Safety And Efficacy Of Solifenacin In Men With Overactive Bladder (OAB) And Detrusor Underactivity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00441428
Recruitment Status : Completed
First Posted : February 28, 2007
Last Update Posted : June 4, 2008
Information provided by:
University of L'Aquila

Brief Summary:

Detrusor underactivity (DUA) in men is responsible for LUTS in a significant minority, the symptoms being indistinguishable from those seen in BOO. The International Continence Society (ICS) defines DUA as 'a detrusor contraction of inadequate magnitude and/or duration to effect complete bladder emptying in the absence of urethral obstruction. Whilst a reduced maximum urinary flow rate (Qmax) is indicative of voiding dysfunction, flow studies cannot distinguish between DUA and BOO, which are the two principal causes of low flow rates. DUA is diagnosed from a pressure-flow study (PFS)and is characterized by a low-pressure, poorly sustained, or wave-like detrusor contraction with an associated poor flow rate.

Overactive bladder (OAB) is the most common term currently used in clinical medicine to describe a complex of lower urinary tract symptoms (LUTS) with or without incontinence but most commonly consisting of urgency, frequency, nocturia, troublesome or incomplete emptying,and, occasionally, pain. With the exception of pain and incontinence, these symptoms are often found together; thus, the term LUTS has come to replace previous terms, such as urgency-frequency syndrome,urethral syndrome, and prostatism.

Drug treatment is frequently used as the initial management approach for LUTS in older men.Among men who desire treatment, general practice prescribing data have shown that antimuscarinics are not often given to elderly men. There is theoretical concern that the inhibitory effect of antimuscarinics on detrusor contraction could aggravate voiding difficulties or cause urinary retention in patients with BOO. There are virtually no data evaluating the safety and efficacy of solifenacin treatment in men with DUA and OAB.

Condition or disease Intervention/treatment
Overactive Bladder Detrusor Underactivity Drug: solifenacin

Study Type : Observational
Study Start Date : February 2006
Primary Completion Date : January 2007

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U.S. FDA Resources

Primary Outcome Measures :
  1. We estimated the safety of solifenacin treatment by measuring the changes to day 120 of voiding function. The following variables were assessed: BVE, BCI, BOOI, Qmax obtained during UDS, PVR

Secondary Outcome Measures :
  1. We estimated the efficacy of solifenacin treatment. For this purpose, the primary efficacy measure was change in the number of urge incontinence episodes per week. Secondary efficacy measures included patient perception of treatment

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men aged > 40 years were eligible if by 7-day bladder diary they had urinary frequency (8 or more micturitions per 24 hours) and urgency, with or without urgency incontinence (1 or more episodes per 24 hours) together with coexistence low detrusor contractility.

Exclusion Criteria:

  • Urinary tract infection,
  • Bladder stone, urogenital tumors,
  • Prostate surgery,
  • Use of indwelling catheter or self-catheterization program,
  • Medications that could affect the lower urinary tract function,
  • History of neurological disease,
  • Acute urinary retention or any condition for which antimuscarinic was contraindicated.
  • Antimuscarinic, antispasmodic, or electrostimulation within 1 month;
  • Any investigational drug within 2 months; or
  • A 5a-reductase inhibitor within 3 months of screening.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00441428

University of L'Aquila
L'Aquila, Abruzzo, Italy, 67100
Sponsors and Collaborators
University of L'Aquila
Principal Investigator: Piero Ronchi, M.D University of L'Aquila Identifier: NCT00441428     History of Changes
Other Study ID Numbers: UDASOL-1520
First Posted: February 28, 2007    Key Record Dates
Last Update Posted: June 4, 2008
Last Verified: June 2008

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Neurologic Manifestations
Nervous System Diseases
Solifenacin Succinate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents