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OpenTrials
Completed

NCT Number: NCT02919436

Decreasing Rates of Intraurethral Catheterization Postoperatively in Spine Surgery

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

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Key information

Age range

50 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Maine Medical Center

Portland, Maine, 04102, United States

About this study

Postoperative urinary retention (POUR) is a common complication following certain surgical operations. While much is known about the innervation and neural regulation of bladder emptying and storage, the cause of urinary retention after surgery is not fully understood. Early research has indicated that a small dose of tamsulosin (Flomax®), a commonly used medication approved to treat urinary symptoms in men with benign prostatic hypertrophy, may reduce the incidence of POUR. Urinary retention is a prevalent issue in patients undergoing spinal surgery, leading to patient discomfort and prolonged length of stay. We hypothesize that the use of perioperative tamsulosin in patients undergoing spinal surgery will decrease the incidence of POUR.

The study is a prospective, double-blind, randomized, placebo-controlled trial. Subjects will be randomized 1:1 to receive either oral tamsulosin 0.4 mg or placebo, taken once each evening, beginning 5 days prior to surgery and continuing through the first postoperative day. The primary endpoint is met when the patient is able to spontaneously empty their bladder post-operatively, or needs to be catheterized with either a straight or indwelling urinary catheter for post-operative urinary retention, whichever occurs first.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Tamsulosin

Drug

Active drug

Other names: Flomax, Flomaxtra, Contiflo XL, Urimax

Placebo

Drug

Lactose-filled capsules identical to active drug

Primary outcomes

  1. Number of Patients Who Undergo Postoperative Catheterization for Urinary Retention

    Time frame: Within 2 days after surgery

    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.

Secondary outcomes

  1. Length of Stay

    Time frame: 0-7 days after surgery

    Length of hospital stay

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

    Time frame: Within 2 days after surgery

    Was post-void residual greater than 50 cc when measured at the preoperative office visit associated with postoperative urinary retention?

Sponsors and collaborators

Lead sponsor

Anand Rughani, MD

Other

Collaborators

  • MaineHealth

Registry information

Acronym: DRIPS

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Sep 29, 2016
Registry last updated
Feb 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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