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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT00922506
First Posted: June 17, 2009
Last Update Posted: February 16, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
KYU-SUNG LEE, Samsung Medical Center
June 16, 2009
June 17, 2009
February 16, 2015
May 2009
November 2015   (Final data collection date for primary outcome measure)
Numeric change of urgency episodes per 24 hours [ Time Frame: 12 weeks of treatment ]
Numeric change of urgency episodes per 24 hours [ Time Frame: from baseline to 12 weeks of treatment ]
Complete list of historical versions of study NCT00922506 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Changes in voiding diary parameters [ Time Frame: 12 weeks of treatment ]
  • Change in symptom questionnaires
  • Patient-Rated Global Assessments of Treatment Benefit, Satisfaction, and Willingness to Continue
  • Change of uroflowmetry and PVR
  • Incidence of acute urinary retention
Not Provided
Not Provided
 
Combination Treatment With Doxazosin Plus TolterodineSR 2 mg Versus 4mg in Men With an Overactive Bladder (OAB) and Benign Prostatic Hyperplasia (BPH)
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"

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Overactive Bladder
  • Benign Prostatic Hyperplasia
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 2 mg
    doxazosin plus tolterodine SR(2 mg, qd) for 12 weeks
    Intervention: Drug: doxazosin plus tolterodine SR
  • Experimental: doxazosin plus tolterodine SR 4 mg
    doxazosin plus tolterodine SR(4 mg,qd) for 12 weeks
    Intervention: Drug: doxazosin plus tolterodine SR
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
260
November 2015
November 2015   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: Male
50 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT00922506
2008-08-092
No
Not Provided
Not Provided
KYU-SUNG LEE, Samsung Medical Center
Samsung Medical Center
Not Provided
Principal Investigator: Kyu-Sung Lee, Ph.D Samsung Medical Center
Samsung Medical Center
January 2014

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