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SUCCESSFUL MANAGEMENT OF OVERACTIVE BLADDER (OAB) IS CRITICAL IN THE LONG-TERM CARE (LTC) SETTING

Urinary incontinence (UI) may be a symptom of a medical condition called OAB and may affect about 70% of LTC residents in the US 1,2

  • From a survey* of 71 directors of nursing (DONs), of LTC residents who suffer from UI, 75% are either always or frequently incontinent3
  • According to the same survey, only ~15% of residents received any treatment for UI3
  • Up to 78% of women and up to 72% of men in LTC facilities live with UI, but OAB is not often diagnosed4†

*Based on a study of 71 DONs who completed a 30-minute online survey conducted from February 27, 2020 to May 11, 2020.3

†Cross-sectional retrospective analysis of 175,632 nursing facility residents from October 1, 2010 to September 30, 2012.4

Early identification and diagnosis may help residents affected by burdensome OAB symptoms3,5,6

Symptom recognition is a critical first step toward OAB care. As many residents suffer from cognitive decline, they may have difficulty reporting OAB symptoms.‡ Here's what to look for2,7,8:

icon-urgency

Urgency (the hallmark symptom)

Sudden, strong urge to urinate immediately

icon-leakage

Urge urinary incontinence (UUI)/leakage

Involuntary leakage episodes (which may require use of absorbent products)

icon-frequency

Frequency

Urinating 8+ times per day

Many of your residents with OAB may benefit from treatment10

The following considerations may help you identify a resident who may be
struggling with untreated OAB and could benefit from treatment:

  • check iconHas been diagnosed with OAB (ICD-10-CM code N32.81||)11
  • check iconConsistently expresses the need to urgently urinate2
  • check iconHas had a “triggering event” (such as a fall, UTI, or complaint regarding UI)12-14
  • check iconRated incontinent based on the MDS 3.0 assessment15¶
  • check iconHas been using or is scheduled to use absorbent products regularly16
  • check iconCurrently uses (or has previously used) an OAB medication that is not (or was not) achieving treatment goals2

||The ICD-10 code is the standard diagnostic tool for epidemiology, health management, and clinical purposes. Nothing in this document is intended to serve as reimbursement advice. The decision about which code to report must be made by the provider/physician considering the clinical facts, circumstances, and applicable coding rules.

MDS 3.0 is a resident assessment and care screening criteria for nursing homes.15

ICD=International Classification of Diseases; MDS=minimum data set; UTI=urinary tract infection.

Schedule a visit with a GEMTESA representative to learn more about how GEMTESA (vibegron) may help in the LTC setting

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LTC Access & Resources
 

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any components of GEMTESA. Hypersensitivity reactions, such as angioedema, have occurred.

WARNINGS AND PRECAUTIONS

Urinary Retention

Urinary retention has been reported in patients taking GEMTESA. The risk of urinary retention may be increased in patients with bladder outlet obstruction and also in patients taking muscarinic antagonist medications for the treatment of OAB. Monitor patients for signs and symptoms of urinary retention, particularly in patients with bladder outlet obstruction and patients taking muscarinic antagonist medications for the treatment of OAB. Discontinue GEMTESA in patients who develop urinary retention.

Angioedema

Angioedema of the face and/or larynx has been reported with GEMTESA. Angioedema has been reported to occur hours after the first dose or after multiple doses. Angioedema, associated with upper airway swelling, may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, immediately discontinue GEMTESA and provide appropriate therapy and/or measures necessary to ensure a patent airway.

ADVERSE REACTIONS

Most common adverse reactions (≥2%) reported with GEMTESA were headache, urinary tract infection, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection.

 

INDICATIONS AND USAGE

GEMTESA® is a beta-3 adrenergic agonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any components of GEMTESA. Hypersensitivity reactions, such as angioedema, have occurred.

WARNINGS AND PRECAUTIONS

Urinary Retention

Urinary retention has been reported in patients taking GEMTESA. The risk of urinary retention may be increased in patients with bladder outlet obstruction and also in patients taking muscarinic antagonist medications for the treatment of OAB. Monitor patients for signs and symptoms of urinary retention, particularly in patients with bladder outlet obstruction and patients taking muscarinic antagonist medications for the treatment of OAB. Discontinue GEMTESA in patients who develop urinary retention.

Angioedema

Angioedema of the face and/or larynx has been reported with GEMTESA. Angioedema has been reported to occur hours after the first dose or after multiple doses. Angioedema, associated with upper airway swelling, may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, immediately discontinue GEMTESA and provide appropriate therapy and/or measures necessary to ensure a patent airway.

ADVERSE REACTIONS

Most common adverse reactions (≥2%) reported with GEMTESA were headache, urinary tract infection, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection.

Please see full Prescribing Information.

References: 1. McDaniel C, Ratnani I, Fatima S, Abid MH, Surani S. Urinary incontinence in older adults takes collaborative nursing efforts to improve. Cureus. 2020;12(7):e9161. doi:10.7759/cureus.9161 2. Gormley EA, Lightner DJ, Burgio KL, et al. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline. American Urological Association/Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction; 2019. Accessed July 20, 2021. https://www.auanet.org//guidelines-and-quality/guidelines/overactive-bladder-(oab)-guideline 3. Stefanacci RG, Yeaw J, Shah D, et al. Impact of urinary incontinence related to overactive bladder on long-term care residents and facilities: a perspective from directors of nursing. J Gerontol Nurs. 2022;48(7):38-46. doi:10.3928/00989134-20220606-06 4. Zarowitz BJ, Allen C, O'Shea T, Tangalos E, Berner T, Ouslander JG. Clinical burden and nonpharmacologic management of nursing facility residents with overactive bladder and/or urinary incontinence. Consult Pharm. 2015;30(9):533-542. doi:10.4140/TCP.n.2015.533 5. Lukacz ES, Sampselle C, Gray M, et al. A healthy bladder: a consensus statement. Int J Clin Pract. 2011;65(10):1026-1036. doi:10.1111/j.1742-1241.2011.02763.x 6. Aharony L, De Cock J, Nuotio MS, et al. Consensus document on the detection and diagnosis of urinary incontinence in older people. European Geriatric Medicine. 2017;8(3):202-209. doi.org/10.1016/j.eurger.2017.03.012 7. Zimmerman S, Sloane PD, Reed D. Dementia prevalence and care in assisted living. Health Aff (Millwood). 2014;33(4):658-666. doi:10.1377/hlthaff.2013.1255 8. Edmondson SD, Zhu C, Kar NF, et al. Discovery of vibegron: a potent and selective β3 adrenergic receptor agonist for the treatment of overactive bladder. J Med Chem. 2016;59(2):609-623. doi:10.1021/acs.jmedchem.5b01372 9. Data on file. Sumitomo Pharma America, Inc. 10. Willis-Gray MG, Dieter AA, Geller EJ. Evaluation and management of overactive bladder: strategies for optimizing care. Res Rep Urol. 2016;8:113-122. doi:10.2147/RRU.S93636 11. ICD-10 Index. Accessed February 11, 2021. https://icdlist.com/icd-10/index/other-diseases-of-the-urinary-system-n30-n39 12. Jayadevappa R, Chhatre S, Newman DK, Schwartz JS, Wein AJ. Association between overactive bladder treatment and falls among older adults. Neurourol Urodyn. 2018;37(8):2688-2694. doi:10.1002/nau.23719 13. Szabo SM, Gooch KL, Walker DR, Johnston KM, Wagg AS. The association between overactive bladder and falls and fractures: a systematic review. Adv Ther. 2018;35(11):1831-1841. doi:10.1007/s12325-018-0796-8 14. Perk S, Wielage RC, Campbell NL, et al. Estimated budget impact of increased use of mirabegron, a novel treatment for overactive bladder. J Manag Care Spec Pharm. 2016;22(9):1072-1084. doi:10.18553/jmcp.2016.22.9.1072 15. Department of Health and Human Services (DHHS), Centers for Medicare & Medicaid Services (CMS). MDS 3.0 Frequency Report. Accessed January 29, 2021. https://www.cms.gov/Research-Statistics-Data-and-Systems/Computer-Data-and-Systems/Minimum-Data-Set-3-0-Public-Reports 16. Freeman R, Foley S, Rosa Arias J, et al. Mirabegron improves quality-of-life, treatment satisfaction, and persistence in patients with overactive bladder: a multi-center, non-interventional, real-world, 12-month study. Curr Med Res Opin. 2018;34(5):785-793. doi:10.1080/03007995.2017.1419170

You are encouraged to report side effects and product complaints associated with GEMTESA by calling 1-833-876-8268.

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