Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase IIb Randomized, Placebo- and Active Comparator (Tolterodine)-Controlled, 2-Part Clinical Study of the Efficacy and Safety of MK-4618 in Patients With Overactive Bladder A 52-week Extension to: A Phase IIb Randomized, Placebo- and Active Comparator (Tolterodine)-Controlled, 2-Part Clinical Study of the Efficacy and Safety of MK-4618 in Patients With Overactive Bladder
Brief Summary: This is a 2-part study to assess if vibegron (MK-4618) reduces the number of daily urinations more effectively than placebo in participants with overactive bladder (OAB). The primary hypothesis of the base study is that administration of vibegron demonstrates a dose-related reduction, compared with placebo, in average number of daily micturitions in participants with OAB after 8 weeks of treatment.


Options:
A: Inclusion Criteria:

* Female outpatients 18 years or older.
* Overactive bladder symptoms (subject-reported) for greater than or equal to 3 months.
* Currently sexually active with a male partner.

Exclusion Criteria:

* Diagnosed or suspected interstitial cystitis, uninvestigated hematuria, urogenital cancer, and interstitial or external radiation to the pelvis or external genitalia or clinically significant bladder outlet obstruction.
* Symptoms of incontinence being predominately stress urinary incontinence as determined by the investigator.
* Treated with antimuscarinic/ anticholinergic medication, for any reason including OAB, within the last 3 months or are expected to start therapy during the study treatment period.
* Any drug for urgency urinary incontinence (UUI) initiated within the past 3 months prior to Visit 1, with the exception of estrogen (topical or systemic) as long as treatment is not initiated within 4 weeks prior to Visit 1 (screening)
B: Inclusion Criteria:

* Symptoms of overactive bladder (OAB), including urinary frequency, urgency or urge incontinence, for greater than or equal to 3 months
* Urodynamic diagnosis of detrusor overactivity (DO)
* Either naïve to anti-muscarinic treatment (i.e. no prior history of use of anti-muscarinic agents) or 6-months anti-muscarinic treatment free (i.e. have had no anti-muscarinic treatment within 6 months) prior to the screening visit
* Bladder post-void residual volume of less than 30 ml
* Available to complete the study

Exclusion Criteria:

* History of stress urinary incontinence, urethral sphincter incompetence or neurogenic detrusor overactivity
* History, signs or symptoms suggestive of urinary tract infection (confirmed by positive urine analysis), obstruction or urogenital pro-lapse (greater than grade II)
* History of urinary tract operation within 6 months prior to screening
* Indwelling catheter or permanent catheter fitted
* History of pelvic area radiotherapy treatment
* Uncontrolled diabetes mellitus
* History of fibromyalgia
* Post-partum or breast-feeding within 3 months prior to screening visit
* Either pregnant or intends to become pregnant during the study or sexually active, of childbearing potential and is unwilling to utilize a reliable method of birth control (note: reliable methods are contraceptive pills of combination type, hormonal implants or injectable contraceptives)
* Positive pre-study hepatitis B surface antigen, hepatitis C antibody or human immunodeficiency virus (HIV) result at time of screening
* History of drug and / or alcohol abuse at time of screening
* History of urinary retention, severe gastrointestinal obstruction (including paralytic ileus or intestinal atony or toxic megacolon or severe ulcerative colitis), myasthenia gravis, uncontrolled narrow angle glaucoma or shallow anterior chamber or deemed to be at risk for these conditions
* Undergoing hemodialysis or has severe renal impairment or moderate hepatic impairment or who are on treatment with a potent cytochrome p450 (CYP) 3A4 inhibitor, e.g. Ketoconazole
* Currently dosing with medication(s) intended to treat overactive bladder symptoms or has a history of non-drug treatment, such as electrical therapy, magnetic field stimulation, pelvic floor treatment or bladder training intended to treat overactive bladder symptoms within 6 months prior to screening, as described in the list of prohibited medications
* Currently receiving or has a history of treatment with alpha blockers, botulinum toxin (cosmetic use is acceptable), resiniferatoxin or pelvic floor muscle relaxants within 9 months prior to screening
* Participated in any clinical study less than or equal to 3 months prior to screening
C: Inclusion Criteria:

* Female 50 or older
* Diagnosis of OAB (ICS definition)
* English literacy
* Ability to swallow oral medication
* Cognitive ability to give consent

Exclusion Criteria:

* Dementia/Depression/Delirium
* Current anticholinergic use (requires 2 week washout period)
* Current cholinesterase
* Urinary or gastric retention
* Severe decreased gastrointestinal motility
* Uncontrolled narrow-angle glaucoma
* Myasthenia gravis
* Diagnosis fo renal impairment (creatinine clearance \<30 mL/min)
D: Inclusion Criteria:

* If participant is of reproductive potential, must agree to remain abstinent or use (or have his/her partner use) 2 acceptable methods of birth control within the projected duration of the study
* Clinical history of OAB for at least 3 months and meets either the OAB wet or OAB dry criteria
* Is able to read, understand and complete questionnaires and voiding diaries without assistance
* Is ambulatory and in good general physical and mental health
* No clinically significant electrocardiogram or laboratory abnormality

Exclusion Criteria:

* If female, is currently pregnant or breast-feeding, or expecting to conceive within the projected duration of the study
* Evidence of diabetes insipidus, uncontrolled hyperglycemia or uncontrolled hypercalcemia
* Allergy, intolerance, or history of a significant clinical or laboratory adverse experience associated with any of the active or inactive components of tolterodine ER or vibegron (MK-4618) formulation; or has a history or active diagnosis of any condition contraindicated in the tolterodine ER prescribing label
* Has lower urinary tract pathology that could be responsible for urgency, frequency, or incontinence
* History of injury, surgery, or neurodegenerative diseases (e.g., multiple sclerosis) that could affect the lower urinary tract or its nerve supply
* History of continual urine leakage
* Surgery to correct stress urinary incontinence or pelvic organ prolapse within 6 months
* Known history of elevated postvoid residual
* Bladder training or electrostimulation within 2 weeks or is planning to initiate either procedure during the study
* Active or recurrent (\>6 episodes per year) urinary tract infections
* Current hematuria
* Required use of an indwelling catheter or requires intermittent catheterization
* History of fecal incontinence

Answer: D