Intervention: Solifenacin
Trial phase: Phase 4
ATC code: G04BD08 | G04CA53
SMILES: O=C(O[C@H]1CN2CCC1CC2)N1CCc2ccccc2[C@@H]1c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 36
Group description: Starting with 5mg of solifenacin by mouth daily with self-titration ("at home") up 10mg of solifenacin by mouth daily.
Eligibility criteria:
Inclusion Criteria:

Ambulatory male or female patients aged ≥18 years of age and able to use the toilet without difficulty.
Symptoms of OAB for > 3 months.
Written informed consent (IC) has been obtained.
Capable of filling out questionnaires.
Patients may be included if they were never exposed to anticholinergic agents specified for the treatment of OAB. Patients may also be included if they have previously been treated with FDA-approved anticholinergic agents for the treatment of OAB such as oxybutynin chloride (generic oxybutynin chloride, Ditropan XL®, Ditropan®, or OxytrolTM), tolterodine tartrate (Detrol® or Detrol LA®), or trospium chloride (Sanctura®, Sanctura XR®) and are no longer receiving such treatment for at least 14 days.
Patients undergoing non-medical treatments for OAB (pelvic floor exercises or any behavioral modification) must have had treatment initiated at least 4 weeks prior to enrollment and should not change regimen.
Normal urine analysis or sterile urine specimen (culture negative)

Exclusion Criteria:

Previous treatment with darifenacin
Duration of urgency with or without urge incontinence, usually accompanied with frequency and nocturia for <3 months
Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the Investigator
Evidence of a urinary tract infection (UTI); chronic inflammation such as interstitial cystitis and bladder stones
Clinically significant outflow obstruction (benign prostatic hyperplasia [BPH]) as determined by the Investigator.
Uncontrolled narrow angle glaucoma, urinary or gastric retention
All patients with severe renal or hepatic impairment will be excluded from the trial; dose increases to 10mg are not permitted for patients that have moderate hepatic impairment as evidenced by liver function testing.
Women of childbearing potential who are pregnant or intend to become pregnant during the study or who are sexually active and practicing an unreliable method of birth control, as judged by the Investigator, or will be lactating during the study.
A history of bladder cancer
Known or suspected hypersensitivity to solifenacin succinate, any of its components (lactose monohydrate, corn starch, hypromellose 2910, magnesium stearate, talc, polyethylene glycol 8000 and titanium dioxide with yellow ferric oxide [5mg tablet] or red ferric oxide [10 mg tablet]), or other anticholinergics.
Participation in any clinical trial (except patient registry trial) involving an investigational drug, within 30 days prior to enrollment
Patients with chronic severe constipation or history of diagnosed gastrointestinal disease obstruction.
Patients with hematuria.
Any clinical condition, which, in the opinion of the Investigator, would not allow safe completion of the study.