Benign Prostatic HyperplasiaNCT01958892
To Compare Outcomes After Transurethral Enucleation of Prostate Versus Transurethral Resection of Prostate
An observational study of Benign Prostatic Hyperplasia, run by Singapore General Hospital at 2 sites in Singapore.
Trial summary
The purpose of the study is to assess whether transurethral enucleation of prostate gives better or equivalent outcomes compared to the gold standard of transurethral resection of the prostate Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- TURP, TUERP
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 2 sitesSingapore
- Study dates
- Start not givento Oct 2012
- Phase
- Observational
- 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 Any age
- Men only
- Child, Adult, Older adult
Study population: Amles who underwent transurethral prostate surgeryr between 2006 and 2010
Who may be able to join
- All who underwent TURP or TUERP
Who cannot join
- Those with prostate cancer, neurogenic bladder, previous urethral or prostate surgery
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
Singapore General Hospital
S'pore, S'pore, 120355
Singapore General Hospital
Singapore
About this study
The purpose of the study is to assess whether transurethral enucleation of prostate gives better or equivalent outcomes compared to the gold standard of transurethral resection of the prostate
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- TURP, TUERP
- Keywords
- BPH
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TURP, TUERPProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| TURP | Not described Receives: Procedure: TURP, TUERP | |
| TUERP | Not described Receives: Procedure: TURP, TUERP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum urinary flow rate
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Primary completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Palaniappan Sundaram, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01958892
- Sponsor's protocol ID
- 2012/311/D
- Status last verified
- Oct 2013
- First submitted
- 5 Oct 2013
- Last updated
- 9 Oct 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare Outcomes After Transurethral Enucleation of Prostate Versus Transurethral Resection of Prostate
- ClinicalTrials.gov ID
- NCT01958892
- Acronym / sponsor ID
- 2012/311/D
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- BPH
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Primary completion
- Oct 2012 (actual)
- First posted
- 9 Oct 2013 (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 assess whether transurethral enucleation of prostate gives better or equivalent outcomes compared to the gold standard of transurethral resection of the prostate
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TURP | – | Procedure: TURP, TUERP |
| TUERP | – | Procedure: TURP, TUERP |
Who may qualify
- Sex
- Male only
- Age groups
- Child, Adult, Older adult
- Study population
- Amles who underwent transurethral prostate surgeryr between 2006 and 2010
Key inclusion criteria (1 listed)
- All who underwent TURP or TUERP
Key exclusion criteria (1 listed)
- Those with prostate cancer, neurogenic bladder, previous urethral or prostate surgery
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 |
|---|---|---|
| TURP, TUERP | Procedure or surgery | TUERP, TURP |
Primary outcome
Maximum urinary flow rate
Time frame: 6 weeks
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 9 Oct 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Prostatic Hyperplasia, run by Singapore General Hospital at 2 sites in Singapore.
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 1 inclusion and 1 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 9 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. 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 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?
Maximum urinary flow rate (time frame: 6 weeks). 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 9 Oct 2013.