ClinicalTrials.gg
CompletedNCT00441428Updated Jun 4, 2008

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

An observational study in Overactive Bladder and Detrusor Underactivity, sponsored by University of L'Aquila. Completed at 1 site in Italy. Open to male participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2008-06-04.

Sponsored by University of L'Aquila · Observational

Study type
Observational
Ages
40 Years to 80 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Overactive Bladder
  • Detrusor Underactivity
03

In context

Urinary Bladder, Overactive

858 studies on the registry are indexed under Urinary Bladder, Overactive; 127 are open to participants now.

Browse Urinary Bladder, Overactive studies →

Lead sponsor

University of L'Aquila is the lead sponsor of 46 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 .
  • Antimuscarinic, antispasmodic, or electrostimulation within 1 month;
  • Any drug within 2 months; or
  • A 5a-reductase inhibitor within 3 months of screening.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Interventions

06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

1 site
  • University of L'Aquila
    L'Aquila, Abruzzo 67100, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00441428
Lead sponsor
University of L'Aquila
First posted
Feb 28, 2007
Start date
Feb 2006
Primary completion
Jan 2007
Last update
Jun 4, 2008

Study contacts

Piero Ronchi, M.D
principal investigator · University of L'Aquila

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.

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