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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Overactive Bladder; Benign Prostatic Hyperplasia	Drug: doxazosin plus tolterodine SR	Phase 4

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	260 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (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"
Study Start Date :	May 2009
Estimated Primary Completion Date :	November 2015
Estimated Study Completion Date :	November 2015

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Numeric change of urgency episodes per 24 hours [ Time Frame: 12 weeks of treatment ]

Secondary Outcome Measures :

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

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	50 Years to 80 Years (Adult, Senior)
Sexes 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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted:	June 17, 2009
Last Update Posted:	February 16, 2015
Last Verified:	January 2014

Keywords provided by KYU-SUNG LEE, Samsung Medical Center:

Overactive bladder; Benign prostate hyperplasia; Doxazosin; Tolterodine

Additional relevant MeSH terms:

Hyperplasia; 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; Doxazosin	Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Urological Agents; Antihypertensive Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Adrenergic Antagonists; Adrenergic Agents