Study of 2 Doses of Solifenacin Succinate in Female Subjects With Overactive Bladder.
Condition: Detrusor Overactivity; Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: Placebo; solifenacin
Intervention description: Matching solifenacin placebo tablet; Tablet for oral administration
Intervention MeSH terms: Solifenacin Succinate
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 547.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Vesicare; Solifenacin; Detrusor Overactivity; Urinary Nerve Growth Factor; Overactive Bladder; Bladder wall thickness

Summary:

      The purpose is to see if solifenacin has any effect on bladder wall thickness and urine
      inflammatory marker measurements after 12 weeks of treatment.
    

Eligibility criteria:

        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