Back to results

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

Primary Purpose

Overactive Bladder, Benign Prostatic Hyperplasia

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

doxazosin plus tolterodine SR

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring Overactive bladder, Benign prostate hyperplasia, Doxazosin, Tolterodine

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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).

Sites / Locations

Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

doxazosin plus tolterodine SR 2 mg

doxazosin plus tolterodine SR 4 mg

Arm Description

doxazosin plus tolterodine SR(2 mg, qd) for 12 weeks

doxazosin plus tolterodine SR(4 mg,qd) for 12 weeks

Outcomes

Primary Outcome Measures

Numeric change of urgency episodes per 24 hours

Secondary Outcome Measures

Changes in voiding diary parameters

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

Full Information

NCT ID

NCT00922506

First Posted

June 16, 2009

Last Updated

November 28, 2019

Sponsor

Samsung Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00922506

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

May 2009 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Samsung Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overactive Bladder, Benign Prostatic Hyperplasia

Keywords

Overactive bladder, Benign prostate hyperplasia, Doxazosin, Tolterodine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

83 (Actual)

8. Arms, Groups, and Interventions

Arm Title

doxazosin plus tolterodine SR 2 mg

Arm Type

Experimental

Arm Description

doxazosin plus tolterodine SR(2 mg, qd) for 12 weeks

Arm Title

doxazosin plus tolterodine SR 4 mg

Arm Type

Experimental

Arm Description

doxazosin plus tolterodine SR(4 mg,qd) for 12 weeks

Intervention Type

Drug

Intervention Name(s)

doxazosin plus tolterodine SR

Other Intervention Name(s)

Cadura XL 4mg or 8mg, Detrusitol SR 2mg

Intervention Description

doxazosin plus tolterodine SR(2 mg, qd)for 12 weeks or (4 mg, qd) for 12 weeks

Primary Outcome Measure Information:

Title

Numeric change of urgency episodes per 24 hours

Time Frame

12 weeks of treatment

Secondary Outcome Measure Information:

Title

Changes in voiding diary parameters

Time Frame

12 weeks of treatment

Title

Change in symptom questionnaires

Time Frame

12 weeks

Title

Patient-Rated Global Assessments of Treatment Benefit, Satisfaction, and Willingness to Continue

Time Frame

12 weeks

Title

Change of uroflowmetry and PVR

Time Frame

12 weeks

Title

Incidence of acute urinary retention

Time Frame

during all study periods

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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: 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kyu-Sung Lee, Ph.D

Organizational Affiliation

Samsung Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Samsung Medical Center

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs