Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 3, Double-Blind, Randomized, Multi-center, Placebo-Controlled Sequential Dose Titration Study to Assess Efficacy, Safety and Population Pharmacokinetics of Solifenacin Succinate Suspension in Pediatric Subjects From 5 to Less Than 18 Years of Age With Overactive Bladder (OAB)
Brief Summary: Solifenacin succinate as a tablet formulation is already on the market for the treatment of symptoms of overactive bladder in adults. For the use in children and adolescent patients a new formulation of solifenacin has been developed.

This study investigated the effect and safety of solifenacin succinate liquid suspension compared to a non-active drug (placebo) over a 12-week period. The 2 weeks prior to the double blind period was a single-blind placebo run-in period in combination with behavioral urotherapy (Non-interventional diary assisted urotherapy consisting of overactive bladder (OAB) information, awareness, instruction, life-style advice and documentation of voiding habits and symptoms for OAB), followed by a 12 week daily treatment period. The study also investigated how well solifenacin succinate suspension is taken-up by the body and how long it stays in the body during this time.


Options:
A: Inclusion Criteria:

* voiding frequency 8 or above per day
* at least one incontinence episode per day
* age between 5-10 years
* body weight between 17 and 45 kg

Exclusion Criteria:

* normal age expected bladder capacity
* PVR more than 10 ml
* dysfunctional voiding
* neurogenic disorders
* UTI, constipation
B: Main Inclusion Criteria:

* Written Informed Consent has been obtained
* OAB (symptoms of urgency) according to International Children's Continence Society (ICCS) criteria
* Daytime incontinence with at least 4 or more episodes of incontinence confirmed by 7 day participant diary

Main Exclusion Criteria:

* Daily voiding frequency less than 5
* Extraordinary daytime urinary frequency according to the International Children's Continence Society (ICCS) definition
* Uroflow indicative of pathology other than OAB
* Maximum voided volume (morning volume excluded) \> expected bladder capacity for age \[(age +1) x 30\] in ml or a maximum voided volume (morning volume excluded) above 390 ml
* Post Void Residual (PVR) \> 20 ml
* Monosymptomatic enuresis
* Polyuria defined as \> 75 ml/kg/b.w./24 hours
* Dysfunctional voiding
* Congenital anomalies affecting lower urinary tract function
* Current constipation
* Current Urinary Tract Infection (UTI)
* Catheterization within 2 weeks prior to screening
C: Inclusion Criteria:

* Daytime urinary incontinence with at least 1 episode of at least 1 ml per week
* Incontinence refractory to treatment
* Informed consent

Exclusion Criteria:

* Severe diseases of the kidneys or urinary tract besides OAB
D: Inclusion Criteria:

Urologic Inclusion Criteria:

* Primary or secondary daytime urinary incontinence, persistent over 12 months of medical treatment
* An abnormal 3 day voiding diary compiled over a 3 week voiding period completed after 12 months of medical treatment
* Normal bladder ultrasound (if bladder ultrasound shows more than minimal bladder thickening \[\>3.0mm at 50% filling of expected capacity or less\] then a voiding cystourethrogram \[VCUG\] will be required to rule out bladder outlet obstruction)
* Abnormal urodynamic testing

Radiologic Inclusion Criteria:

* Normal position conus medullaris
* Any size filum terminale
* Any amount of fat in the filum terminale
* Terminal syringomyelia of less than one bony level is acceptable
* Lumbar bifid spinal lamina is acceptable

Exclusion Criteria:

* Patients with evidence of significant, progressive, lower extremity motor or sensory deficits, with evidence of progression over the previous 6 months
* The presence of cutaneous markings on the back, in the absence of confirmatory magnetic resonance imaging (MRI) findings of a specific spinal dysraphism does not exclude the patient from participation

Answer: B