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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
KYU-SUNG LEE, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00922506
First received: June 16, 2009
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Samsung Medical Center:

Primary Outcome Measures:
  • Numeric change of urgency episodes per 24 hours [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 260
Study Start Date: May 2009
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (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

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00922506

Contacts
Contact: Kyu-Sung Lee, Ph.D 82-2-3410-3554 ksleedr@skku.edu

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

No publications provided

Responsible Party: KYU-SUNG LEE, professor,MD,PhD, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00922506     History of Changes
Other Study ID Numbers: 2008-08-092
Study First Received: June 16, 2009
Last Updated: January 8, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Samsung Medical Center:
Overactive bladder
Benign prostate hyperplasia
Doxazosin
Tolterodine

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Urinary Bladder, Overactive
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Doxazosin
Phenylpropanolamine
Tolterodine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
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
Adrenergic alpha-Agonists
Adrenergic Agonists
Appetite Depressants

ClinicalTrials.gov processed this record on July 26, 2014