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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Michelle J. Clarke, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01568918
First received: March 13, 2012
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Postoperative Urinary Retention
Drug: Tamsulosin hydrochloride
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: The Use of an Uroselective Alpha-1-antagonist to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Incidence of postoperative urinary retention [ Time Frame: participants will be followed for the duration of the hospital stay, an expected average of 5 days ] [ Designated as safety issue: No ]

    Post operative urinary retention (POUR) will be defined as any of the following:

    1) Estimated post-void residual (PVR) volume of urine greater than or equal to 300 mL; 2) Estimated retention urine volume of greater than or equal to 500 mL in patients unable to void; 3) Patients experiencing discomfort or distension and unable to void with lesser residual urine volume than 500 ml.



Secondary Outcome Measures:
  • Duration of postoperative urinary retention [ Time Frame: participants will be followed for the duration of the hospital stay, an expected average of 5 days ] [ Designated as safety issue: No ]
    The neurosurgical team will decide if an indwelling urinary catheter will be used. Time of indwelling catheter removal after surgery will serve as time zero for beginning calculation of postoperative urinary retention duration if the patient later requires in and out straight catheterization. For patients without an indwelling catheter, the time patients leave the operating room will serve as time zero. Urinary retention will be considered resolved after two consecutive post-void residual urine scans have demonstrated less than 300 ml residual urine volume in a patient spontaneously voiding.


Estimated Enrollment: 350
Study Start Date: May 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tamsulosin
Participants randomized to this arm will receive 0.4 mg/day tamsulosin hydrochloride from 5 days prior to the operation until hospital discharge.
Drug: Tamsulosin hydrochloride
Participants will receive 0.4 mg/day tamsulosin hydrochloride from 5 days prior to the operation until hospital discharge.
Other Names:
  • Flomax
  • Flomaxtra
  • Contiflo XL
  • Urimax
Placebo Comparator: 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.
Other: Placebo
The placebo capsule matching the active study drug will be given daily from 5 days prior to the operation until hospital discharge.

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.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01568918

Contacts
Contact: Steven D Thalacker, RN 507-255-7906 thals@mayo.edu

Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Steve Thalacker, RN    507-255-7906    thals@mayo.edu   
Contact: Sandra Twaites    507-284-5775    twaites.sandra@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Michelle Clarke, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Michelle J. Clarke, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01568918     History of Changes
Other Study ID Numbers: 11-006704
Study First Received: March 13, 2012
Last Updated: January 28, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Urinary Retention
Urination Disorders
Urologic Diseases
Tamsulosin
Adrenergic Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on October 20, 2014