About OABOAB Symptoms and Coping

WHAT IS OVERACTIVE BLADDER (OAB)?

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SELF-ASSESSMENT TOOL

HEAR FROM OTHERS

Female patient waiting for restroom

About OAB

What are the symptoms of OAB?

Ever find yourself cutting activities short to deal with bladder symptoms? If so, you’re not alone. OAB is a real, chronic medical condition that may be caused by your bladder muscles suddenly contracting too frequently and too often, even when your bladder isn't full, creating an urgent feeling that you need to urinate.

Male patient waiting for restroom

What OAB is

The three key symptoms of OAB are:

Leakage episodes (Uncontrollable urine leaks)

Urgency (“Gotta-go” now even when the bladder isn't full)

Frequency (“Gotta-go” often — more than 8 times per day)

Male patient waiting for restroom

What OAB isn't

Something you always have to cope with on your own
A condition that always requires surgery for treatment
Treatable through lifestyle changes alone in some cases
Just a normal part of being a woman or man
Just a normal result of getting older

OAB is more common than you think — you’re not alone

Approximately 1 in 10 Americans are affected by bothersome overactive bladder symptoms.

That's about 33 million people.

Tired of just coping with OAB symptoms? These lifestyle changes may be a sign it's time to talk to your doctor:

Mapping out the closest bathrooms when traveling or leaving home
Packing extra underwear, pads, or clothes in case of an accident
Wearing panty liners, pads, or absorbent briefs daily

Restricting fluids, especially bladder irritants like caffeine
Carefully planning your commute or even changing travel plans
Limiting activities by exercising less or not at all

Try the 6-question OAB self-assessment tool before your next visit to the doctor

Complete the assessment and email it to yourself to receive a handy discussion guide that can help you start the conversation with your doctor.

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Hear from others

I noticed I was going to the bathroom a lot and had a sudden urge to go, like now.

Holly, GEMTESA Go-Getter

Holly, professional actor, is a real patient and GEMTESA Go-Getter who has been compensated for her time.

Individual results may vary.

Holly Robinson Peete is a patient taking GEMTESA®

Rodney Peete is a patient taking GEMTESA®

Robyn is a patient taking GEMTESA®

GET READY TO ASK YOUR DOCTOR ABOUT OAB

DISCOVER HOW GEMTESA CAN HELP

Female patient talking to female doctor

Female patient talking to female doctor

GEMTESA® is a prescription medicine used to treat the following symptoms due to a condition called overactive bladder (OAB) in adults, and in adult males taking medicine for benign prostatic hyperplasia (BPH): leakage episodes, urgency, and frequency.

IMPORTANT SAFETY INFORMATION & USE

Do not take GEMTESA if you are allergic to vibegron or any of the ingredients in GEMTESA.

Before you take GEMTESA, tell your doctor about all your medical conditions, including if you have liver problems; have kidney problems; have trouble emptying your bladder or you have a weak urine stream; take medicines that contain digoxin; are pregnant or plan to become pregnant (it is not known if GEMTESA will harm your unborn baby; talk to your doctor if you are pregnant or plan to become pregnant); are breastfeeding or plan to breastfeed (it is not known if GEMTESA passes into your breast milk; talk to your doctor about the best way to feed your baby if you take GEMTESA).

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

What are the possible side effects of GEMTESA?
GEMTESA may cause serious side effects including:

inability to empty your bladder (urinary retention). GEMTESA may increase your chances of not being able to empty your bladder, especially if you have bladder outlet obstruction or take other medicines for treatment of overactive bladder. Tell your doctor right away if you are unable to empty your bladder.
angioedema. GEMTESA may cause an allergic reaction with swelling of the lips, face, tongue, or throat, with or without difficulty breathing and may be life-threatening. Stop using GEMTESA and get emergency medical help right away if you have symptoms of angioedema or trouble breathing.

The most common side effects of GEMTESA include headache, urinary tract infection, nasal congestion, sore throat or runny nose, diarrhea, nausea and upper respiratory tract infection. These are not all the possible side effects of GEMTESA. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see full Prescribing Information and Patient Product Information for GEMTESA.

What is GEMTESA?

GEMTESA® is a prescription medicine used to treat the following symptoms due to a condition called overactive bladder in adults, and in adult males taking medicine for benign prostatic hyperplasia (BPH):

urge urinary incontinence: a strong need to urinate with leaking or wetting accidents
urgency: the need to urinate right away
frequency: urinating often

It is not known if GEMTESA is safe and effective in children.

IMPORTANT SAFETY INFORMATION & USE

Do not take GEMTESA if you are allergic to vibegron or any of the ingredients in GEMTESA.

Before you take GEMTESA, tell your doctor about all your medical conditions, including if you have liver problems; have kidney problems; have trouble emptying your bladder or you have a weak urine stream; take medicines that contain digoxin; are pregnant or plan to become pregnant (it is not known if GEMTESA will harm your unborn baby; talk to your doctor if you are pregnant or plan to become pregnant); are breastfeeding or plan to breastfeed (it is not known if GEMTESA passes into your breast milk; talk to your doctor about the best way to feed your baby if you take GEMTESA).

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

What are the possible side effects of GEMTESA?
GEMTESA may cause serious side effects including:

inability to empty your bladder (urinary retention). GEMTESA may increase your chances of not being able to empty your bladder, especially if you have bladder outlet obstruction or take other medicines for treatment of overactive bladder. Tell your doctor right away if you are unable to empty your bladder.
angioedema. GEMTESA may cause an allergic reaction with swelling of the lips, face, tongue, or throat, with or without difficulty breathing and may be life-threatening. Stop using GEMTESA and get emergency medical help right away if you have symptoms of angioedema or trouble breathing.

The most common side effects of GEMTESA include headache, urinary tract infection, nasal congestion, sore throat or runny nose, diarrhea, nausea and upper respiratory tract infection. These are not all the possible side effects of GEMTESA. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see full Prescribing Information and Patient Product Information for GEMTESA.

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

85%

FEMALE

MALE

15%

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.