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



Status:Completed
Conditions:Overactive Bladder
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:10/14/2017
Start Date:January 2010
End Date:June 2011

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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.

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

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.

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
We found this trial at
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New York, NY
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Graz,
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West Reading, Pennsylvania 19611
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West Reading, PA
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