Post-operative Urinary RetentionPhase 4DRIPSNCT02919436
Decreasing Rates of Intraurethral Catheterization Postoperatively in Spine Surgery
A Phase 4 study testing Tamsulosin in people with Post-operative Urinary Retention, run by Anand Rughani, MD at 1 site in United States.
Trial summary
Randomization (1:1) of male patients, over age 50, undergoing elective spine surgery to tamsulosin versus a placebo. Read more about this study
- Who is it for?
- Ages 50 to 85 years, men only
- Conditions the study is for
- Post-operative 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
- 610 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Nov 2020
- Phase
- Phase 4
- 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 50 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patient age 50 - 85 years
- Undergoing elective spine surgery at least 5 days after enrollment
- Preop visit done at office practice
Who cannot join
- Currently on tamsulosin or other alpha-adrenergic blocking drug
- Allergy to tamsulosin
- Allergy to lactose
- Serious or life-threatening allergy to sulfa drugs
- Emergent procedure
- History of spinal trauma, spinal infection or spinal cord tumor
Show all 12Show fewer
- Pre-existing indwelling urinary catheter
- History of orthostatic hypotension or current orthostatic hypotension
- History of prostate, urethral or bladder surgery
- Renal failure
- Non-English speaking
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Randomization (1:1) of male patients, over age 50, undergoing elective spine surgery to tamsulosin versus a placebo.
Read the detailed description
Postoperative urinary retention (POUR) is a common complication following certain surgical operations. While much is known about the innervation and neural regulation of bladder emptying and storage, the cause of urinary retention after surgery is not fully understood. Early research has indicated that a small dose of tamsulosin (Flomax®), a commonly used medication approved to treat urinary symptoms in men with benign prostatic hypertrophy, may reduce the incidence of POUR. Urinary retention is a prevalent issue in patients undergoing spinal surgery, leading to patient discomfort and prolonged length of stay. We hypothesize that the use of perioperative tamsulosin in patients undergoing spinal surgery will decrease the incidence of POUR.
The study is a prospective, double-blind, randomized, placebo-controlled trial. Subjects will be randomized 1:1 to receive either oral tamsulosin 0.4 mg or placebo, taken once each evening, beginning 5 days prior to surgery and continuing through the first postoperative day. The primary endpoint is met when the patient is able to spontaneously empty their bladder post-operatively, or needs to be catheterized with either a straight or indwelling urinary catheter for post-operative urinary retention, whichever occurs first.
- Conditions
- Post-operative 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, Flomaxtra, Contiflo XL, Urimax
Active drug
PlaceboDrug
Lactose-filled capsules identical to active drug
| Study group | Role | What they receive |
|---|---|---|
| Tamsulosin | Experimental | Subjects in this arm will receive tamsulosin 0.4 mg/day for five days prior to surgery and two days after surgery. Receives: Drug: Tamsulosin |
| Placebo | Placebo comparator | Subjects in this arm will receive a placebo capsule identical in appearance to the tamsulosin capsule, for five days prior to surgery and two days after surgery. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Who Undergo Postoperative Catheterization for Urinary Retention
Postoperative urinary retention was defined as the need for any postoperative urinary catheterization for acute retention. Per hospital protocol, failure to void 6 hours after surgery or development of bladder discomfort required bladder scan. If bladder volume exceeded 300 cc, catheterization was performed.
Measured: Within 2 days after surgery
Secondary outcomes (2)
Length of Stay
Length of hospital stay
Measured: 0-7 days after surgery
Number of Participants With or Without Postoperative Urinary Retention Based on Preoperative Post-void Residual
Was post-void residual greater than 50 cc when measured at the preoperative office visit associated with postoperative urinary retention?
Measured: Within 2 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study startMar 2016
- Primary completionJan 2020
- Study completionNov 2020
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.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 610 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anand Rughani, MD
- Sponsor type
- University, hospital or other
- Collaborators
- MaineHealth
- Responsible party
- Sponsor-investigator, Anand Rughani, MD, MaineHealth
- Investigators
- Anand Rughani, MD, Principal investigator, MaineHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02919436
- Sponsor's protocol ID
- IRB #4742
- Acronym
- DRIPS
- Status last verified
- Jan 2022
- First submitted
- 28 Sep 2016
- Last updated
- 17 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing Rates of Intraurethral Catheterization Postoperatively in Spine Surgery
- ClinicalTrials.gov ID
- NCT02919436
- Acronym / sponsor ID
- DRIPS / IRB #4742
- Conditions
- Post-operative Urinary Retention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 610 participants (actual)
- Lead sponsor
- Anand Rughani, MDUniversity, hospital or other
- Collaborators
- MaineHealth
- Study start
- Mar 2016
- Primary completion
- Jan 2020 (actual)
- Study completion
- Nov 2020 (actual)
- First posted
- 29 Sep 2016 (estimated)
- Results
- Posted 17 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomization (1:1) of male patients, over age 50, undergoing elective spine surgery to tamsulosin versus a placebo.
Detailed description
Postoperative urinary retention (POUR) is a common complication following certain surgical operations. While much is known about the innervation and neural regulation of bladder emptying and storage, the cause of urinary retention after surgery is not fully understood. Early research has indicated that a small dose of tamsulosin (Flomax®), a commonly used medication approved to treat urinary symptoms in men with benign prostatic hypertrophy, may reduce the incidence of POUR. Urinary retention is a prevalent issue in patients undergoing spinal surgery, leading to patient discomfort and prolonged length of stay. We hypothesize that the use of perioperative tamsulosin in patients undergoing spinal surgery will decrease the incidence of POUR.
The study is a prospective, double-blind, randomized, placebo-controlled trial. Subjects will be randomized 1:1 to receive either oral tamsulosin 0.4 mg or placebo, taken once each evening, beginning 5 days prior to surgery and continuing through the first postoperative day. The primary endpoint is met when the patient is able to spontaneously empty their bladder post-operatively, or needs to be catheterized with either a straight or indwelling urinary catheter for post-operative urinary retention, whichever occurs first.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tamsulosin | Experimental | Drug: TamsulosinSubjects in this arm will receive tamsulosin 0.4 mg/day for five days prior to surgery and two days after surgery. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects in this arm will receive a placebo capsule identical in appearance to the tamsulosin capsule, for five days prior to surgery and two days after surgery. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male patient age 50 - 85 years
- Undergoing elective spine surgery at least 5 days after enrollment
- Preop visit done at office practice
Key exclusion criteria (12 listed)
- Currently on tamsulosin or other alpha-adrenergic blocking drug
- Allergy to tamsulosin
- Allergy to lactose
- Serious or life-threatening allergy to sulfa drugs
- Emergent procedure
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: Flomax, Flomaxtra, Contiflo XL, UrimaxActive drug | Drug | Tamsulosin |
| PlaceboLactose-filled capsules identical to active drug | Drug | Placebo |
Primary outcome
Number of Patients Who Undergo Postoperative Catheterization for Urinary Retention
Time frame: Within 2 days after surgery
Postoperative urinary retention was defined as the need for any postoperative urinary catheterization for acute retention. Per hospital protocol, failure to void 6 hours after surgery or development of bladder discomfort required bladder scan. If bladder volume exceeded 300 cc, catheterization was performed.
2 secondary outcomes
Length of Stay
Time frame: 0-7 days after surgery
Number of Participants With or Without Postoperative Urinary Retention Based on Preoperative Post-void Residual
Time frame: Within 2 days after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- 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.
Anand Rughani, MD principal investigator
MaineHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tamsulosin in people with Post-operative Urinary Retention, run by Anand Rughani, MD 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 12 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 17 Feb 2022. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 17 Feb 2022). 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 Who Undergo Postoperative Catheterization for Urinary Retention (time frame: Within 2 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 17 Feb 2022.