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

NCT01568918 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: 11-006704
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Urinary Retention

Outcome Measures

Primary Outcomes (1)

• Incidence of Postoperative Urinary Retention

  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.

  participants will be followed for the duration of the hospital stay, an expected average of 5 days

Secondary Outcomes (1)

• Duration of Postoperative Urinary Retention

  participants will be followed for the duration of the hospital stay, an expected average of 5 days

Study Arms (2)

Tamsulosin

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Tamsulosin hydrochloride DRUG

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

Also known as: Flomax, Flomaxtra, Contiflo XL, Urimax

Tamsulosin

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Clinical Trials website

MeSH Terms

Interventions

Tamsulosin

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Limitations and Caveats

Terminated study due to slow recruitment and enrollment.

Results Point of Contact

• Title: Michelle Clarke, M.D.
• Organization: Mayo Clinic

Clarke.Michelle@mayo.edu

(507) 284-5317

Study Officials

• Michelle Clarke, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 13, 2012
• First Posted: April 2, 2012
• Study Start: May 1, 2012
• Primary Completion: November 21, 2019
• Study Completion: November 21, 2019
• Last Updated: May 30, 2024
• Results First Posted: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)