Overactive BladderPhase 4NCT00922506
Combination Treatment With Doxazosin Plus TolterodineSR 2 mg Versus 4mg in Men With an Overactive Bladder (OAB) and Benign Prostatic Hyperplasia (BPH)
A Phase 4 study testing doxazosin plus tolterodine SR in people with Overactive Bladder and Benign Prostatic Hyperplasia, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Overactive Bladder, Benign Prostatic Hyperplasia
- What is being tested?
- doxazosin plus tolterodine SR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2009to Jun 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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"
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.
- Conditions
- Overactive Bladder, Benign Prostatic Hyperplasia
- Being tested
- doxazosin plus tolterodine SR
- Keywords
- Overactive bladder, Benign prostate hyperplasia, Doxazosin, Tolterodine
- Medical subject headings
- Urinary Bladder, Overactive, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doxazosin plus tolterodine SRDrug
Also called Cadura XL 4mg or 8mg, Detrusitol SR 2mg
doxazosin plus tolterodine SR(2 mg, qd)for 12 weeks or (4 mg, qd) for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| doxazosin plus tolterodine SR 2 mg | Experimental | doxazosin plus tolterodine SR(2 mg, qd) for 12 weeks Receives: Drug: doxazosin plus tolterodine SR |
| doxazosin plus tolterodine SR 4 mg | Experimental | doxazosin plus tolterodine SR(4 mg,qd) for 12 weeks Receives: Drug: doxazosin plus tolterodine SR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric change of urgency episodes per 24 hours
Measured: 12 weeks of treatment
Secondary outcomes (5)
Changes in voiding diary parameters
Measured: 12 weeks of treatment
Change in symptom questionnaires
Measured: 12 weeks
Patient-Rated Global Assessments of Treatment Benefit, Satisfaction, and Willingness to Continue
Measured: 12 weeks
Change of uroflowmetry and PVR
Measured: 12 weeks
Incidence of acute urinary retention
Measured: during all study periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KYU-SUNG LEE, Samsung Medical Center
- Investigators
- Kyu-Sung Lee, Ph.D, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00922506
- Sponsor's protocol ID
- 2008-08-092
- Status last verified
- Nov 2019
- First submitted
- 16 Jun 2009
- Last updated
- 2 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
PubMed 37160401
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT00922506
- Acronym / sponsor ID
- 2008-08-092
- Conditions
- Overactive Bladder, Benign Prostatic Hyperplasia
- Keywords
- Overactive bladder, Benign prostate hyperplasia, Doxazosin, Tolterodine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 17 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| doxazosin plus tolterodine SR 2 mg | Experimental | Drug: doxazosin plus tolterodine SRdoxazosin plus tolterodine SR(2 mg, qd) for 12 weeks |
| doxazosin plus tolterodine SR 4 mg | Experimental | Drug: doxazosin plus tolterodine SRdoxazosin plus tolterodine SR(4 mg,qd) for 12 weeks |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- Total International Prostate Symptom Score (IPSS) of 12 or higher
- IPSS quality-of-life (QOL) item score of 3 or higher
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| doxazosin plus tolterodine SRAlso: Cadura XL 4mg or 8mg, Detrusitol SR 2mgdoxazosin plus tolterodine SR(2 mg, qd)for 12 weeks or (4 mg, qd) for 12 weeks | Drug | doxazosin plus tolterodine SR 2 mg, doxazosin plus tolterodine SR 4 mg |
Primary outcome
Numeric change of urgency episodes per 24 hours
Time frame: 12 weeks of treatment
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
- Derived from this study: PubMed 37160401Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyu-Sung Lee, Ph.D principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing doxazosin plus tolterodine SR in people with Overactive Bladder and Benign Prostatic Hyperplasia, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric change of urgency episodes per 24 hours (time frame: 12 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00922506, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2019.