmiron -- the only FDA-approved oral medication to treat IC currently on the market -- had one of the best outcomes. Over half (53%) of the woman reported an improvement of their symptoms from using Elmiron, while only 4% reported deterioration. But, 30% of the patients reported that Elmiron had had no effect on their symptoms.
A surprising finding was the number of women who reported benefiting from over-the-counter (OTC) medications. Forty percent of respondents had used Prelief, an OTC medication that neutralizes food acids such as those found in citrus fruits, tomatoes, vinegar, and wine. Of patients who took Prelief, 60% felt their symptoms improved, and 36% reported that it had no effect on their symptoms. Of all treatments, Prelief had the best tolerability and the greatest number of patients reporting improved symptoms.
While many patients are helped by current treatments, an equal number of patients perceive their condition to have deteriorated due to treatment. Women perceived the surgical procedures examined in the study to be less effective than drug therapy. Surgeries also had a higher likelihood of causing a perceived deterioration in the woman’s condition, compared to medication. We believe that surgery must be used with caution in IC patients and that medication should be considered the first-line treatment for this condition.
1. Other diagnostic names include: cystitis, urethritis, urethral syndrome, lower urinary tract syndrome, pelvic pain syndrome, overactive bladder, etc. See: Christmas TJ, “Historical Aspects of Interstitial Cystitis,” in Sant GR (ed.), Interstitial Cystitis, Philadelphia: Lippincott-Raven Publishers, 1997, p. 6. [back to text]
2. Author’s interview with Dr. Jennifer Hill on 10/08; and Lemack GE, Foster B, Zimmern PE, et al, “Urethral dilation in women: a questionnaire-based analysis of practice”, Urology 1999; 54(1):37; and Hanno, PM, “Painful Bladder Syndrome/Interstitial Cystitis and Related Disorders,” in Wein AJ (ed.), Campbell-Walsh Urology, 9th Edition, Philadelphia: Saunders, 2007, p. 345, 357. [back to text]
3. Lemack GE, Foster B, Zimmern PE, et al, “Urethral dilation in women: a questionnaire-based analysis of practice”, Urology 1999; 54(1): 37. [back to text]
4. Fall M, Oberpenning F, Peeker R, “Treatment of bladder pain syndrome/interstitial cystitis 2008: Can we make evidence-based decisions?” Eur Urol 2008; 54(1):65-75 and Lemack. [back to text]
5. Fall M, Oberpenning F, Peeker R. “Treatment of bladder pain syndrome/interstitial cystitis 2008: Can we make evidence-based decisions?” Eur Urol 2008; 54(1):65-75. [back to text]
6. Hanno PM, “Interstitial Cystitis and Related Disorders ,” in Walsh PC (ed.), Campbell’s Urology, 8th Edition, Philadelphia: Saunders, 2002, p. 650. [back to text]
7. Hanno, PM, “Painful Bladder Syndrome/Interstitial Cystitis and Related Disorders,” in Wein AJ (ed.), Campbell-Walsh Urology, 9th Edition, Philadelphia: Saunders, 2007, pp. 356-358. [back to text]
8. Pfau A, “The Rape of the Female Urethra”, Urology Digest 1972; 11; Zufall R, “Ineffectiveness of treatment of urethral syndrome in women”, Urology 1978; 12(3):337-9. [back to text]
9. Gregg CR and PP Toskes, “Enteric Bacterial Flora and Small Bowel Bacterial Overgrowth Syndrome”, in Sleisenger and Fordtran (eds), Gastrointestinal and Liver Disease: Pathophysiology, Diagnosis, Management, Vol. 2, 7th Edition, Philadelphia: Saunders, 2002, pp. 1783-93. [back to text]
10. Zakariasen K, “Cystitis: Getting Off the Treatment Treadmill”, Prevention 1983; April, pp. 104-109. [back to text]
11. . Jennifer R. Hill, Ginger Isom-Batz, Georgia Panagopoulos, Kay Zakariasen and Elizabeth Kavaler, “Patient Perceived Outcomes of Treatments Used for Interstitial Cystitis,” UROLOGY, 71 (1), 2008. [back to text]
12. Sharpe VA and AI Faden, Medical Harm: Historical, Conceptual and Ethical Dimensions of Iatrogenic Illness, Cambridge University Press, Cambridge, 1997, pp. 54, 68, 70. [back to text]
13. Sharpe and Faden; Hadler NM, Last Well Person: How to Stay Well Despite the Health-Care System, Montreal: McGill-Queen’s University Press, 2004; and Peterson M, Our Daily Meds: How the Pharmaceutical Companies Transformed Themselves into Slick Marketing Machines and Hooked the Nation on Drugs, New York: Sarah Crichton Books, 2008. [back to text]
Kay Zakariasen, MA, is working on a book about chronic urgency and frequency, medical harm, and making decisions about medical treatment. Jennifer R. Hill, MD is the chief resident in urology at Lenox Hill Hospital in New York. Upon completion of her residency in June 2009, she will be practicing in New York City.
The authors wish to thank Yelena Aronson and Mikahail Markov for website design and programming; Steve Davis for data exportation; and Robert Green for additional and on-going data analysis. They would also like to thank Dr. Jennifer Hill, Dr. Ginger Isom-Batz, Georgia Panagopoulos, PhD, and Dr. Elizabeth Kavaler, who wrote the Urology article, as well as the volunteers who designed the website and programmed the survey – Professor Yelena Aronson, Mikhail Markov, and NetVantage. In addition, Kay would like to thank those who provided emotional and moral support, including her husband, David Hanson, and her children, Rebecca Finnell, Maire Crowe, Jill Osborne of the Interstitial Cystitis Network, and other friends. Thank you also to the IC sufferers who have written to us and encouraged us and to the 1500 people who filled out the 20-page survey.
This article was adapted from an article originally published in the March/April 2009 edition of the Women's Health Activist, the newsletter of the National Women's Health Network (NWHN). Special thanks to NWHN for allowing us to repost the article.
9.11.13 update: For additional information on the problems with urological treatment for so-called IC/PBS, please see Kay Zakariasen’s open letter to all patients who have received a diagnosis of IC/PBS.
Written by: Kay Zakariasen, MA & Jennifer R. Hill, MD
Last revised: Sept 2013
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