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OAB in long-term care

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,

62%

are either always or frequently incontinent³

According to the same survey,

only

~15%

of residents received any treatment for UI³

Up to

78% & 72%

of women

of men

in LTC facilities live with UI, but OAB is not often diagnosed^4†

Early identification and diagnosis may help residents affected by burdensome OAB symptoms^2,5

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 for^3,6-8:

Urgency (the hallmark symptom)

Sudden, strong urge to urinate immediately

Urge urinary incontinence (UUI)/leakage

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

Frequency

Urinating 8+ times per day

Only 7% of patients (n=10,911) with OAB are diagnosed and treated in the LTC setting^9‡

^* 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, 2012.¹⁰

^‡ From an IQVIA database reporting baseline characteristics of 159,785 LTC patients with OAB.⁹

UI=involuntary leakage of urine; LTC=long-term care; OAB=overactive bladder.

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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.
overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH).

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.
overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH).

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 or 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:

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
Cameron AP, Chung DE, Dielubanza EJ, et al. The AUA/SUFU guideline on the diagnosis and treatment of idiopathic overactive bladder. J Urol. Published online April 23, 2024. doi:10.1097/JU.0000000000003985. https://www.auajournals.org/doi/10.1097/JU.0000000000003985
Stefanacci RG, Yeaw J, Shah D, Newman DK, Kincaid A, Mudd PN Jr. 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
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
Aharony L, De Cock J, Nuotio MS, et al; Task & Finish Working Group on Urinary Incontinence, European Union Geriatric Medicine Society (EUGMS). Consensus document on the detection and diagnosis of urinary incontinence in older people. Eur Geriatr Med. 2017;8(3):202-209. doi.org/10.1016/j.eurger.2017.03.012
Egan KB. The epidemiology of benign prostatic hyperplasia associated with lower urinary tract symptoms prevalence and incidence rates. Urol Clin North Am. 2016;43(3):289·-297.doi:10.1016/j.ucl.2016.04.001
D'Ancona C, Haylen B, Oelke M, et al, and the Standardisation Steering Committee ICS and the ICS Working Group on Terminology for Male Lower Urinary Tract and Pelvic Floor Symptoms and Dysfunction. The International Continence Society (ICS) report on the terminology for adult male lower urinary tract and pelvic floor symptoms and dysfunction. Neurourol Urodyn. 2019;38(2):433-477. doi:10.1002/nau.23897
Burnett AL, Walker DR, Feng Q, et al. Undertreatment of overactive bladder among men with lower urinary tract symptoms in the United States: a retrospective observational study. Neurourol Urodyn. 2020;39(5):1378-1386. doi:10.1002/nau.24348
Data on file. Sumitomo Pharma America, Inc.
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

STUDIED IN MORE THAN 1500 PATIENTS WITH OAB^1,2

12-week double-blind treatment period²

12 week double blind treatment period, Diagram

12 week double blind treatment period, Diagram

50.6% OF PATIENTS ENROLLED HAD HYPERTENSION AT BASELINE³

A 12-week, Phase 3, randomized, double-blind, placebo- and active-controlled multicenter study to evaluate the safety and efficacy of GEMTESA in 1500+ patients with symptoms of OAB.^1,2

12-week patient demographics^1-3

60

Years Old
Mean Age

Female

FEMALE

85%

FEMALE

MALE

15%

male

MALE

Treatment naïve or had prior ACh or β₃-agonist use in 12 months before study

77% OAB WET*

23% OAB DRY*

Symptoms of OAB ≥3 months with average ≥8 micturitions/day and ≥1 UUI/day, or average ≥8 micturitions/day and average ≥3 urgency episodes/day^2†

* OAB wet=average of ≥1 urge urinary incontinence episode per day; OAB dry=average of ≥3 urgency episodes and average of <1 urge urinary incontinence episode per day.²

^† UUI was defined as leakage of urine of any amount because the patient felt an urge or need to urinate immediately.¹

GEMTESA met efficacy endpoints^1,2

12-week study efficacy endpoints

Co-primary endpoints

CFB in average daily number of micturitions and urge urinary incontinence episodes at Week 12

Key secondary endpoints

CFB in average daily number of urgency episodes at Week 12
Percent of OAB-wet patients at Week 12 with ≥75% reduction in total number of urge urinary incontinence episodes in 24 hours*
Percent of all OAB patients at Week 12 with 50% reduction in total number of urgency episodes per 24 hours*

Efficacy analyses were performed using the FAS, except for incontinence episode endpoints, which used the FAS-I.²

* Data were based on unadjusted values for a supportive outcome measure that was a prescribed secondary endpoint in the pivotal EMPOWUR trial.²
ACh=anticholinergic; CFB=change from baseline; FAS=full analysis set; FAS-I=full analysis set for incontinence; OAB=overactive bladder; UUI=urge urinary incontinence.

References:

GEMTESA. Prescribing Information. Marlborough, MA; Sumitomo Pharma America; 2025.
Staskin D, Frankel J, Varano S, Shortino D, Jankowich R, Mudd PN Jr. International phase III, randomized, double-blind, placebo and active controlled study to evaluate the safety and efficacy of vibegron in patients with symptoms of overactive bladder: EMPOWUR. J Urol. 2020;204(2):316-324. doi:10.1097/JU.0000000000000807
Data on file. Sumitomo Pharma America, Inc.