MedDataX Logo

Uroselective Alpha-1-Antagonist to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery

NCT ID: NCT07174349

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2028-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Urinary Retention Postoperative

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment Group

Neurosurgical patients undergoing decompressive laminectomy and/or spinal fusion who will receive uroselective alpha-1-adrenergic receptor antagonist Tamsulosin

Group Type EXPERIMENTAL

Uroselective alpha-1-adrenergic receptor antagonist

Intervention Type DRUG

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)

Control Group

Neurosurgical patients undergoing decompressive laminectomy and/or spinal fusion who will receive a placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Subjects will receive placebo beginning 5 days prior to surgery and for the duration of the postoperative hospital stay (approximately 8-12 days)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Uroselective alpha-1-adrenergic receptor antagonist

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)

Intervention Type DRUG

Placebo

Subjects will receive placebo beginning 5 days prior to surgery and for the duration of the postoperative hospital stay (approximately 8-12 days)

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Tamsulosin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Cervical Laminectomy
* Cervical Posterior Fusion
* Cervical Anterior/Posterior Fusion
* Lumbar Laminectomy
* Lumbar Posterolateral Fusion
* Lumbar Interbody Fusion

Exclusion Criteria

* Cervical Anterior Discectomy and Fusion
* Cervical Anterior Corpectomy
* Cervical Posterior Discectomy
* Cervical Foraminotomy
* Lumbar Discectomy (METRx or Open)
* Lumbar Foraminotomy
* 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)
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Michelle J. Clarke

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michelle Clarke, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Neurologic Surgery Research Team

Role: CONTACT

Phone: 507-422-5673

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Neurologic Surgery Research Team

Role: primary

Related Links

Access external resources that provide additional context or updates about the study.

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

24-005742

Identifier Type: -

Identifier Source: org_study_id