Decreasing Rates of Intraurethral Catheterization Postoperatively in Spine Surgery

NCT02919436 | Completed Phase 4 Results DMC

• 1 other identifier: IRB #4742
• Study Type: interventional
• Target: 610
• Locations: 1 country
• Sites: 1

Brief Summary

Randomization (1:1) of male patients, over age 50, undergoing elective spine surgery to tamsulosin versus a placebo.

Conditions

Post-operative Urinary Retention

Outcome Measures

Primary Outcomes (1)

• Number of Patients Who Undergo Postoperative Catheterization for Urinary Retention

  Postoperative urinary retention was defined as the need for any postoperative urinary catheterization for acute retention. Per hospital protocol, failure to void 6 hours after surgery or development of bladder discomfort required bladder scan. If bladder volume exceeded 300 cc, catheterization was performed.

  Within 2 days after surgery

Secondary Outcomes (2)

• Length of Stay

  0-7 days after surgery

• Number of Participants With or Without Postoperative Urinary Retention Based on Preoperative Post-void Residual

  Within 2 days after surgery

Study Arms (2)

Tamsulosin

EXPERIMENTAL

Subjects in this arm will receive tamsulosin 0.4 mg/day for five days prior to surgery and two days after surgery.

Drug: Tamsulosin

Placebo

PLACEBO COMPARATOR

Subjects in this arm will receive a placebo capsule identical in appearance to the tamsulosin capsule, for five days prior to surgery and two days after surgery.

Drug: Placebo

Interventions

Tamsulosin DRUG

Active drug

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

Tamsulosin

Placebo DRUG

Lactose-filled capsules identical to active drug

Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male patient age 50 - 85 years
• Undergoing elective spine surgery at least 5 days after enrollment
• Preop visit done at office practice

You may not qualify if:

• Currently on tamsulosin or other alpha-adrenergic blocking drug
• Allergy to tamsulosin
• Allergy to lactose
• Serious or life-threatening allergy to sulfa drugs
• Emergent procedure
• History of spinal trauma, spinal infection or spinal cord tumor
• Pre-existing indwelling urinary catheter
• History of orthostatic hypotension or current orthostatic hypotension
• History of prostate, urethral or bladder surgery
• Renal failure
• Non-English speaking
• Unable to provide informed consent

Sponsors & Collaborators

• Anand Rughani, MD: lead
• MaineHealth: collaborator

Study Sites (1)

Maine Medical Center

Portland, Maine, 04102, United States

Location

MeSH Terms

Interventions

Tamsulosin

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Anand Rughani
• Organization: Maine Medical Center

arughani@mmc.org

207-885-0011

Study Officials

• Anand Rughani, MD

  MaineHealth

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Neurosurgeon

Study Record Dates

• First Submitted: September 28, 2016
• First Posted: September 29, 2016
• Study Start: March 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: November 1, 2020
• Last Updated: February 17, 2022
• Results First Posted: February 17, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)