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

Primary Purpose

Overactive Bladder, Detrusor Underactivity

Status
Completed
Phase
Locations
Italy
Study Type
Observational
Intervention
solifenacin
Sponsored by
University of L'Aquila
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Overactive Bladder

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of L'Aquila

Outcomes

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

Full Information

First Posted
February 27, 2007
Last Updated
June 2, 2008
Sponsor
University of L'Aquila
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1. Study Identification

Unique Protocol Identification Number
NCT00441428
Brief Title
Safety And Efficacy Of Solifenacin In Men With Overactive Bladder (OAB) And Detrusor Underactivity
Study Type
Observational

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
January 2007 (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of L'Aquila

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder, Detrusor Underactivity

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
solifenacin
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piero Ronchi, M.D
Organizational Affiliation
University of L'Aquila
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of L'Aquila
City
L'Aquila
State/Province
Abruzzo
ZIP/Postal Code
67100
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

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