Study of 2 Doses of Solifenacin Succinate in Female Subjects With Overactive Bladder. (SHRINK)

Astellas

Status and phase: Completed; Phase 4

Conditions: Detrusor Overactivity; Overactive Bladder

Treatments: Drug: solifenacin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01093534

2008-005215-17 (EudraCT Number)

905-EC-007

Details and patient eligibility

About

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

Full description

Participants satisfying all selection criteria at the end of the 2-week, single blind, placebo run-in period were randomized to receive 12-week double-blind treatment with solifenacin 5 mg or 10 mg once daily, or placebo.

Enrollment: 547 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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547 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received 2 placebo tablets once daily for 12 weeks.

Treatment:

Drug: Placebo

Solifenacin 5 mg

Experimental group

Description:

Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.

Treatment:

Drug: Placebo

Drug: solifenacin

Solifenacin 10 mg

Experimental group

Description:

Participants received two 5 mg solifenacin tablets once daily for 12 weeks.

Treatment:

Drug: solifenacin