Prostatic Neoplasms, ProstatectomyNCT01209988
Impact of Tamsulosin on Voiding Patterns Following Early Catheter Removal After Robot-assisted Laparoscopic Radical Prostatectomy
A study testing tamsulosin 0.4mg and No medication in people with Prostatic Neoplasms, Prostatectomy, run by Asan Medical Center at 1 site in South Korea.
Trial summary
To date, there is a lack of consensus concerning the optimal timing for removal of the urethral catheter, its related complications, the effectiveness in prophylactic drug use to reduce complication, and the patient reported outcomes (quality of life) after robot-assisted laparoscopic prostatectomy (RALP). Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostatic Neoplasms, Prostatectomy
- What is being tested?
- tamsulosin 0.4mg and No medication
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2010to Dec 2011
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have localized or locally advanced prostate cancer
- Patients must receive robot assisted laparoscopic radical prostatectomy
- Patients must be able to provide written informed consent
Who cannot join
- Patients must not have a history of treatment with alpha blockers within 4 weeks
- Patients must not have previously undergone transurethral resection, laser therapy, or other surgery of the prostate
- Patients must not have previously been diagnosed with neurogenic bladder
- Patients must not have hypersensitivity to trial drug or other alpha-blockers
- Patients must not have the participation of other clinical trial within the past 3 months
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, 138-736
Choung-Soo Kim, M.D., cskim@amc.seoul.kr
About this study
Official title: A Prospective Randomized Study Examining the Impact of Tamsulosin on Voiding Patterns Following Early Catheter Removal After Robot-Assisted Laparoscopic Radical Prostatectomy
To date, there is a lack of consensus concerning the optimal timing for removal of the urethral catheter, its related complications, the effectiveness in prophylactic drug use to reduce complication, and the patient reported outcomes (quality of life) after robot-assisted laparoscopic prostatectomy (RALP). The purpose of this study is to determine the impact of tamsulosin on voiding patterns following early urethral catheter removal after RALP for prostate cancer.
- Conditions
- Prostatic Neoplasms, Prostatectomy
- Being tested
- tamsulosin 0.4mg, No medication
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tamsulosin 0.4mgDrug
perioperative tamsulosin 0.4mg daily for three weeks
No medicationOther
No medication
| Study group | Role | What they receive |
|---|---|---|
| Tamsulosin 0.4mg | Experimental | Perioperative tamsulosin 0.4mg daily Receives: Drug: tamsulosin 0.4mg |
| Control | Placebo comparator | No medication Receives: Other: No medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of acute urinary retention
Measured: within the 30 days after surgery
Secondary outcomes (1)
Patient reported outcomes
Measured: 20 days after surgery (plus or minus 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic Neoplasms, ProstatectomyStudies of the same condition, open and under way.
- More trials run by Asan 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Inc
- Investigators
- Choung-Soo Kim, M.D., Principal investigator, Department of Urology, Asan Medical Center, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01209988
- Sponsor's protocol ID
- AMC_UR_010
- Status last verified
- Sep 2010
- First submitted
- 27 Sep 2010
- Last updated
- 28 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study Examining the Impact of Tamsulosin on Voiding Patterns Following Early Catheter Removal After Robot-Assisted Laparoscopic Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT01209988
- Acronym / sponsor ID
- AMC_UR_010
- Conditions
- Prostatic Neoplasms, Prostatectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Astellas Pharma Inc
- Study start
- Apr 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 28 Sep 2010 (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 date, there is a lack of consensus concerning the optimal timing for removal of the urethral catheter, its related complications, the effectiveness in prophylactic drug use to reduce complication, and the patient reported outcomes (quality of life) after robot-assisted laparoscopic prostatectomy (RALP). The purpose of this study is to determine the impact of tamsulosin on voiding patterns following early urethral catheter removal after RALP for prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tamsulosin 0.4mg | Experimental | Drug: tamsulosin 0.4mgPerioperative tamsulosin 0.4mg daily |
| Control | Placebo comparator | Other: No medicationNo medication |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must have localized or locally advanced prostate cancer
- Patients must receive robot assisted laparoscopic radical prostatectomy
- Patients must be able to provide written informed consent
Key exclusion criteria (5 listed)
- Patients must not have a history of treatment with alpha blockers within 4 weeks
- Patients must not have previously undergone transurethral resection, laser therapy, or other surgery of the prostate
- Patients must not have previously been diagnosed with neurogenic bladder
- Patients must not have hypersensitivity to trial drug or other alpha-blockers
- Patients must not have the participation of other clinical trial within the past 3 months
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 |
|---|---|---|
| tamsulosin 0.4mgperioperative tamsulosin 0.4mg daily for three weeks | Drug | Tamsulosin 0.4mg |
| No medicationNo medication | Other | Control |
Primary outcome
The incidence of acute urinary retention
Time frame: within the 30 days after surgery
1 secondary outcome
Patient reported outcomes
Time frame: 20 days after surgery (plus or minus 3 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2010.
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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.
Choung-Soo Kim, M.D. principal investigator
Department of Urology, Asan Medical Center, Seoul, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tamsulosin 0.4mg and No medication in people with Prostatic Neoplasms, Prostatectomy, run by Asan 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 28 Sep 2010. 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. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Choung-Soo Kim, M.D. (82-2-3010-3734, cskim@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of acute urinary retention (time frame: within the 30 days after surgery). 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 28 Sep 2010.