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

This study has been completed.
Sponsor:
Information provided by:
University of L'Aquila
ClinicalTrials.gov Identifier:
NCT00441428
First received: February 27, 2007
Last updated: June 2, 2008
Last verified: June 2008
  Purpose

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 Intervention Phase
Overactive Bladder
Detrusor Underactivity
Drug: solifenacin
Phase 2

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by University of L'Aquila:

Primary Outcome Measures:
  • 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:
  • 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

Study Start Date: February 2006
Estimated Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00441428

Locations
Italy
University of L'Aquila
L'Aquila, Abruzzo, Italy, 67100
Sponsors and Collaborators
University of L'Aquila
Investigators
Principal Investigator: Piero Ronchi, M.D University of L'Aquila
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00441428     History of Changes
Other Study ID Numbers: UDASOL-1520
Study First Received: February 27, 2007
Last Updated: June 2, 2008
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Hypokinesia
Urinary Bladder, Overactive
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014