Urinary RetentionAURNCT00680680
Treatment of Refractory Urinary Retention Secondary to Benign Prostatic Hyperplasia (BPH) With Dual Five Alpha Reductase Inhibition Combined With an Alpha Blocker
A study testing Dutasteride in people with Urinary Retention and Benign Prostatic Hyperplasia, run by Franklin D. Gaylis, MD Inc..
Trial summary
To determine whether the addition of a dual Five Alpha Reductase Inhitor (Dutasteride) will alleviate urinary retention secondary to BPH in who have failed a voiding trial without a catheter. Following treatment with an Alpha Blocker alone. Read more about this study
- Who is it for?
- Ages 50 to 90 years, men only
- Conditions the study is for
- Urinary Retention, Benign Prostatic Hyperplasia
- What is being tested?
- Dutasteride
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- May 2004to Feb 2008
- Phase
- Interventional
- 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 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males betewen the ages of 50 and 90 years of age.Written informed consent.
- Men with acute urinary retention attributed to bladder outlet obstruction caused by BPH, who have failed atleast 1 week trial of alpha blocker treatment.
- PSA level equal to or greater than 1.5ng/ml and equal to or less than 15 ng/ml.
Who cannot join
- Urinary retention attributed to a neurogenic or myogenic bladder dysfunction.
- Use of psychotrophic medications.
- Use of antichollinergic medications.
- Prostate cancer.
- Allery to five alpha reductase inhibitors.
- Prior prostate surgery.
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- Urethral stricture.
- Bladder calculi.
- Invasive bladder cancer.
- Inability to understand or agree with the requirements of the study.
- Any investigational drug received within 30 days prior of study entry.
About this study
Official title: Phase 4 Study of Dual Five Alpha Reductase Inhibition Combined With Alpha Blockade in Men With Refractory Urinary Retention Secondary to BPH
To determine whether the addition of a dual Five Alpha Reductase Inhitor (Dutasteride) will alleviate urinary retention secondary to BPH in who have failed a voiding trial without a catheter. Following treatment with an Alpha Blocker alone.
- Conditions
- Urinary Retention, Benign Prostatic Hyperplasia
- Being tested
- Dutasteride
- Keywords
- Urinary retention secondary to benign prostatic hyperplasia
- Medical subject headings
- Urinary Retention, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DutasterideDrug
Patients will continue on their alpha blocker in addition to Dutasteride 0.5mg daily for a maximum of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2008 (estimated)
- Study startMay 2004
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary RetentionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Franklin D. Gaylis, MD Inc.
- Sponsor type
- University, hospital or other
- Investigators
- Franklin D Gaylis, MD, Principal investigator, Director/Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00680680
- Sponsor's protocol ID
- AUR
- Acronym
- AUR
- Status last verified
- May 2008
- First submitted
- 16 May 2008
- Last updated
- 20 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Dual Five Alpha Reductase Inhibition Combined With Alpha Blockade in Men With Refractory Urinary Retention Secondary to BPH
- ClinicalTrials.gov ID
- NCT00680680
- Acronym / sponsor ID
- AUR / AUR
- Conditions
- Urinary Retention, Benign Prostatic Hyperplasia
- Keywords
- Urinary retention secondary to benign prostatic hyperplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Franklin D. Gaylis, MD Inc.University, hospital or other
- Study start
- May 2004
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 20 May 2008 (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.
To determine whether the addition of a dual Five Alpha Reductase Inhitor (Dutasteride) will alleviate urinary retention secondary to BPH in who have failed a voiding trial without a catheter. Following treatment with an Alpha Blocker alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 50 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males betewen the ages of 50 and 90 years of age.Written informed consent.
- Men with acute urinary retention attributed to bladder outlet obstruction caused by BPH, who have failed atleast 1 week trial of alpha blocker treatment.
- PSA level equal to or greater than 1.5ng/ml and equal to or less than 15 ng/ml.
Key exclusion criteria (11 listed)
- Urinary retention attributed to a neurogenic or myogenic bladder dysfunction.
- Use of psychotrophic medications.
- Use of antichollinergic medications.
- Prostate cancer.
- Allery to five alpha reductase inhibitors.
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 |
|---|---|---|
| DutasteridePatients will continue on their alpha blocker in addition to Dutasteride 0.5mg daily for a maximum of 3 months | Drug | – |
Primary outcome
Not reported in the source record.
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 20 May 2008.
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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.
Franklin D Gaylis, MD principal investigator
Director/Sponsor
Questions about this trial
What is this clinical trial studying?
A study testing Dutasteride in people with Urinary Retention and Benign Prostatic Hyperplasia, run by Franklin D. Gaylis, MD Inc..
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 3 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 20 May 2008. Status can change between updates, so confirm with the study contact before making plans.
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.
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.
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 20 May 2008.