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Detrol LA In Men With Overactive Bladder.

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00282932
First received: January 26, 2006
Last updated: September 5, 2007
Last verified: September 2007
History of Changes

January 26, 2006
September 5, 2007
January 2006
Not Provided
Patient Perception of Bladder Condition at 12 weeks of treatment
Same as current
Complete list of historical versions of study NCT00282932 on ClinicalTrials.gov Archive Site
  • 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
  • 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
  • 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),
  • 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
  • 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
  • incontinence.
Bladder diary endpoints, quality of life, treatment satisfaction Note: The list of secondary measures has been modified due to commercial sensitivity. Full list will be provided at a later date.
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Detrol LA In Men With Overactive Bladder.
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.

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Overactive Bladder (OAB)
Drug: Detrol LA
Not Provided
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. Epub 2008 Nov 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
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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
Male
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Denmark,   Germany,   Italy,   Korea, Republic of,   Mexico,   Norway,   Slovakia,   South Africa,   Spain,   Sweden,   Taiwan,   Turkey,   United Kingdom
 
NCT00282932
A6121127
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP