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

Overactive Bladder Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00441428
• Other study ID #: UDASOL-1520
• Status: Completed
• Phase: Phase 2
• First received: February 27, 2007
• Last updated: June 2, 2008
• Start date: February 2006

Study information

• Verified date: June 2008
• Source: University of L'Aquila
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Detrusor Underactivity
• Hypokinesia
• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• solifenacin

Locations

Country	Name	City	State
Italy	University of L'Aquila	L'Aquila	Abruzzo

Sponsors (1)

Lead Sponsor	Collaborator
University of L'Aquila

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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