Detrol LA In Men With Overactive Bladder.

NCT00282932 | Completed Phase 4

• 1 other identifier: A6121127
• Study Type: interventional
• Target: 600
• Locations: 15 countries
• Sites: 81

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.

Conditions

Overactive Bladder (OAB)

Outcome Measures

Primary Outcomes (1)

• Patient Perception of Bladder Condition at 12 weeks of treatment

Secondary Outcomes (6)

• 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

Interventions

Detrol LA DRUG

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Significant hepatic or renal disease, history of radiation treatment

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (81)

Pfizer Investigational Site

Anaheim, California, 92801, United States

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La Mesa, California, 91942, United States

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Aurora, Colorado, 80012, United States

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Iowa City, Iowa, 52242-1089, United States

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Shreveport, Louisiana, 71106, United States

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Watertown, Massachusetts, 02472, United States

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Woodlane, New Jersey, 08060, United States

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New York, New York, 10016, United States

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Cincinnati, Ohio, 45212, United States

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State College, Pennsylvania, 16801, United States

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Houston, Texas, 77024, United States

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Calgary, Alberta, T2V 4R6, Canada

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Surrey, British Columbia, V3V 1N1, Canada

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Victoria, British Columbia, V8T5G1, Canada

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Kingston, Ontario, K7L 3J7, Canada

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London, Ontario, N6A 4V2, Canada

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Oakville, Ontario, L6H 3P1, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Toronto, Ontario, M5T 2S8, Canada

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Toronto, Ontario, M6A 3B5, Canada

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Montreal, Quebec, H2X 1N8, Canada

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Montreal, Quebec, H3S 1Z1, Canada

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Pointe-Claire, Quebec, H9R 4S3, Canada

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Aalborg, 9100, Denmark

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Herlev, DK-2730, Denmark

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Nykøbing Falster, 4800, Denmark

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Berlin, 13347, Germany

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Duisburg, 47179, Germany

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Frankfurt, 65929, Germany

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Muelheim A.d. Ruhr, 45468, Germany

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München, 81369, Germany

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München, 81925, Germany

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Rosenheim, 83022, Germany

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Starnberg, 82319, Germany

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Latina, 04100, Italy

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Padua, 35128, Italy

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Guadalajara, Jalisco, 44100, Mexico

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Zapopan, Jalisco, 45200, Mexico

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Tlalpan, México DF, 14000, Mexico

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Durango, 34000, Mexico

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Durango, 34079, Mexico

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Bodø, 8087, Norway

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Moelv, 2391, Norway

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Bratislava, 833 05, Slovakia

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Košice, 040 11, Slovakia

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Malacky, 901 01, Slovakia

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Martin, 036 01, Slovakia

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Skalica, 909 82, Slovakia

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Bloemfontein, Free State, 9300, South Africa

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Bloemfontein, Free State, 9301, South Africa

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Parktown, Gauteng, 2193, South Africa

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Durban, KwaZulu-Natal, 4001, South Africa

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Pietermaritzburg, KwaZulu-Natal, 3201, South Africa

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Cape Town, 8001, South Africa

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Bucheon-si, Gyunggi-do, 420-717, South Korea

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Busan, 602-739, South Korea

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Seoul, 135-270, South Korea

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Seoul, 138-736, South Korea

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A Coruña, A Coruña, 15006, Spain

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Palma de Mallorca, Balearic Islands, 07014, Spain

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Barcelona, 08025, Spain

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Granada, 18014, Spain

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Madrid, 28016, Spain

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Madrid, 28040, Spain

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Valencia, 46009, Spain

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Borås, 503 32, Sweden

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Huskvarna, 561 36, Sweden

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Lund, 221 85, Sweden

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Skövde, 541 30, Sweden

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Hualien City, 970, Taiwan

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Kaohsiung City, 833, Taiwan

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Taipei, 100, Taiwan

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Taipei, Taiwan

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Adana, 01230, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Izmir, 35100, Turkey (Türkiye)

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Sihhiye-Ankara, Turkey (Türkiye)

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Bristol, Avon, BS10 5NB, United Kingdom

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Crewe, Cheshire, CW1 4QJ, United Kingdom

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Taunton, Somerset, TA1 5DA, United Kingdom

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London, N19 5LW, United Kingdom

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Related Publications (1)

• 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.

  PMID: 19070418 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Tolterodine Tartrate

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)

Phenylpropanolamine; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cresols; Phenols

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 26, 2006
• First Posted: January 27, 2006
• Study Start: January 1, 2006
• Primary Completion: May 1, 2007
• Study Completion: May 14, 2007
• Last Updated: January 27, 2021

Record last verified: 2021-01

Locations

ZA (6); KR (4); SE (4); CA (12); TW (4); NO (2); DE (8); GB (4); IT (2); ES (7); ME (5); TU (4); SL (5); DK (3); US (11)