Postoperative Urinary RetentionPhase 3NCT02518971
Trial of Prophylactic Tamsulosin for Postoperative Urinary Retention in Primary Total Hip and Knee Arthroplasty Patients
A Phase 3 study testing Tamsulosin in people with Postoperative Urinary Retention, run by University of Michigan at 1 site in United States.
Trial summary
The study aims to evaluate the efficacy of prophylactic tamsulosin in reducing the incidence of postoperative urinary retention in primary total knee and hip arthroplasty patients. Read more about this study
- Who is it for?
- Ages 35 years and older, men only
- Conditions the study is for
- Postoperative Urinary Retention
- What is being tested?
- Tamsulosin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to 19 Dec 2018
- Phase
- Phase 3
- 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 35 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men age 35 or older
- Primary total hip and knee arthroplasty patients (general, spinal, or epidural anesthesia
- No current use (>1 month) of alpha-blockers
- Community ambulator
- Adequate organ and marrow function as defined below:
- leucocytes at least 3,000/µL, absolute neutrophil count at least 1,500/µL, platelets at least 100,000/µL, creatinine within normal institutional limits
- Ability to understand, and the willingness to sign, a written informed consent
Who cannot join
- History of radical prostatectomy
- Receiving any other investigational agents
- Revision hip and knee arthroplasty patients
- Severe liver or kidney disease
- Taking strong inhibitors of CYP3A4 (ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir/ritonavir, lopinavir, or conivaptan)
- Being on alpha-blockers (alfuzosin, doxazosin, prazosin, terazosin, tamsulosin, phenoxybenzamine, or silodosin)
Show all 10Show fewer
- Being of 5-alpha reductase inhibitors (finasteride, dutasteride)
- History of allergy or sensitivity to tamsulosin or other alpha-blockers (alfuzosin, doxazosin, prazosin, terazosin, or phenoxybenzamine)
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Taking Sildenafil,Tadalafil, or Vardenafil
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Health System
Ann Arbor, Michigan, 48109
About this study
Official title: Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Prophylactic Tamsulosin for Postoperative Urinary Retention in Primary Total Hip and Knee Arthroplasty Patients
The study aims to evaluate the efficacy of prophylactic tamsulosin in reducing the incidence of postoperative urinary retention in primary total knee and hip arthroplasty patients.
Read the detailed description
Prophylactic administration of tamsulosin will be compared to a placebo to evaluate the effectiveness in reducing the incidence of postoperative urinary retention in total hip and knee arthroplasty patients.
- Conditions
- Postoperative Urinary Retention
- Being tested
- Tamsulosin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamsulosinDrug
Also called Flomax
0.4 mg daily
PlaceboDrug
one capsule daily
| Study group | Role | What they receive |
|---|---|---|
| tamsulosin | Experimental | 0.4 mg daily for five days pre-op through post-op day one (seven total) Receives: Drug: Tamsulosin |
| placebo | Placebo comparator | One capsule daily for five days pre-op through post-op day one (seven total) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients to Develop Postoperative Urinary Retention (POUR)
Patients who have not developed POUR will have two consecutive, spontaneous urine voids with residual volume of less than 200 mL, as determined by bladder scan or straight catheterization. Patients who do not successfully have the two spontaneous urine voids of less than 200 mL will be considered as having developed POUR. The incidence of POUR will be compared statistically between those taking and not taking tamsulosin at the time of surgery.
Measured: Postop day 1
Secondary outcomes (5)
Length of Hospital Stay
Length of hospital stay will be recorded in days and compared statistically between the two groups .
Measured: 1-4 days postoperative
Incidence of Discharge to a Skilled Nursing Facility
Discharge to a skilled nursing facility will be recorded (yes/no) and compared statistically between the two groups.
Measured: 1-4 days postoperative
Incidence of Surgical Site Infection
Surgical site infection will be recorded (yes/no) and compared statistically between the two groups.
Measured: Up to two weeks postoperative
Acute Postoperative Pain Medication Dosages
The dosages of postoperative pain medications will be compared statistically between the two groups.
Measured: Postoperative day 1 to day of discharge (1-4 days on average)
Incidence of Postoperative Complications
Postoperative complications will be recorded and the incidence will be compared statistically between the two groups.
Measured: Up to 31 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2015 (estimated)
- Study startAug 2015
- Primary completion5 Jun 2018
- Study completion19 Dec 2018
Why it stopped: interim analysis revealed no significant difference between study groups \& increased sample size required to gain significance.
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 Postoperative Urinary RetentionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Urquhart, University of Michigan
- Investigators
- Andrew Urquhart, MD, Principal investigator, University of Michigan, Dept of Orthopaedic SurgeryManuel Schubert, MD, Study director, University of Michigan, Dept of Orthopaedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02518971
- Sponsor's protocol ID
- HUM00087825
- Status last verified
- Mar 2019
- First submitted
- 27 Jul 2015
- Last updated
- 12 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Prophylactic Tamsulosin for Postoperative Urinary Retention in Primary Total Hip and Knee Arthroplasty Patients
- ClinicalTrials.gov ID
- NCT02518971
- Acronym / sponsor ID
- HUM00087825
- Conditions
- Postoperative Urinary Retention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: interim analysis revealed no significant difference between study groups \& increased sample size required to gain significance.
- Enrolment
- 176 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- 5 Jun 2018 (actual)
- Study completion
- 19 Dec 2018 (actual)
- First posted
- 10 Aug 2015 (estimated)
- Results
- Posted 12 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to evaluate the efficacy of prophylactic tamsulosin in reducing the incidence of postoperative urinary retention in primary total knee and hip arthroplasty patients.
Detailed description
Prophylactic administration of tamsulosin will be compared to a placebo to evaluate the effectiveness in reducing the incidence of postoperative urinary retention in total hip and knee arthroplasty patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tamsulosin | Experimental | Drug: Tamsulosin0.4 mg daily for five days pre-op through post-op day one (seven total) |
| placebo | Placebo comparator | Drug: PlaceboOne capsule daily for five days pre-op through post-op day one (seven total) |
Who may qualify
- Ages
- 35 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men age 35 or older
- Primary total hip and knee arthroplasty patients (general, spinal, or epidural anesthesia
- No current use (>1 month) of alpha-blockers
- Community ambulator
- Adequate organ and marrow function as defined below:
Key exclusion criteria (10 listed)
- History of radical prostatectomy
- Receiving any other investigational agents
- Revision hip and knee arthroplasty patients
- Severe liver or kidney disease
- Taking strong inhibitors of CYP3A4 (ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir/ritonavir, lopinavir, or conivaptan)
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: Flomax0.4 mg daily | Drug | tamsulosin |
| Placeboone capsule daily | Drug | placebo |
Primary outcome
Number of Patients to Develop Postoperative Urinary Retention (POUR)
Time frame: Postop day 1
Patients who have not developed POUR will have two consecutive, spontaneous urine voids with residual volume of less than 200 mL, as determined by bladder scan or straight catheterization. Patients who do not successfully have the two spontaneous urine voids of less than 200 mL will be considered as having developed POUR. The incidence of POUR will be compared statistically between those taking and not taking tamsulosin at the time of surgery.
5 secondary outcomes
Length of Hospital Stay
Time frame: 1-4 days postoperative
Incidence of Discharge to a Skilled Nursing Facility
Time frame: 1-4 days postoperative
Incidence of Surgical Site Infection
Time frame: Up to two weeks postoperative
Acute Postoperative Pain Medication Dosages
Time frame: Postoperative day 1 to day of discharge (1-4 days on average)
Incidence of Postoperative Complications
Time frame: Up to 31 days postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 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.
Andrew Urquhart, MD principal investigator
University of Michigan, Dept of Orthopaedic Surgery
Manuel Schubert, MD study director
University of Michigan, Dept of Orthopaedic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tamsulosin in people with Postoperative Urinary Retention, run by University of Michigan 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 7 inclusion and 10 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 12 Apr 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. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Apr 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 Patients to Develop Postoperative Urinary Retention (POUR) (time frame: Postop day 1). 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 12 Apr 2019.