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Combination Treatment With Doxazosin Plus TolterodineSR 2 mg Versus 4mg in Men With an Overactive Bladder (OAB) and Benign Prostatic Hyperplasia (BPH)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2014 by KYU-SUNG LEE, Samsung Medical Center.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
KYU-SUNG LEE, Samsung Medical Center Identifier:
First received: June 16, 2009
Last updated: February 12, 2015
Last verified: January 2014

OAB occurs in approximately 50% to 75% of men with BPO and up to 38% of men with BPO continue to suffer from OAB after relief the obstruction.Symptoms of OAB are more bothersome than the voiding complaints of slow stream and hesitancy. However, the patients with both BPO and OAB are often not treated with muscarinic receptor antagonists due to concern that they will experience acute urinary retention.

Tolterodine is a potent and pure muscarinic receptor antagonist that was developed specifically for the treatment of overactive bladder. Recently, studies revealed that tolterodine was effective, safe and well tolerated in adults with OAB and urodynamically confirmed BPO.However, the optimal dosage of antimuscarinic for the treatment of OAB coexisting BPO was not yet fully assessed. In real clinical situation, some patients complain voiding difficulty after addition of antimuscarinics and want to stop antimuscarinics.It is probable that a lower dosage of antimuscarinics combined with alpha-adrenergic antagonists can be used safely in OAB patients with BOO, with the same efficacy.

This study is designed to investigate the optimal doses of tolterodine SR in combination with doxazosin in men with both BOO and OAB based on efficacy, safety, and tolerability.

Condition Intervention Phase
Overactive Bladder
Benign Prostatic Hyperplasia
Drug: doxazosin plus tolterodine SR
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of the Efficacy and Safety of Combination Treatment With Doxazosin Plus TolterodineSR 2 mg vs Doxazosin Plus TolterodineSR 4 mg in Men With an OAB/BPO: Randomized Controlled Study"

Resource links provided by NLM:

Further study details as provided by KYU-SUNG LEE, Samsung Medical Center:

Primary Outcome Measures:
  • Numeric change of urgency episodes per 24 hours [ Time Frame: 12 weeks of treatment ]

Secondary Outcome Measures:
  • Changes in voiding diary parameters [ Time Frame: 12 weeks of treatment ]
  • Change in symptom questionnaires [ Time Frame: 12 weeks ]
  • Patient-Rated Global Assessments of Treatment Benefit, Satisfaction, and Willingness to Continue [ Time Frame: 12 weeks ]
  • Change of uroflowmetry and PVR [ Time Frame: 12 weeks ]
  • Incidence of acute urinary retention [ Time Frame: during all study periods ]

Estimated Enrollment: 260
Study Start Date: May 2009
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: doxazosin plus tolterodine SR 2 mg
doxazosin plus tolterodine SR(2 mg, qd) for 12 weeks
Drug: doxazosin plus tolterodine SR
doxazosin plus tolterodine SR(2 mg, qd)for 12 weeks or (4 mg, qd) for 12 weeks
Other Names:
  • Cadura XL 4mg or 8mg
  • Detrusitol SR 2mg
Experimental: doxazosin plus tolterodine SR 4 mg
doxazosin plus tolterodine SR(4 mg,qd) for 12 weeks
Drug: doxazosin plus tolterodine SR
doxazosin plus tolterodine SR(2 mg, qd)for 12 weeks or (4 mg, qd) for 12 weeks
Other Names:
  • Cadura XL 4mg or 8mg
  • Detrusitol SR 2mg


Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male aged 50 ≤ and ≤ 80 years
  • Proven bladder outlet obstruction (BOO, Abrams/Griffith score >20) on urodynamic study
  • Symptoms of OAB as verified by the 3 day voiding diary, defined by:

    1. symptoms of urinary urgency (defined as a level of ≥3 in a 5 point urgency scale) at least two episode per 24 hours and
    2. symptoms of urinary frequency (8 micturitions per 24 hours)
  • Total International Prostate Symptom Score (IPSS) of 12 or higher
  • IPSS quality-of-life (QOL) item score of 3 or higher
  • A rating of the bladder condition at Baseline prior to randomization as "Some Moderate Problems", "Severe Problems", or "Many Severe Problems" on the Patient Perception of Bladder Condition (PPBC) questionnaire.
  • Ability and willingness to correctly complete the micturition diary and questionnaire
  • Capable of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risks and benefits

Exclusion Criteria:

  • Patients have a baseline post-void residual (PVR) which exceeded 150 mL.
  • Any condition that is a contraindication for anticholinergic treatment, including uncontrolled narrow-angled glaucoma, urinary retention or gastric retention.
  • Symptomatic acute urinary tract infection (UTI) during the screening period.
  • Treatment within the 14 days preceding randomization, or expected to initiate treatment during the study with any anticholinergic drugs and drug treatment for overactive bladder.
  • A 5-alpha reductase inhibitor if started less than 3 months prior to screening.
  • Patients with previous urethral, prostate or bladder neck surgery.
  • Patients with cancer of any type including cancer of the prostate or bladder, uncontrolled medical condition including psychiatric disease or life threatening illness.
  • Patients with Parkinson's disease, stroke, multiple sclerosis, spinal cord disease.
  • Patients with suspected neurogenic bladder disorder.
  • Patients with urethral stricture or bladder neck contracture.
  • Serum PSA 4ng/ml (only patients with no malignancy by prostate biopsy can be included).
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Please refer to this study by its identifier: NCT00922506

Contact: Kyu-Sung Lee, Ph.D 82-2-3410-3554

Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Kyu-Sung Lee, Ph.D    82-2-3410-3554   
Principal Investigator: Kyu-Sung Lee, Ph.D         
Sponsors and Collaborators
Samsung Medical Center
Principal Investigator: Kyu-Sung Lee, Ph.D Samsung Medical Center
  More Information

Responsible Party: KYU-SUNG LEE, professor,MD,PhD, Samsung Medical Center Identifier: NCT00922506     History of Changes
Other Study ID Numbers: 2008-08-092
Study First Received: June 16, 2009
Last Updated: February 12, 2015

Keywords provided by KYU-SUNG LEE, Samsung Medical Center:
Overactive bladder
Benign prostate hyperplasia

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Prostatic Hyperplasia
Pathologic Processes
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Prostatic Diseases
Genital Diseases, Male
Tolterodine Tartrate
Antihypertensive Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Urological Agents processed this record on May 25, 2017