Overactive bladder (OAB)

IC symptoms can mimic the symptoms of unresolved overactive bladder (OAB)

Consider IC in patients who present with

Urinary urgency and frequency (≥8 voids/day)²
Urgency associated with bladder pain²
Pelvic pain relieved upon urination²
Pain during sexual intercourse²
Symptoms unresponsive to anticholinergic therapy for presumed OAB³

Pain is a characteristic symptom of IC, but not OAB, and may help differentiate between the 2 conditions⁴

In patients with OAB, urgency is associated with fear of leakage, whereas in patients with IC, urgency is associated with bladder pain²

Findings suggest a high prevalence of IC in patients with OAB symptoms refractory to anticholinergic therapy³

A study showed that 25 of 47 patients with detrusor overactivity did not respond to therapy with 1 anticholinergic medication³
- 96% (24 of 25) of those patients were diagnosed with IC*

*Based on a positive Potassium Sensitivity Test (PST).

Patient with OAB-like symptoms

References:

Hanno PM. Bladder pain syndrome (interstitial cystitis) and related disorders. In: Wein AJ, Kavoussi LR, Novick AC, Partin AW, Peters CA, eds. Campbell-Walsh Urology. Vol 1. 10th ed. Philadelphia, PA: Saunders Elsevier Inc; 2012;357-401.
Rosenberg MT, Moldwin RM, Stanford EJ. Early diagnosis and management of interstitial cystitis: what nonspecialists should know. Women’s Health Gynecol Edition. 2005;5:108-115.
Minaglia S, Özel B, Bizhang R, Mishell DR Jr. Increased prevalence of interstitial cystitis in women with detrusor overactivity refractory to anticholinergic therapy. Urology. 2005;66:702-706.
Dell JR. Chronic pelvic pain of bladder origin: a focus on interstitial cystitis. Int J Fertil. 2003;48:154-162.

Urinary tract infection (UTI)

IC symptoms can mimic the symptoms of a urinary tract infection (UTI)

Consider IC in patients who present with

Urinary urgency and frequency (≥8 voids/day)²
Pelvic pain, usually relieved upon urination²
Pain during sexual intercourse²
A negative urine culture²
A history of recurrent UTIs unresponsive to antibiotic therapy¹

Millions of women seek treatment for UTI symptoms every year³

A study showed that 60% of patients (18 of 30) with IC were initially diagnosed with a UTI⁴

Patient with UTI-like symptoms

References:

Hanno PM. Bladder pain syndrome (interstitial cystitis) and related disorders. In: Wein AJ, Kavoussi LR, Novick AC, Partin AW, Peters CA, eds. Campbell-Walsh Urology. Vol 1. 10th ed. Philadelphia, PA: Saunders Elsevier Inc; 2012;357-401.
Rosenberg MT, Moldwin RM, Stanford EJ. Early diagnosis and management of interstitial cystitis: what nonspecialists should know. Women's Health Gynecol Edition. 2005;5:108-115.
Childs SJ, Egan RJ. Microbiology and epidemiology in recurrent lower urinary tract infections. Infect Urol. 1998;11:88-92.
Porru D, Politanò R, Gerardini M, et al. Different clinical presentation of interstitial cystitis syndrome. Int Urogynecol J Pelvic Floor Dysfunct. 2004;15(3):198-202.

Endometriosis

IC symptoms can mimic the symptoms of endometriosis

Consider IC in patients who present with

Pelvic pain and flares associated with menstruation^3,4
Pain during sexual intercourse^3,4
Symptoms unresponsive to endometriosis therapy^5,6

Endometriosis and IC may coexist

86% of patients (115 of 134) diagnosed with endometriosis at a pelvic pain referral center were also diagnosed with IC⁵
96% (58 of 60) of women with chronic pelvic pain were diagnosed with IC, and 80% (48 of 58) had biopsy-confirmed active endometriosis⁶
In those patients with unresolved endometriosis who had surgical therapy, IC should be considered if symptoms recur within the first 12 months⁷

Patient with endometriosis-like symptoms

References:

Hanno PM. Bladder pain syndrome (interstitial cystitis) and related disorders. In: Wein AJ, Kavoussi LR, Novick AC, Partin AW, Peters CA, eds. Campbell-Walsh Urology. Vol 1. 10th ed. Philadelphia, PA: Saunders Elsevier Inc; 2012;357-401.
Rosenberg MT, Moldwin RM, Stanford EJ. Early diagnosis and management of interstitial cystitis: what nonspecialists should know. Women’s Health Gynecol Edition. 2005;5:108-115.
Hanno PM, Burks DA, Clemens JQ, et al; Interstitial Cystitis Guidelines Panel of the American Urological Association Education and Research, Inc. AUA guideline for the diagnosis and treatment of interstitial cystitis/bladder pain syndrome. J Urol. 2011;185(6):2162-2170.
Parsons CL. Interstitial cystitis: epidemiology and clinical presentation. Clin Obstet Gynecol. 2002;45(1):242-249.
Chung MK, Chung RP, Gordon D. Interstitial cystitis and endometriosis in patients with chronic pelvic pain: the “Evil Twins” syndrome. JSLS. 2005;9:25-29.
Chung MK, Chung RP, Gordon D, Jennings C. The evil twins of chronic pelvic pain syndrome: endometriosis and interstitial cystitis. JSLS. 2002;6:311-314.
Butrick CW. Patients with chronic pelvic pain: endometriosis or interstitial cystitis/painful bladder syndrome? JSLS. 2007;11:182-189.

Chronic pelvic pain (CPP)

IC symptoms can mimic the symptoms of chronic pelvic pain (CPP)

Consider IC in patients who present with

Generalized pelvic pain for ≥6 months³
Pain during sexual intercourse²
Pain with bladder filling⁴
Urinary urgency²

Pelvic pain may be an indicator of IC

79% of patients (88 of 111) at a regional pelvic pain center who suffered from persistent pelvic pain (pre- and post-hysterectomy) were diagnosed with bladder dysfunction consistent with IC³
In a study of 45 women scheduled to undergo laparoscopy for CPP, 38% (17 of 45) were diagnosed with IC⁵

Patient with CPP-like symptoms

References:

Hanno PM. Bladder pain syndrome (interstitial cystitis) and related disorders. In: Wein AJ, Kavoussi LR, Novick AC, Partin AW, Peters CA, eds. Campbell-Walsh Urology. Vol 1. 10th ed. Philadelphia, PA: Saunders Elsevier Inc; 2012;357-401.
Rosenberg MT, Moldwin RM, Stanford EJ. Early diagnosis and management of interstitial cystitis: what nonspecialists should know. Women’s Health Gynecol Edition. 2005;5:108-115.
Chung MK. Interstitial cystitis in persistent posthysterectomy chronic pelvic pain. JSLS. 2004;8:329-333.
Sant GR, Nickel JC. Interstitial cystitis and chronic prostatitis: the same syndrome? In: Nickel JC, ed. Textbook of Prostatitis. Oxford, England: Isis Medical Media Ltd; 1999:169-176.
Clemons JL, Arya LA, Myers DL. Diagnosing interstitial cystitis in women with chronic pelvic pain. Obstet Gynecol. 2002;100:337-341.

Vulvodynia

IC symptoms can mimic the symptoms of vulvodynia

Consider IC in patients who present with^1,3

Chronic pelvic pain
Pain during and after sexual intercourse
Vulvar pain

IC and vulvodynia may have overlapping symptoms due to a common etiology¹

Patients presenting with vulvodynia may have underlying IC that is causing or contributing to their pain⁴
Vulvodynia and IC may occur concomitantly
- In a study of 46 women with IC or symptoms of vulvodynia (focal vulvitis), 24% had both conditions⁵

Patient with vulvodynia-like symptoms

References:

Hanno PM. Bladder pain syndrome (interstitial cystitis) and related disorders. In: Wein AJ, Kavoussi LR, Novick AC, Partin AW, Peters CA, eds. Campbell-Walsh Urology. Vol 1. 10th ed. Philadelphia, PA: Saunders Elsevier Inc; 2012;357-401.
Rosenberg MT, Moldwin RM, Stanford EJ. Early diagnosis and management of interstitial cystitis: what nonspecialists should know. Women’s Health Gynecol Edition. 2005;5:108-115.
Parsons CL, Stanford EF, Kahn, BS, et al. Tools for diagnosis and treatment. Female Patient. 2002;(May Suppl):S12-S17.
Siegel JF, Sand PK, Sasso K. Vulvodynia & pelvic pain? Think interstitial cystitis. Nurse Pract. 2008;33(10):40-45.
McCormack WM. Two urogenital sinus syndromes: interstitial cystitis and focal vulvitis. J Reprod Med. 1990;35:873-876.

Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS)

IC symptoms can mimic the symptoms of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS)

Consider IC in patients who present with^1,3

Voiding symptoms (urgency, frequency [≥8 voids/day], nocturia)²
Generalized pelvic pain²
Pain during sexual intercourse²
Pain with bladder filling³
Unresolved symptoms after empiric antibiotic therapy¹

Men presumed to have CP/CPPS who are unresponsive to antibiotic therapy may suffer from IC

In 3 separate retrospective studies, 58% to 90% of men with CP/CPPS had cystoscopic findings consistent with IC^4-6
- 58%, N=60; 60%, N=20; 90%, N=30

Patient with CP/CPPS-like symptoms

References:

Hanno PM. Bladder pain syndrome (interstitial cystitis) and related disorders. In: Wein AJ, Kavoussi LR, Novick AC, Partin AW, Peters CA, eds. Campbell-Walsh Urology. Vol 1. 10th ed. Philadelphia, PA: Saunders Elsevier Inc; 2012;357-401.
Rosenberg MT, Moldwin RM, Stanford EJ. Early diagnosis and management of interstitial cystitis: what nonspecialists should know. Women’s Health Gynecol Edition. 2005;5:108-115.
Sant GR, Nickel JC. Interstitial cystitis and chronic prostatitis: the same syndrome? In: Nickel JC, ed. Textbook of Prostatitis. Oxford, England: Isis Medical Media Ltd; 1999;169-176.
Berger RE, Miller JE, Rothman I, et al. Bladder petechiae after cystoscopy and hydrodistension in men diagnosed with prostate pain. J Urol. 1998;159:83-85.
Miller JL, Rothman I, Bavendam TG, Berger RE. Prostatodynia and interstitial cystitis: one and the same? Urology. 1995;45:587-590.
Sant GR, Kominski A. Interstitial cystitis in men is frequently misdiagnosed as prostatitis/prostatodynia. Bethesda, MD: National Institutes of Health. 1997 International Research Symposium on Interstitial Cystitis; October 1997.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

ELMIRON^® is contraindicated in patients with known hypersensitivity to the drug, structurally related compounds, or excipients.

WARNINGS

Retinal Pigmentary Changes: Pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of ELMIRON^® (see ADVERSE REACTIONS). Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use. While the etiology is unclear, cumulative dose appears to be a risk factor. Visual symptoms in the reported cases included difficulty reading, slow adjustment to low or reduced light environments, and blurred vision. The visual consequences of these pigmentary changes are not fully characterized. Caution should be used in patients with retinal pigment changes from other causes in which examination findings may confound the appropriate diagnosis, follow-up, and treatment. Detailed ophthalmologic history should be obtained in all patients prior to starting treatment with ELMIRON^®. If there is a family history of hereditary pattern dystrophy, genetic testing should be considered. For patients with preexisting ophthalmologic conditions, a comprehensive baseline retinal examination (including color fundoscopic photography, ocular coherence tomography (OCT), and autofluorescence imaging) is recommended prior to starting therapy. A baseline retinal examination (including OCT and autofluorescence imaging) is suggested for all patients within 6 months of initiating treatment and periodically while continuing treatment. If pigmentary changes in the retina develop, then risks and benefits of continuing treatment should be reevaluated, since these changes may be irreversible. Follow-up retinal examinations should be continued given that retinal and vision changes may progress even after cessation of treatment.

PRECAUTIONS

Anticoagulant Activity: ELMIRON^®is a weak anticoagulant which may increase bleeding. Rectal hemorrhage was reported as an adverse event in 6.3% of patients. Patients undergoing invasive procedures or having signs/symptoms of underlying coagulopathy or other increased risk of bleeding (due to other therapies such as coumarin anticoagulants, heparin, t-PA, streptokinase, high dose aspirin, or nonsteroidal anti-inflammatory drugs) should be evaluated for hemorrhage. Patients with diseases such as aneurysms, thrombocytopenia, hemophilia, gastrointestinal ulcerations, polyps, or diverticula should be carefully evaluated before starting ELMIRON^®.
Heparin-Induced Thrombocytopenia: Caution should be exercised when using ELMIRON^® in patients who have a history of heparin-induced thrombocytopenia.
Alopecia: In clinical trials of ELMIRON^®, 97% of the cases of alopecia reported were alopecia areata, limited to a single area on the scalp.
Hepatic Insufficiency: ELMIRON^® has not been studied in patients with hepatic insufficiency. Because there is evidence of hepatic contribution to the elimination of ELMIRON^®, hepatic impairment may have an impact on the pharmacokinetics of ELMIRON^®. Caution should be exercised when using ELMIRON^® in this patient population.
Information for Patients: Patients should take the drug as prescribed, in the dosage prescribed, and no more frequently than prescribed. Patients should be informed that changes in vision should be reported and evaluated. Retinal examinations including optical coherence tomography (OCT) and autofluorescence imaging are suggested for all patients within 6 months of starting ELMIRON^® and periodically during long-term treatment (see WARNINGS). Patients should be reminded that ELMIRON^® has a weak anticoagulant effect. This effect may increase bleeding times.
Pregnancy and Nursing Mothers: Adequate and well-controlled studies have not been performed in pregnant women. This drug should be used in pregnancy only if clearly needed. It is not known if ELMIRON^® is excreted in human milk. Caution should be exercised when ELMIRON^® is administered to a nursing woman.
Pediatric Use: Safety and effectiveness in pediatric patients below the age of 16 years have not been established.

MOST COMMON ADVERSE REACTIONS (frequency 1% to 4%)

Alopecia (4%), diarrhea (4%), nausea (4%), headache (3%), rash (3%), dyspepsia (2%), abdominal pain (2%), liver function abnormalities (1%), and dizziness (1%).

Please click here to see full Prescribing Information for ELMIRON^®.

cp-59277v2

Interstitial Cystitis (IC) May Look Like Other Conditions

Overactive bladder (OAB)

Urinary tract infection (UTI)

Endometriosis

Chronic pelvic pain (CPP)

Vulvodynia

Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS)

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

ELMIRON^® is indicated for the relief of bladder pain or discomfort associated with interstitial cystitis.

INDICATION