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Completed

NCT Number: NCT00922506

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

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.

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Key information

Conditions

Overactive Bladder Benign Prostatic Hyperplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

50 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • symptoms of urinary urgency (defined as a level of ≥3 in a 5 point urgency scale) at least two episode per 24 hours and
  • 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).

Treatment and study plan

doxazosin plus tolterodine SR

Drug

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

Primary outcomes

  1. Numeric change of urgency episodes per 24 hours

    Time frame: 12 weeks of treatment

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study 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"

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Jun 17, 2009
Registry last updated
Dec 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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