Prostatic HyperplasiaNCT00563654
Randomized Trial Comparing Alfuzosin GITS 10 mg Daily With Placebo for Trial Without Catheter in Acute Urinary Retention With Long Term Follow up
A study testing Alfuzosin GITS (Xatral XL) in people with Prostatic Hyperplasia and Urinary Retention, run by Hospital Authority, Hong Kong at 1 site in China.
Trial summary
The purpose of the study is to compare alfuzosin GITS once daily versus placebo in achieving a successful TWOC after AUR due to BPH, among Chinese males in Hong Kong, and in delaying or avoiding a TURP. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Prostatic Hyperplasia, Urinary Retention, Acute Disease
- What is being tested?
- Alfuzosin GITS (Xatral XL)
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- Oct 2005to Nov 2006
- 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 years and older
- Men only
- Adult, Older adult
Who may be able to join
- Aged 50 or above
- Admitted for AUR due to BPH with PVR of 500 ml or more
Who cannot join
- Previous history of TURP
- Use of alpha blockers within recent 8 months
- Renal impairment (serum creatinine >140 umol/l)
- Poor premorbid state
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial Comparing Alfuzosin GITS 10 mg Daily With Placebo on the Successful Rate of Trial Without Catheter in Patients With Acute Urinary Retention With Long Term Follow up
The purpose of the study is to compare alfuzosin GITS once daily versus placebo in achieving a successful TWOC after AUR due to BPH, among Chinese males in Hong Kong, and in delaying or avoiding a TURP.
- Conditions
- Prostatic Hyperplasia, Urinary Retention, Acute Disease
- Being tested
- Alfuzosin GITS (Xatral XL)
- Keywords
- Benign Prostatic Hyperplasia (BPH), Acute Retention of Urine (AUR)
- Medical subject headings
- Prostatic Hyperplasia, Urinary Retention, Acute Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alfuzosin GITS (Xatral XL)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful rate of Trial Without Catheter (TWOC) at phase 1
Measured: At discharge after TWOC (at the end phase one)
Late failure of TWOC of, which is defined as recurrent of AUR or the need of invasive therapy among those who are successful in TWOC in phase 1
Measured: From the end of phase one to eight months after successful TWOC (the end of phase 2)
Secondary outcomes (2)
Proportion of subjects with hypotension or symptoms related to hypotension after administration of treatment drug for TWOC
Measured: From the time of treatment drug administration to the end of phase 1
Peak flow rate (Qmax), voided volume (Vcomp) and post-voided residue volume (PVR)
Measured: At the end of phase I (discharge after TWOC) and at the end of phase 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2007 (estimated)
- Study startOct 2005
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic HyperplasiaStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Investigators
- Chi Wai Cheng, Dr, Principal investigator, Department of Surgery, Division of Urology, North District Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00563654
- Sponsor's protocol ID
- CRE-2005.332
- Other IDs
- HARECCTR0500048
- Status last verified
- Jun 2011
- First submitted
- 21 Nov 2007
- Last updated
- 16 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing Alfuzosin GITS 10 mg Daily With Placebo on the Successful Rate of Trial Without Catheter in Patients With Acute Urinary Retention With Long Term Follow up
- ClinicalTrials.gov ID
- NCT00563654
- Acronym / sponsor ID
- CRE-2005.332
- Conditions
- Prostatic Hyperplasia, Urinary Retention, Acute Disease
- Keywords
- Benign Prostatic Hyperplasia (BPH), Acute Retention of Urine (AUR)
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Study start
- Oct 2005
- Study completion
- Nov 2006 (actual)
- First posted
- 26 Nov 2007 (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.
The purpose of the study is to compare alfuzosin GITS once daily versus placebo in achieving a successful TWOC after AUR due to BPH, among Chinese males in Hong Kong, and in delaying or avoiding a TURP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 50 or above
- Admitted for AUR due to BPH with PVR of 500 ml or more
Key exclusion criteria (4 listed)
- Previous history of TURP
- Use of alpha blockers within recent 8 months
- Renal impairment (serum creatinine >140 umol/l)
- Poor premorbid state
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 |
|---|---|---|
| Alfuzosin GITS (Xatral XL) | Drug | – |
Primary outcome
Successful rate of Trial Without Catheter (TWOC) at phase 1
Time frame: At discharge after TWOC (at the end phase one)
Late failure of TWOC of, which is defined as recurrent of AUR or the need of invasive therapy among those who are successful in TWOC in phase 1
Time frame: From the end of phase one to eight months after successful TWOC (the end of phase 2)
2 secondary outcomes
Proportion of subjects with hypotension or symptoms related to hypotension after administration of treatment drug for TWOC
Time frame: From the time of treatment drug administration to the end of phase 1
Peak flow rate (Qmax), voided volume (Vcomp) and post-voided residue volume (PVR)
Time frame: At the end of phase I (discharge after TWOC) and at the end of phase 2
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2011.
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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.
Chi Wai Cheng, Dr principal investigator
Department of Surgery, Division of Urology, North District Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alfuzosin GITS (Xatral XL) in people with Prostatic Hyperplasia and Urinary Retention, run by Hospital Authority, Hong Kong at 1 site in China.
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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 16 Jun 2011. 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 China. 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.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Successful rate of Trial Without Catheter (TWOC) at phase 1 (time frame: At discharge after TWOC (at the end phase one)). The study lists 2 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 16 Jun 2011.