Post-Operative Urinary RetentionNCT02684344
Prophylactic Tamsulosin Use for Prevention of Post-Operative Urinary Retention
A study testing Tamsulosin and Education in people with Post-Operative Urinary Retention, run by University of Rochester at 1 site in United States.
Trial summary
This randomized open-label study will be comprised of 2 cohorts: one control group and one treatment group. The trial will be conducted as an open label randomized trial to evaluate the efficacy of tamsulosin in the prevention of post-operative urinary retention. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Post-Operative Urinary Retention
- What is being tested?
- Tamsulosin and Education
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Dec 2017
- Phase
- Interventional
- 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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any male age 40 or older
- Scheduled to undergo one of the planned surgeries (thoracic, general, or urologic)
- Ability to give informed consent
Who cannot join
- Current use of alpha blocker
- Current use of a strong CYP 3A4 inhibitors
- Any allergy to tamsulosin, alpha-blocker medication class, or anaphylaxis allergy to sulfate containing medications
- Patients with any upcoming surgery for cataracts
- Currently enrolled in a clinical trial
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
This randomized open-label study will be comprised of 2 cohorts: one control group and one treatment group. The trial will be conducted as an open label randomized trial to evaluate the efficacy of tamsulosin in the prevention of post-operative urinary retention. The study will include pre- and post-surgical evaluations of patients including symptoms of urinary retention and any adverse effects contributable to the study medication.
- Conditions
- Post-Operative Urinary Retention
- Being tested
- Tamsulosin, Education
- Keywords
- Post-Operative Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamsulosinDrug
Also called Flomax
Tamsulosin may have prophylactic properties against post-operative urinary retention
EducationOther
Education about signs and symptoms of urinary retention
| Study group | Role | What they receive |
|---|---|---|
| Tamsulosin Group | Experimental | Subjects will receive:
1. 0.4mg tamsulosin by mouth nightly for 3 doses prior to the day of surgery and for 2 doses following surgery
2. education about signs and symptoms of urinary retention Receives: Drug: Tamsulosin; Other: Education |
| Education Group | Active comparator | Subjects will receive:
1) education about signs and symptoms of urinary retention Receives: Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Post-operative Urinary Retention
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2017
- Study completionDec 2017
Why it stopped: Lack of enrollment
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 Post-Operative Urinary RetentionStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward Messing, University of Rochester
- Investigators
- Edward E. Messing, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02684344
- Sponsor's protocol ID
- 59730
- Status last verified
- Jan 2019
- First submitted
- 8 Feb 2016
- Last updated
- 23 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Tamsulosin Use for Prevention of Post-Operative Urinary Retention
- ClinicalTrials.gov ID
- NCT02684344
- Acronym / sponsor ID
- 59730
- Conditions
- Post-Operative Urinary Retention
- Keywords
- Post-Operative Urinary Retention
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 18 Feb 2016 (estimated)
- Results
- Posted 23 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized open-label study will be comprised of 2 cohorts: one control group and one treatment group. The trial will be conducted as an open label randomized trial to evaluate the efficacy of tamsulosin in the prevention of post-operative urinary retention. The study will include pre- and post-surgical evaluations of patients including symptoms of urinary retention and any adverse effects contributable to the study medication.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tamsulosin Group | Experimental | Drug: Tamsulosin, Other: EducationSubjects will receive: 1. 0.4mg tamsulosin by mouth nightly for 3 doses prior to the day of surgery and for 2 doses following surgery 2. education about signs and symptoms of urinary retention |
| Education Group | Active comparator | Other: EducationSubjects will receive: 1) education about signs and symptoms of urinary retention |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Any male age 40 or older
- Scheduled to undergo one of the planned surgeries (thoracic, general, or urologic)
- Ability to give informed consent
Key exclusion criteria (6 listed)
- Current use of alpha blocker
- Current use of a strong CYP 3A4 inhibitors
- Any allergy to tamsulosin, alpha-blocker medication class, or anaphylaxis allergy to sulfate containing medications
- Patients with any upcoming surgery for cataracts
- Currently enrolled in a clinical trial
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 |
|---|---|---|
| TamsulosinAlso: FlomaxTamsulosin may have prophylactic properties against post-operative urinary retention | Drug | Tamsulosin Group |
| EducationEducation about signs and symptoms of urinary retention | Other | Education Group, Tamsulosin Group |
Primary outcome
Number of Participants With Post-operative Urinary Retention
Time frame: 5 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Edward E. Messing, MD principal investigator
University of Rochester
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 and Education in people with Post-Operative Urinary Retention, run by University of Rochester 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 3 inclusion and 6 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 23 Jan 2019. 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. 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?
Yes. Results are posted in the registry (first posted 23 Jan 2019). 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?
Number of Participants With Post-operative Urinary Retention (time frame: 5 days). 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 23 Jan 2019; AzTrials last refreshed its copy on 7 Nov 2026.