A Study to Evaluate the Overall Effect of Solifenacin 5mg and 10mg on Bladder Wall Thickness and Urinary Nerve Growth Factor in Female Subjects With Overactive Bladder and a Diagnosis of Detrusor Overactivity - A Double-blind, Randomised, Placebo-controlled, Parallel Group, Multi-centre Study.

Phase 4

• Conditions: Overactive BladderDetrusor Overactivity; N32.8; Other specified disorders of bladder

• Registration Number: DRKS00003889
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2011-06-01
• Study Start: 2012-04-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 547

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

Study & Design

• Study Type: interventional
• Study Design: Not specified