Benign Prostatic Hyperplasia (BPH)Phase 4LUTSNCT00939120
Dutasteride With Tolterodine ER or Placebo to Treat Lower Urinary Tract Symptoms (LUTS)
A Phase 4 study testing Tolterodine ER 4mg and Pre-randomization Dutasteride in people with Benign Prostatic Hyperplasia (BPH), run by Siami, Paul F., M.D. at 1 site in United States.
Trial summary
This is an investigator-initiated study of safety, efficacy and tolerability of dutasteride given for 18 months, including a 1-year double-blind randomized co-administration with either tolterodine ER or placebo in men suffering from lower urinary tract symptoms (LUTS) including urgency and frequency, with or without… Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia (BPH)
- What is being tested?
- Tolterodine ER 4mg and Pre-randomization Dutasteride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Sep 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- This subject population will consist of males ≥ 50 years of age who have lower urinary tract symptoms (LUTS) due to benign prostatic enlargement (BPE) for a minimum of 3 months
- Subjects who understand and speak English and are able to comply with the protocol, complete the diaries, and other study tools
- Subject has provided written informed consent and HIPAA authorization
- Ambulatory male subjects ≥ 50 years of age
- Able to use the toilet without difficulty
- History of LUTS due to BPE, as diagnosed by history as well as digital rectal exam (DRE), for ≥ 3 months suitable for medical therapy with 5-ARI in combination with antimuscarinic drugs
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- Prostate volume (PV) ≥ 30 cc as measured by transrectal ultrasound (TRUS)
- International prostate symptoms score (IPSS) ≥12
- Post Void Residual Volume < 150 mL at baseline
- Uroflowmetry-Qmax > 5 mL/sec and ≤ 15 mL/sec
- Prostate specific antigen (PSA) ≥ 1.5 ng/ml and in normal age-adjusted range. For those subjects with an elevated age-adjusted PSA, it is the responsibility of the investigator to take standard of care measures to assure reasonable absence of prostate cancer
- Have an average of ≥ 8 micturitions per 24 hrs
- Have an average of 2 episodes of urgency per 24 hrs (defined as those with the Urinary Sensation Scale rating of 3 or more)
Who cannot join
- Concurrent use of 5-ARI therapy within the past 3 months
- Concurrent use of alpha blockers within the past 2 weeks
- Concurrent use of antimuscarinics within the past 4 weeks
- Concurrent use of Phosphodiesterase type 5 (PDE-5) inhibitors on a daily basis
- Evidence of chronic inflammation such as interstitial cystitis and bladder stones.
- Evidence of untreated urethral stricture disease
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- Uncontrolled narrow angle glaucoma
- Increased post-void residual volume (PVR) defined as PVR > 150 mL
- Uroflowmetry-Qmax ≤ 5 mL/sec
- Acute urinary tract infection (UTI). These subjects may be treated and re-screened
- Acute urinary retention (AUR) requiring catheter within the last 3 months
- Previous or planned transurethral resection of the prostate (TURP)
- Minimally invasive surgery (MIS) such as transurethral microwave treatment (TUMT), transurethral needle ablation (TUNA), laser, or other minimally invasive procedures within 12 months. Those patients who in the opinion of the investigator did not respond adequately to MIS and fulfill the inclusion criteria are eligible to participate
- A known diagnosis of prostate cancer.
- A known diagnosis of bladder cancer within 5 years of screening. Those patients with history of non-muscle invasive bladder cancer who have not had a recurrence in the past 5 years are eligible to screen for this study and must maintain continued adequate bladder cancer screening at the discretion of the Investigator
- Renal or hepatic impairment defined as 2.5 x upper limit of normal. Some isolated abnormalities would be left at the discretion of the investigator with always keeping in mind to not pose a hazard to the patient.
- PSA > 10 ng/mL (if the PSA is greater than 4 ng/mL and less than or equal to 10 ng/mL, subjects may be included at the discretion of the Investigator if the PSA has been stable and the patient has had a prostate biopsy showing no evidence of prostate cancer)
- Known or suspected hypersensitivity to dutasteride or tolterodine ER .
- Participation in a clinical trial involving an investigational drug, within 30 days prior to enrollment.
- History of diagnosed gastrointestinal obstruction disease.
- Myocardial infarction within the past 8 weeks.
- Known or suspected drug and/or alcohol abuse.
- Any clinical condition, which, in the opinion of the Investigator, would not allow safe completion of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Deaconess Clinic Gateway Health Center
Newburgh, Indiana, 47630
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Study of Safety and Efficacy of Dutasteride in Combination With Tolterodine ER or Placebo in Men With Lower Urinary Tract Symptoms (LUTS) Including Urgency and Frequency
This is an investigator-initiated study of safety, efficacy and tolerability of dutasteride given for 18 months, including a 1-year double-blind randomized co-administration with either tolterodine ER or placebo in men suffering from lower urinary tract symptoms (LUTS) including urgency and frequency, with or without urgency urinary incontinence (i.e., overactive bladder (OAB) symptoms).
Read the detailed description
Men who are treated with an alpha blocker (AB) or 5-alpha reductase inhibitor (5-ARI) for benign prostatic enlargement (BPE) and lower urinary tract symptoms (LUTS) often have symptoms including urinary frequency and urgency. ABs and 5-ARIs may improve the obstructive voiding symptoms but not necessarily the storage symptoms.
This study will evaluate the safety and efficacy of dutasteride 0.5 mg once daily for 6 months in an open label fashion. Those patients who continue to report storage urinary symptoms, will be randomized to receive dutasteride 0.5 mg once daily for an additional one year together with double-blind tolterodine ER 4 mg or matched tolterodine ER placebo once daily.
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Being tested
- Tolterodine ER 4mg, Placebo, Pre-randomization Dutasteride
- Keywords
- Benign prostatic hyperplasia (BPH), dutasteride, tolterodine ER
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tolterodine ER 4mgDrug
Also called Detrol LA
1:1 randomization to either Dutasteride 0.5mg orally once daily plus Tolterodine ER 4 mg orally once daily or Dutasteride 0.5mg orally once daily plus placebo once daily
PlaceboDrug
1:1 randomization to either Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily or Dutasteride 0.5mg orally once daily plus placebo once daily
Pre-randomization DutasterideDrug
All participants were on Dutasteride 0.5mg orally once daily prior to randomization.
| Study group | Role | What they receive |
|---|---|---|
| Tolterodine ER 4mg | Experimental | 1:1 randomization to either Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily or Dutasteride 0.5mg orally once daily plus placebo once daily Receives: Drug: Tolterodine ER 4mg; Drug: Pre-randomization Dutasteride |
| placebo | Placebo comparator | 1:1 randomization to either Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily or Dutasteride 0.5mg orally once daily plus placebo once daily Receives: Drug: Placebo; Drug: Pre-randomization Dutasteride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-void Residual (PVR) Volume
To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: post-voiding residual volume measured via ultrasound.
Measured: 12 months
Maximum Urine Flow Rate (Qmax).
To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: maximum urine flow rate (Qmax) measured via uroflowmetry.
Measured: 12 months
Urine Voided Volume (Voiding)
To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: urine voided volume (voiding) measured by uroflowmetry.
Measured: 12 months
Acute Urinary Retention (AUR)
To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: acute urinary attention (AUR) - inability to urinate requiring catheterization.
Measured: 12 months
Secondary outcomes (5)
Overactive Bladder Questionnaire (OABq)
To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: overactive bladder questionnaire (OABq) - 33 questions scored via 1-6 (higher scores indicate more severe symptoms), thus values ranged from 33-198.
Measured: 12 months
Patient Perception of Bladder Condition (PPBC)
To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: participant reported patient perception of bladder condition (PPBC), one question scored from 1-6, higher scores indicating more severe symptoms.
Measured: 12 months
International Prostate Symptoms Score (IPSS), Total
To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: total international prostate symptoms score (IPSS) - 7 questions scored from 0-5 (higher score indicating more severe symptoms), thus total scores ranged from 0-35.
Measured: 12 months
International Prostate Symptoms Score, Voiding Subscore
To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: voiding subscore of international prostate symptoms score (IPSS) - 4 questions scored from 0-5 (higher score indicating more severe symptoms), thus total scores ranged from 0-20.
Measured: 12 months
International Prostate Symptoms Score (IPSS), Storage Subscore
To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: storage subscore international prostate symptoms score (IPSS) - 3 questions scored from 0-5 (higher score indicating more severe symptoms), thus total scores ranged from 0-15.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Benign Prostatic Hyperplasia (BPH)Studies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siami, Paul F., M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, Pfizer
- Responsible party
- Principal investigator, Paul F. Siami, MD, Siami, Paul F., M.D.
- Investigators
- Paul F Siami, MD, Principal investigator, Deaconess Clinic Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00939120
- Sponsor's protocol ID
- 110983
- Acronym
- LUTS
- Status last verified
- Apr 2015
- First submitted
- 12 Jun 2009
- Last updated
- 1 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Study of Safety and Efficacy of Dutasteride in Combination With Tolterodine ER or Placebo in Men With Lower Urinary Tract Symptoms (LUTS) Including Urgency and Frequency
- ClinicalTrials.gov ID
- NCT00939120
- Acronym / sponsor ID
- LUTS / 110983
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Keywords
- Benign prostatic hyperplasia (BPH), dutasteride, tolterodine ER
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Siami, Paul F., M.D.University, hospital or other
- Collaborators
- GlaxoSmithKline, Pfizer
- Study start
- Jul 2009
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 14 Jul 2009 (estimated)
- Results
- Posted 1 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an investigator-initiated study of safety, efficacy and tolerability of dutasteride given for 18 months, including a 1-year double-blind randomized co-administration with either tolterodine ER or placebo in men suffering from lower urinary tract symptoms (LUTS) including urgency and frequency, with or without urgency urinary incontinence (i.e., overactive bladder (OAB) symptoms).
Detailed description
Men who are treated with an alpha blocker (AB) or 5-alpha reductase inhibitor (5-ARI) for benign prostatic enlargement (BPE) and lower urinary tract symptoms (LUTS) often have symptoms including urinary frequency and urgency. ABs and 5-ARIs may improve the obstructive voiding symptoms but not necessarily the storage symptoms.
This study will evaluate the safety and efficacy of dutasteride 0.5 mg once daily for 6 months in an open label fashion. Those patients who continue to report storage urinary symptoms, will be randomized to receive dutasteride 0.5 mg once daily for an additional one year together with double-blind tolterodine ER 4 mg or matched tolterodine ER placebo once daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tolterodine ER 4mg | Experimental | Drug: Tolterodine ER 4mg, Drug: Pre-randomization Dutasteride1:1 randomization to either Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily or Dutasteride 0.5mg orally once daily plus placebo once daily |
| placebo | Placebo comparator | Drug: Placebo, Drug: Pre-randomization Dutasteride1:1 randomization to either Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily or Dutasteride 0.5mg orally once daily plus placebo once daily |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- This subject population will consist of males ≥ 50 years of age who have lower urinary tract symptoms (LUTS) due to benign prostatic enlargement (BPE) for a minimum of 3 months
- Subjects who understand and speak English and are able to comply with the protocol, complete the diaries, and other study tools
- Subject has provided written informed consent and HIPAA authorization
- Ambulatory male subjects ≥ 50 years of age
- Able to use the toilet without difficulty
Key exclusion criteria (23 listed)
- Concurrent use of 5-ARI therapy within the past 3 months
- Concurrent use of alpha blockers within the past 2 weeks
- Concurrent use of antimuscarinics within the past 4 weeks
- Concurrent use of Phosphodiesterase type 5 (PDE-5) inhibitors on a daily basis
- Evidence of chronic inflammation such as interstitial cystitis and bladder stones.
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 |
|---|---|---|
| Tolterodine ER 4mgAlso: Detrol LA1:1 randomization to either Dutasteride 0.5mg orally once daily plus Tolterodine ER 4 mg orally once daily or Dutasteride 0.5mg orally once daily plus placebo once daily | Drug | Tolterodine ER 4mg |
| Placebo1:1 randomization to either Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily or Dutasteride 0.5mg orally once daily plus placebo once daily | Drug | placebo |
| Pre-randomization DutasterideAll participants were on Dutasteride 0.5mg orally once daily prior to randomization. | Drug | Tolterodine ER 4mg, placebo |
Primary outcome
Post-void Residual (PVR) Volume
Time frame: 12 months
To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: post-voiding residual volume measured via ultrasound.
Maximum Urine Flow Rate (Qmax).
Time frame: 12 months
To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: maximum urine flow rate (Qmax) measured via uroflowmetry.
Urine Voided Volume (Voiding)
Time frame: 12 months
To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: urine voided volume (voiding) measured by uroflowmetry.
Acute Urinary Retention (AUR)
Time frame: 12 months
To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: acute urinary attention (AUR) - inability to urinate requiring catheterization.
5 secondary outcomes
Overactive Bladder Questionnaire (OABq)
Time frame: 12 months
Patient Perception of Bladder Condition (PPBC)
Time frame: 12 months
International Prostate Symptoms Score (IPSS), Total
Time frame: 12 months
International Prostate Symptoms Score, Voiding Subscore
Time frame: 12 months
International Prostate Symptoms Score (IPSS), Storage Subscore
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Paul F Siami, MD principal investigator
Deaconess Clinic Research Institute
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 Tolterodine ER 4mg and Pre-randomization Dutasteride in people with Benign Prostatic Hyperplasia (BPH), run by Siami, Paul F., M.D. at 1 site in United States.
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 13 inclusion and 23 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 1 May 2015. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 1 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Post-void Residual (PVR) Volume (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2015.