Clinical trial NCT00282932: Detrol LA In Men With Overactive Bladder.
Official title: A Randomized, Double Blind, Placebo Controlled Detrol LA "Add-On" To Alpha-Blocker Study In Men With Persistent Overactive Bladder Symptoms Of Urinary Frequency And Urgency With/Without Urgency Incontinence After Previous Monotherapy With Alpha Blocker.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Overactive Bladder (OAB)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-01-27
Enrollment: 600
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An interventional active/placebo double blinded parallel randomized controlled study in which at 12 weeks of treatment, the primary endpoint of patient perception of bladder condition is measured along with associated safety and other secondary endpoints like bladder diary endpoints, quality of life and patient treatment satisfaction.

Patients included in the study must have symptoms of OAB (frequency of at least 8 per day and Urgency of at least 1 episode per day confirmed by bladder diary).

Patients are not eligible to enroll in the study if they have/had significant hepatic or renal disease, history of radiation treatment.


Eligibility criteria: Inclusion Criteria:

* Symptoms of OAB (frequency more than 8 per day and Urgency more than 1 episode per day confirmed by bladder diary)

Exclusion Criteria:

* Significant hepatic or renal disease, history of radiation treatment

Primary outcomes:
measure: Patient Perception of Bladder Condition at 12 weeks of treatment
Secondary outcomes:
measure: 1)To evaluate the additional benefit of 'Add-On' tolterodine L-tartrate ER (Detrol LA?), vs. placebo, to alpha-blocker therapy in men with persistent OAB symptoms of urinary frequency and urgency with/without urgency incontinence: a)On OAB symptoms as
measure: assessed by 5-day voiding bladder diaries including Urinary Sensation Scale, b)On symptoms as assessed by the International Prostate Symptom Score (IPSS), c)On patient perception of treatment benefit as assessed by the Patient Perception of Treatment
measure: Benefit Questionnaire (PPTB) , d)On patient perception of bladder condition as assessed by the change in the PPBC after 4 weeks of treatment, e)On bothersome quality of life (QoL) symptoms as assessed by the Overactive Bladder Questionnaire (OAB-q),
measure: f)On sexual QoL as assessed by the ICIQ-MLUTSsex Questionnaire , g)On patient satisfaction with medication as assessed by the Overactive Bladder Treatment Satisfaction Questionnaires (OAB-s), h)On nocturia bothersome measure as assessed by the Nocturia
measure: Quality-of-Life Questionnaire, 2)To evaluate the safety and tolerability of 'Add-On' tolterodine L-tartrate ER (Detrol LA?), vs. placebo, to alpha-blocker therapy in men with persistent OAB symptoms of urinary frequency and urgency with/without urgency
measure: incontinence.
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Pfizer Investigational Site
state: California
city: La Mesa
country: United States
facility: Pfizer Investigational Site
state: California
city: Aurora
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Iowa City
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: Shreveport
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Watertown
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Westampton
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: State College
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Surrey
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Victoria
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Kingston
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Oakville
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Pointe-Claire
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Aalborg
country: Denmark
facility: Pfizer Investigational Site
city: Herlev
country: Denmark
facility: Pfizer Investigational Site
city: Nykobing Falster
country: Denmark
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Duisburg
country: Germany
facility: Pfizer Investigational Site
city: Frankfurt
country: Germany
facility: Pfizer Investigational Site
city: Muelheim A.d. Ruhr
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Rosenheim
country: Germany
facility: Pfizer Investigational Site
city: Starnberg
country: Germany
facility: Pfizer Investigational Site
city: Latina
country: Italy
facility: Pfizer Investigational Site
city: Padova
country: Italy
facility: Pfizer Investigational Site
city: Bucheon-si
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Gyunggi-do
city: Busan
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Guadalajara
country: Mexico
facility: Pfizer Investigational Site
state: Jalisco
city: Zapopan
country: Mexico
facility: Pfizer Investigational Site
state: Jalisco
city: Tlalpan
country: Mexico
facility: Pfizer Investigational Site
state: México DF
city: Durango
country: Mexico
facility: Pfizer Investigational Site
city: Durango
country: Mexico
facility: Pfizer Investigational Site
city: Bodø
country: Norway
facility: Pfizer Investigational Site
city: Moelv
country: Norway
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Kosice
country: Slovakia
facility: Pfizer Investigational Site
city: Malacky
country: Slovakia
facility: Pfizer Investigational Site
city: Martin
country: Slovakia
facility: Pfizer Investigational Site
city: Skalica
country: Slovakia
facility: Pfizer Investigational Site
city: Bloemfontein
country: South Africa
facility: Pfizer Investigational Site
state: Free State
city: Bloemfontein
country: South Africa
facility: Pfizer Investigational Site
state: Free State
city: Parktown
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng Province
city: Durban
country: South Africa
facility: Pfizer Investigational Site
state: Kwa Zulu Natal
city: Pietermaritzburg
country: South Africa
facility: Pfizer Investigational Site
state: Kwa Zulu Natal
city: Cape Town
country: South Africa
facility: Pfizer Investigational Site
city: A Coruna
country: Spain
facility: Pfizer Investigational Site
state: A Coruña
city: Palma de Mallorca
country: Spain
facility: Pfizer Investigational Site
state: Islas Baleares
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Granada
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Boras
country: Sweden
facility: Pfizer Investigational Site
city: Huskvarna
country: Sweden
facility: Pfizer Investigational Site
city: Lund
country: Sweden
facility: Pfizer Investigational Site
city: Skovde
country: Sweden
facility: Pfizer Investigational Site
city: Hualien
country: Taiwan
facility: Pfizer Investigational Site
city: Kaohsiung
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Adana
country: Turkey
facility: Pfizer Investigational Site
city: Istanbul
country: Turkey
facility: Pfizer Investigational Site
city: Izmir
country: Turkey
facility: Pfizer Investigational Site
city: Sihhiye-Ankara
country: Turkey
facility: Pfizer Investigational Site
city: Bristol
country: United Kingdom
facility: Pfizer Investigational Site
state: Avon
city: Crewe
country: United Kingdom
facility: Pfizer Investigational Site
state: Cheshire
city: Taunton
country: United Kingdom
facility: Pfizer Investigational Site
state: Somerset
city: London
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Chapple C, Herschorn S, Abrams P, Sun F, Brodsky M, Guan Z. Tolterodine treatment improves storage symptoms suggestive of overactive bladder in men treated with alpha-blockers. Eur Urol. 2009 Sep;56(3):534-41. doi: 10.1016/j.eururo.2008.11.026. Epub 2008 Nov 24.