Prevention of Post-operative Urinary Retention

NCT02486653 | Completed Phase 3 Results DMC

• 1 other identifier: 2014-1494
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if tamsulosin ("FLOMAX") is effective in preventing post-operative urinary retention following abdominal surgery. Post-operative urinary retention is a common post-operative complication, occurring in up to 30% of patients undergoing abdominal surgery. It can be described as the inability to initiate urination or properly empty one's bladder following surgery. It is usually self-limited, but it requires the use of catheterization to empty the bladder in order to prevent further injury to the bladder or kidneys and to relief the discomfort of a full bladder. Tamsulosin is a medication that is commonly used in men with urinary symptoms related to an enlarged prostate. There is some evidence to suggest that it may also potentially be beneficial for preventing post-operative urinary retention. Therefore, in this research study, subjects scheduled for abdominal surgery will be randomly assigned to take either tamsulosin once-daily or placebo once-daily for one week leading up to surgery, and up to several days after surgery. Urinary function will be assessed and compared between these two treatments. The hypothesis is that tamsulosin will reduce the rate of postoperative urinary retention compared to placebo.

Conditions

Urinary Retention; Urinary Tract Infections

Keywords

tamsulosin; randomized controlled trials as topic; double-blind method; random allocation; placebos; Adrenergic alpha-Antagonists; urinary retention; urinary tract infections; urinary catheters; catheter-related infections; postoperative complications

Outcome Measures

Primary Outcomes (1)

• Need for Any Intermittent Catheterization Postoperatively as a Binary Outcome

  need for any intermittent catheterization after leaving the operating room or after initial indwelling urinary catheter (IUC) removal; subjects will be straight catheterized if the subject either 1) reports bladder discomfort, or 2) has a bladder scan for \>500milliliters; or 3) has a post-void residual volume \>500milliliters

  within 0-7 days after surgery

Secondary Outcomes (8)

• Need for Replacement of Indwelling Urinary Catheter as a Binary Outcome

  within 0-7 days after surgery

• Time Until First Spontaneous Void

  within 0-7 days after surgery

• Total Number of Intermittent Catheterizations Required Per Subject

  within 0-7 days after surgery

• First Post-void Residual Urine Volume

  within 0-7 days after surgery

• Discharge From Hospital With Indwelling Urinary Catheter

  up to 30 days after surgery

Study Arms (2)

Tamsulosin

EXPERIMENTAL

Drug: Tamsulosin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Tamsulosin DRUG

Tamsulosin 0.4mg capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively. Outline of schedule: * Day 1-7: tamsulosin 0.4mg in the evening * Day 8: surgery; tamsulosin 0.4mg in the evening if the subject has not yet completed the bladder management protocol * Day 9-14: tamsulosin 0.4mg in the evening until the subject either 1) completes the bladder management protocol (defined by two consecutive voids with post-void residual \<200mL), or 2) has an indwelling urinary catheter replaced, or 3) is discharged from the hospital, whichever occurs first. The minimum number of total doses is 7; the maximum number of total doses is 14. The 14th dose will be the final dose regardless of bladder function.

Also known as: Flomax

Tamsulosin

Placebo DRUG

Placebo capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively. Outline of schedule: * Day 1-7: placebo in the evening * Day 8: surgery; placebo in the evening if the subject has not yet completed the bladder management protocol * Day 9-14: placebo in the evening until the subject either 1) completes the bladder management protocol (defined by two consecutive voids with post-void residual \<200mL), or 2) has an indwelling urinary catheter replaced, or 3) is discharged from the hospital, whichever occurs first. The minimum number of total doses is 7; the maximum number of total doses is 14. The 14th dose will be the final dose regardless of bladder function.

Placebo

Eligibility Criteria

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

You may qualify if:

• English-speaking
• Able to provide informed consent
• Scheduled to undergo an elective, complex intra-abdominal operation with a planned postoperative inpatient stay of at least 1 night

You may not qualify if:

• Less than age 18
• Allergy or contraindication to tamsulosin
• Serious sulfa allergy
• Current use of alpha blocker (alfuzosin, doxazosin, prazosin, silodosin, terazosin, verapamil, tamsulosin) or oral alpha agonist (midodrine), or initiation of one of these medications during the intervention phase of the study will result in subject withdrawal from the study
• Current warfarin use
• Pre-existing indwelling urinary catheter, suprapubic catheter, or urostomy
• End stage renal disease or dialysis-dependence
• Sitting systolic blood pressure in the upper extremity of less than 100mm Hg at time of eligibility screening
• Presence of orthostatic hypotension at the time of eligibility screening (orthostatic hypotension is defined as a drop in systolic blood pressure of 20mm Hg from sitting to standing, or drop in diastolic BP of 10 mm Hg from sitting to standing after 2-3 minutes of standing after being in a sitting position)
• Anticipated inability to take oral medications on post-operative day #0
• Anticipated requirement for indwelling urinary catheter beyond post-operative day #2
• Non-English speaking
• Pregnant or breast-feeding
• Unwillingness to answer all 7 questions on the IPSS (International Prostate Symptom Score) survey
• Lacking capacity to provide informed consent

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Related Publications (11)

• Buckley BS, Lapitan MC. Drugs for treatment of urinary retention after surgery in adults. Cochrane Database Syst Rev. 2010 Oct 6;2010(10):CD008023. doi: 10.1002/14651858.CD008023.pub2.

  PMID: 20927768 BACKGROUND

• Choi S, Awad I. Maintaining micturition in the perioperative period: strategies to avoid urinary retention. Curr Opin Anaesthesiol. 2013 Jun;26(3):361-7. doi: 10.1097/ACO.0b013e32835fc8ba.

  PMID: 23492981 BACKGROUND

• Lo E, Nicolle LE, Coffin SE, Gould C, Maragakis LL, Meddings J, Pegues DA, Pettis AM, Saint S, Yokoe DS. Strategies to prevent catheter-associated urinary tract infections in acute care hospitals: 2014 update. Infect Control Hosp Epidemiol. 2014 May;35(5):464-79. doi: 10.1086/675718. No abstract available.

  PMID: 24709715 BACKGROUND

• Hollingsworth JM, Rogers MA, Krein SL, Hickner A, Kuhn L, Cheng A, Chang R, Saint S. Determining the noninfectious complications of indwelling urethral catheters: a systematic review and meta-analysis. Ann Intern Med. 2013 Sep 17;159(6):401-10. doi: 10.7326/0003-4819-159-6-201309170-00006.

  PMID: 24042368 BACKGROUND

• O'Leary MP. Tamsulosin: current clinical experience. Urology. 2001 Dec;58(6 Suppl 1):42-8; discussion 48. doi: 10.1016/s0090-4295(01)01346-2.

  PMID: 11750250 BACKGROUND

• Madani AH, Aval HB, Mokhtari G, Nasseh H, Esmaeili S, Shakiba M, Shakiba RS, Seyed Damavand SM. Effectiveness of tamsulosin in prevention of post-operative urinary retention: a randomized double-blind placebo-controlled study. Int Braz J Urol. 2014 Jan-Feb;40(1):30-6. doi: 10.1590/S1677-5538.IBJU.2014.01.05.

  PMID: 24642148 BACKGROUND

• Narayan P, Tewari A. A second phase III multicenter placebo controlled study of 2 dosages of modified release tamsulosin in patients with symptoms of benign prostatic hyperplasia. United States 93-01 Study Group. J Urol. 1998 Nov;160(5):1701-6.

  PMID: 9783935 BACKGROUND

• Lepor H. Phase III multicenter placebo-controlled study of tamsulosin in benign prostatic hyperplasia. Tamsulosin Investigator Group. Urology. 1998 Jun;51(6):892-900. doi: 10.1016/s0090-4295(98)00126-5.

  PMID: 9609623 BACKGROUND

• Pummangura N, Kochakarn W. Efficacy of tamsulosin in the treatment of lower urinary tract symptoms (LUTS) in women. Asian J Surg. 2007 Apr;30(2):131-7. doi: 10.1016/S1015-9584(09)60146-9.

  PMID: 17475584 BACKGROUND

• Yaycioglu O, Altan-Yaycioglu R. Intraoperative floppy iris syndrome: facts for the urologist. Urology. 2010 Aug;76(2):272-6. doi: 10.1016/j.urology.2010.01.025. Epub 2010 Mar 28.

  PMID: 20350754 BACKGROUND

• Chang DF, Osher RH, Wang L, Koch DD. Prospective multicenter evaluation of cataract surgery in patients taking tamsulosin (Flomax). Ophthalmology. 2007 May;114(5):957-64. doi: 10.1016/j.ophtha.2007.01.011.

  PMID: 17467530 BACKGROUND

MeSH Terms

Conditions

Urinary Retention; Urinary Tract Infections; Catheter-Related Infections; Postoperative Complications

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Evie Carchman, MD
• Organization: University of Wisconsin - Madison

carchman@surgery.wisc.edu

608-263-2521

Study Officials

• Evie H Carchman, MD

  University of Wisconsin - Madison School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2015
• First Posted: July 1, 2015
• Study Start: August 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: May 2, 2018
• Last Updated: September 25, 2019
• Results First Posted: April 23, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)