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

June 2, 2008 updated by: University of L'Aquila

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Abruzzo
      • L'Aquila, Abruzzo, Italy, 67100
        • University of L'Aquila

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of L'Aquila

Investigators

  • Principal Investigator: Piero Ronchi, M.D, University of L'Aquila

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion

January 1, 2007

Study Registration Dates

First Submitted

February 27, 2007

First Submitted That Met QC Criteria

February 27, 2007

First Posted (ESTIMATE)

February 28, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

June 4, 2008

Last Update Submitted That Met QC Criteria

June 2, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDASOL-1520

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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