Please select the eligibility criteria that correspond to the clinical trial below.
Title: Urinary Urgency Outcomes Following Propiverine Treatment for an Overactive Bladder: PRopiverine Study on Overactive Bladder Including Urgency Data (PROUD)
Brief Summary: Overactive bladder (OAB) is defined as "urgency, with or without urge incontinence, usually with frequency and nocturia" in the absence of local pathological or endocrine factors. Urgency is defined as "the complaint of a sudden compelling desire to pass urine that is difficult to defer" and an abnormal sensation that is distinctly different from the normal physiologic feeling of 'urge to void' that occurs during typical bladder-filling cycles.

Because up to 50% of patients with OAB experience urgency without incontinence, and because urgency is the most bothersome symptom that drives behavioral adaptations such as frequent voiding because of the very fear of urgency, this is the cornerstone symptom of OAB that indicates the diagnosis of OAB.

Even though any effective treatment for OAB must reduce the patient's sense of urgency, its subjective nature makes it difficult to measure. Therefore, the clinical efficacy of OAB treatment was traditionally measured in terms of objective surrogate parameters instead of urgency itself: for example, change in urinary frequency, incontinent episodes, number of pads and urodynamically proven detrusor overactivity, which could be measured easily and quantifiably.

Recently, several methods that measure urgency have been developed and used in clinical practice. However, the analysis questioned the clinical significance of the results; a possible reason for this being the lack of data based on urinary urgency and the use of sensitive patient-driven criteria.

Propiverine hydrochloride (1-methyl-4-piperidyl diphenylpropoxyacetate hydrochloride) is a drug with combined antimuscarinic and calcium antagonistic actions. Previous trials on the clinical efficacy and safety of propiverine for treating patients with OAB have reported improvements in urinary frequency and incontinence, but not in urgency.

The aim of this study was to explore the efficacy of a daily regimen of propiverine at 20 mg (immediate release formulation) in improving urgency from baseline to 12 weeks of treatment in patients with OAB.


Options:
A: 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
B: Inclusion Criteria:

* age ≥ 18 years
* Overactive bladder for at least 3 months
* 3 day- voiding diary

  * average urinary frequency ≥ 10 voids/24hrs
  * urgency ≥ 2 episodes/24hrs
* "moderate to severe" in the Indevus Urgency Severity Scale (IUSS)

Exclusion Criteria:

* clinically significant stress urinary incontinence
* polyuria of more than 3000 ml/24 hrs
* severe hepatic or renal diseases
* contraindications to the use of antimuscarinic drugs
* genitourinary conditions that could cause OAB symptoms such as urinary tract infection, genitourinary malignancy or interstitial cystitis
* uninvestigated hematuria
* clinically significant bladder outlet obstruction
* clinically significant pelvic organ prolapse
* being on a bladder-training program or having been on electrostimulation therapy two weeks before randomization or intention to start
* unstable dosages of drugs with anticholinergic side effects
* any other investigational drug taken up to 2 months prior to randomization
* pregnancy or breastfeeding
C: Inclusion Criteria:

* 18 years or older patients suffering from OAB symptoms (urinary frequency of at least 8 micturitions per 24h, urinary urgency and at least 3 urge urinary incontinence episodes within 3 days), confirmed by a micturition bladder diary.

Exclusion Criteria:

* Other than urge incontinence
* History of prostate/uterine or other female organ cancer
D: Inclusion Criteria:

* Adult subjects with overactive bladder symptoms (subject-reported) for greater than or equal to 3 months prior to Screening/Enrollment visit.
* Reported at least an average of 1 UUI episode per 24 hours in the 3-day bladder diary prior to the Randomization/Baseline visit
* Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours as verified by the 3-day bladder diary prior to randomization/Baseline visit.

Exclusion Criteria:

* Subjects with any condition that would contraindicate their usage of fesoterodine including: hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excipients, urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh C), severe ulcerative colitis, and toxic megacolon.
* Subjects with clinically significant hepatic or renal disease or other significant unstable diseases.
* OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.
* Subjects with previous history of acute urinary retention requiring catheterization, or severe voiding difficulties in the judgment of the investigator, prior to baseline.

Answer: B