Urinary Retention PostoperativePhase 4NCT07174349
Uroselective Alpha-1-Antagonist to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery
A Phase 4 study testing Uroselective alpha-1-adrenergic receptor antagonist in people with Urinary Retention Postoperative, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to see if the use of tamsulosin can decrease both the incidence and duration of urinary retention, as well as hospital length of stay following spine surgery. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Urinary Retention Postoperative
- What is being tested?
- Uroselective alpha-1-adrenergic receptor antagonist
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 31 Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cervical Laminectomy
- Cervical Posterior Fusion
- Cervical Anterior/Posterior Fusion
- Lumbar Laminectomy
- Lumbar Posterolateral Fusion
- Lumbar Interbody Fusion
Who cannot join
- Cervical Anterior Discectomy and Fusion
- Cervical Anterior Corpectomy
- Cervical Posterior Discectomy
- Cervical Foraminotomy
- Lumbar Discectomy (METRx or Open)
- Lumbar Foraminotomy
Show all 17Show fewer
- Lumbar Anterior Fusion
- Myelopathy with bladder dysfunction
- Patients currently taking an alpha-antagonist
- o The following drugs are alpha antagonists: alfuzosin, doxazosin, prazosin, terazosin, tamsulosin, and phenoxybenzamine.
- Patients with history of allergy or sensitivity to tamsulosin or other alpha-antagonist
- History of prostatectomy or urologic surgery involving the bladder or urethra
- Severe liver disease or end-stage renal disease
- Patients taking strong inhibitors of CYP3A4
- o The following drugs are strong inhibitors of CYP3A4: ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir/ritonavir, lopinavir/ritonavir, and conivaptan.
- Mental disability or prisoner
- Pregnancy (for anesthesia purposes)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Neurologic Surgery Research Team contact
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Neurologic Surgery Research Team, 507-422-5673
Michelle J Clarke, MD, PhD
About this study
Official title: The Use of an Uroselective Alpha-1-antagonist to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery
The purpose of this research is to see if the use of tamsulosin can decrease both the incidence and duration of urinary retention, as well as hospital length of stay following spine surgery.
Read the detailed description
Postoperative urinary retention is a frequent complication of spinal surgeries and impacts a large portion of this population which results in increased morbidity as a result of increased number of catheterizations, urinary tract infections and prolonged hospital stays. With the addition of Tamsulosin, we would anticipate a reduction in the incidence and duration of postoperative urinary retention and therefore a reduction in morbidity related to treatment of urinary retention as well as shortened hospital stays.
- Conditions
- Urinary Retention Postoperative
- Being tested
- Uroselective alpha-1-adrenergic receptor antagonist, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uroselective alpha-1-adrenergic receptor antagonistDrug
Also called Tamsulosin
Subjects will receive Tamsulosin (0.4 mg daily) beginning 5 days prior to surgery and for the duration of the postoperative hospital stay (approximately 8-12 days)
PlaceboOther
Subjects will receive placebo beginning 5 days prior to surgery and for the duration of the postoperative hospital stay (approximately 8-12 days)
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Neurosurgical patients undergoing decompressive laminectomy and/or spinal fusion who will receive uroselective alpha-1-adrenergic receptor antagonist Tamsulosin Receives: Drug: Uroselective alpha-1-adrenergic receptor antagonist |
| Control Group | Placebo comparator | Neurosurgical patients undergoing decompressive laminectomy and/or spinal fusion who will receive a placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of incidences of POUR (Postoperative urinary retention)
Total number of incidences of POUR (Postoperative urinary retention). POUR is defined as any of the following: estimated post-void residual (PVR) volume of urine greater than or equal to 300 mL; estimated retention urine volume of greater than or equal to 500 mL in patients unable to void; or patients experiencing discomfort or distension and unable to void with lesser residual urine volume than 500 ml.
Measured: Post-operatively through end of hospital stay, approximately 8-12 days
Secondary outcomes (4)
Duration of POUR (Postoperative urinary retention)
Duration subjects experience postoperative urinary retention, reported in days
Measured: Post-operatively through end of hospital stay, approximately 8-12 days
Number of intermittent catheterizations in those with urinary retention
Total number of catheterizations performed in subjects who experience urinary retention
Measured: Post-operatively through end of hospital stay, approximately 8-12 days
Incidence of UTI (urinary tract infection)
Number of subjects to be diagnosed with a UTI (urinary tract infection) post-operatively
Measured: Post-operatively through end of hospital stay, approximately 8-12 days
Duration of hospital stay
Total length of time subjects remain inpatient post-procedure, reported in days.
Measured: Post-operatively through end of hospital stay, approximately 8-12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start1 Oct 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Retention PostoperativeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle J. Clarke, Mayo Clinic
- Investigators
- Michelle Clarke, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174349
- Sponsor's protocol ID
- 24-005742
- Status last verified
- Jun 2026
- First submitted
- 12 Sep 2025
- Last updated
- 29 Jun 2026
- Results posted
- No
- 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 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of an Uroselective Alpha-1-antagonist to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery
- ClinicalTrials.gov ID
- NCT07174349
- Acronym / sponsor ID
- 24-005742
- Conditions
- Urinary Retention Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 15 Sep 2025 (actual)
- 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 this research is to see if the use of tamsulosin can decrease both the incidence and duration of urinary retention, as well as hospital length of stay following spine surgery.
Detailed description
Postoperative urinary retention is a frequent complication of spinal surgeries and impacts a large portion of this population which results in increased morbidity as a result of increased number of catheterizations, urinary tract infections and prolonged hospital stays. With the addition of Tamsulosin, we would anticipate a reduction in the incidence and duration of postoperative urinary retention and therefore a reduction in morbidity related to treatment of urinary retention as well as shortened hospital stays.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: Uroselective alpha-1-adrenergic receptor antagonistNeurosurgical patients undergoing decompressive laminectomy and/or spinal fusion who will receive uroselective alpha-1-adrenergic receptor antagonist Tamsulosin |
| Control Group | Placebo comparator | Other: PlaceboNeurosurgical patients undergoing decompressive laminectomy and/or spinal fusion who will receive a placebo |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Cervical Laminectomy
- Cervical Posterior Fusion
- Cervical Anterior/Posterior Fusion
- Lumbar Laminectomy
- Lumbar Posterolateral Fusion
Key exclusion criteria (17 listed)
- Cervical Anterior Discectomy and Fusion
- Cervical Anterior Corpectomy
- Cervical Posterior Discectomy
- Cervical Foraminotomy
- Lumbar Discectomy (METRx or Open)
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 |
|---|---|---|
| Uroselective alpha-1-adrenergic receptor antagonistAlso: TamsulosinSubjects will receive Tamsulosin (0.4 mg daily) beginning 5 days prior to surgery and for the duration of the postoperative hospital stay (approximately 8-12 days) | Drug | Treatment Group |
| PlaceboSubjects will receive placebo beginning 5 days prior to surgery and for the duration of the postoperative hospital stay (approximately 8-12 days) | Other | Control Group |
Primary outcome
Number of incidences of POUR (Postoperative urinary retention)
Time frame: Post-operatively through end of hospital stay, approximately 8-12 days
Total number of incidences of POUR (Postoperative urinary retention). POUR is defined as any of the following: estimated post-void residual (PVR) volume of urine greater than or equal to 300 mL; estimated retention urine volume of greater than or equal to 500 mL in patients unable to void; or patients experiencing discomfort or distension and unable to void with lesser residual urine volume than 500 ml.
4 secondary outcomes
Duration of POUR (Postoperative urinary retention)
Time frame: Post-operatively through end of hospital stay, approximately 8-12 days
Number of intermittent catheterizations in those with urinary retention
Time frame: Post-operatively through end of hospital stay, approximately 8-12 days
Incidence of UTI (urinary tract infection)
Time frame: Post-operatively through end of hospital stay, approximately 8-12 days
Duration of hospital stay
Time frame: Post-operatively through end of hospital stay, approximately 8-12 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Neurologic Surgery Research Team contact
Michelle Clarke, MD, PhD principal investigator
Mayo Clinic
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 Uroselective alpha-1-adrenergic receptor antagonist in people with Urinary Retention Postoperative, run by Mayo Clinic 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 6 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 29 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neurologic Surgery Research Team (507-422-5673), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of incidences of POUR (Postoperative urinary retention) (time frame: Post-operatively through end of hospital stay, approximately 8-12 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 29 Jun 2026.