Use of Tamsulosin to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery

NCT ID: NCT01568918

Last Updated: 2024-05-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2019-11-21

Brief Summary

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 (UTIs) and prolonged hospital stays. With the addition of Tamsulosin, the investigators 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.

Detailed Description

Decompressive laminectomy and spinal fusion procedures are among the most common neurosurgical procedures performed. Postoperative urinary retention (POUR) is a frequent complication of such surgeries and impacts a large proportion of this population resulting in multiple intermittent bladder catheterizations for bladder decompression, increased incidence of bacteremia, increased incidence of UTIs, and prolonged hospital stays. Use of a uroselective alpha-1-adrenergic receptor antagonist, such as tamsulosin, in the perioperative period (medication started five days prior to surgery and taken until hospital discharge) could reduce both the incidence and duration of postoperative urinary retention, resulting in shorter hospital stays and decreased healthcare costs.

Conditions

Postoperative Urinary Retention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Tamsulosin

Participants randomized to this arm will receive 0.4 mg/day tamsulosin hydrochloride from 5 days prior to the operation until hospital discharge.

Group Type: EXPERIMENTAL

Tamsulosin hydrochloride

Intervention Type: DRUG

Participants will receive 0.4 mg/day tamsulosin hydrochloride from 5 days prior to the operation until hospital discharge.

Placebo

Participants randomized to this arm will receive a daily placebo capsule matching the active study drug from 5 days prior to the operation until hospital discharge.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

The placebo capsule matching the active study drug will be given daily from 5 days prior to the operation until hospital discharge.

Interventions

Tamsulosin hydrochloride

Participants will receive 0.4 mg/day tamsulosin hydrochloride from 5 days prior to the operation until hospital discharge.

Intervention Type: DRUG

Placebo

The placebo capsule matching the active study drug will be given daily from 5 days prior to the operation until hospital discharge.

Intervention Type: OTHER

Other Intervention Names

Flomax; Flomaxtra; Contiflo XL; Urimax

Eligibility Criteria

Inclusion Criteria

• ≥ 35 years (Males & Females)
• Cervical Laminectomy
• Cervical Posterior Fusion
• Cervical Anterior/Posterior Fusion
• Lumbar Laminectomy
• Lumbar Posterolateral Fusion
• Lumbar Interbody Fusion

Exclusion Criteria

• < 35 years
• 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
• Patients with history of allergy or sensitivity to tamsulosin or other alpha-antagonist (alfuzosin, doxazosin, prazosin, terazosin, tamsulosin, and phenoxybenzamine)
• 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 (ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir/ritonavir, lopinavir/ritonavir, and conivaptan)
• Patients with a mental disability
• Prisoners

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Michelle J. Clarke

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michelle Clarke, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://clinicaltrials.gov

Clinical Trials website

Other Identifiers

11-006704

Identifier Type: -

Identifier Source: org_study_id