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

NCT00441428 | Completed DMC

• 1 other identifier: UDASOL-1520
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder; Detrusor Underactivity

Outcome Measures

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

Interventions

solifenacin DRUG

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of L'Aquila: lead

Study Sites (1)

University of L'Aquila

L’Aquila, Abruzzo, 67100, Italy

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Bladder, Underactive

Interventions

Solifenacin Succinate

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Piero Ronchi, M.D

  University of L'Aquila

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 27, 2007
• First Posted: February 28, 2007
• Study Start: February 1, 2006
• Primary Completion: January 1, 2007
• Last Updated: June 4, 2008

Record last verified: 2008-06

Locations

IT (1)