- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02486653
Prevention of Post-operative Urinary Retention (POUR)
Pre-operative Tamsulosin for the Prevention of Post-operative Urinary Retention: a Randomized, Double-blind, Placebo-controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Postoperative urinary retention (POUR) complicates up to 30% of general abdominal operations. It results in patient discomfort, embarrassment, interference with therapies, and significant nursing burden. More importantly, urinary retention necessitates use of intermittent catheterization or placement of an indwelling urinary catheter, which exposes the patient to an increased risk of urinary tract infection (UTI), urethral injury, and potentially increased hospital length of stay and cost. For these reasons, a safe and effective intervention for preventing POUR would be highly valuable. Despite such a need, no contemporary studies exist evaluating medications that can be used to prevent POUR in broad general surgery populations. To address this gap, the investigators have designed a prospective, randomized, double-blind, placebo-controlled trial to test the hypothesis that preoperative loading with tamsulosin will prevent POUR in patients undergoing elective, inpatient complex intra-abdominal surgery and thereby lead to improved short-term outcomes.
Tamsulosin is a safe and widely-used selective alpha-1-A adrenergic blocker commonly used for the treatment of lower urinary tract symptoms in men with benign prostatic hypertrophy. It has also been shown to have some benefit in reducing POUR and need for catheterization in men undergoing inguinal hernia repair and other outpatient urologic procedures. This study is a randomized, double-blind, placebo-controlled trial in which patients scheduled for inpatient complex intra-abdominal surgery will be randomized to receive either tamsulosin or placebo for 7 days pre-operatively, and up to several days post-operatively, and then rates of POUR will be compared between the two groups (Aim 1). A retrospective analysis of the data will be used to identify risk factors for POUR and subgroups of patients that would derive the greatest benefit from preoperative tamsulosin (Aim 2). Furthermore, short-term outcomes, including rate of urinary tract infection (UTI) and hospital length of stay, will be compared between the tamsulosin and placebo groups (Aim 3).
Enrolled subjects will be randomized using a blocked, stratified randomization process to either tamsulosin or placebo. Stratification variables include gender, pelvic vs non-pelvic surgery, and International Prostate Symptom Score (IPSS) survey results (which is a measure of baseline lower urinary tract symptoms). After a 7-day treatment period, subjects will undergo surgery as scheduled, and then the assigned treatment will be continued for up to a total of 14 days until the subject either has return of normal voiding function, has required replacement of an indwelling urinary catheter, or is discharged from the hospital.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Wisconsin
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Madison, Wisconsin, United States, 53792
- University of Wisconsin Hospital and Clinics
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
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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:
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Experimental: Tamsulosin
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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:
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Need for Any Intermittent Catheterization Postoperatively as a Binary Outcome
Time Frame: within 0-7 days after surgery
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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
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within 0-7 days after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Need for Replacement of Indwelling Urinary Catheter as a Binary Outcome
Time Frame: within 0-7 days after surgery
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Need for replacement of an IUC after surgery or after initial removal of an IUC that was placed at the time of surgery; replacement of IUC is dictated by the institutional bladder management protocol after requiring the use of straight catheterization for 24 hours
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within 0-7 days after surgery
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Time Until First Spontaneous Void
Time Frame: within 0-7 days after surgery
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time from IUC removal, last intermittent catheterization (if performed in the operating room or post-anesthesia care unit), or departure from the operating room (if no IUC placed intraoperatively) until first spontaneous void
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within 0-7 days after surgery
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Total Number of Intermittent Catheterizations Required Per Subject
Time Frame: within 0-7 days after surgery
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total number of intermittent catheterizations required, as dictated by the institutional bladder management protocol
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within 0-7 days after surgery
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First Post-void Residual Urine Volume
Time Frame: within 0-7 days after surgery
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The post-void residual (PVR) urine volume as measured by bedside hand-held bladder scanning immediately following the first spontaneous void
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within 0-7 days after surgery
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Discharge From Hospital With Indwelling Urinary Catheter
Time Frame: up to 30 days after surgery
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Does the subject have a urinary catheter in place at the time of discharge from the hospital?
This is a binary outcome measure of whether or not the subject is discharged from the hospital with an indwelling urinary catheter in place due to inadequate voiding function.
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up to 30 days after surgery
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Urinary Tract Infection (UTI)
Time Frame: up to 30 days after surgery
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Either a culture-positive UTI prior to discharge from the hospital or subject self-reported clinician-diagnosed UTI occurring within 30 days of surgery
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up to 30 days after surgery
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Hospital Length of Stay in Days
Time Frame: up to 30 days after surgery
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Collected after the participant is discharged from the hospital, total number of consecutive days (including day of surgery) until the participant is discharged from the hospital
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up to 30 days after surgery
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Number of Participants Who Experienced Adverse Events
Time Frame: treatment day 1 (7 days before surgery) until 30 days after surgery
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Adverse events, systematically collected.
Summary results reported here, please refer to Adverse Events section of the results record for detailed reporting.
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treatment day 1 (7 days before surgery) until 30 days after surgery
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Evie H Carchman, MD, University of Wisconsin - Madison School of Medicine and Public Health
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- Buckley BS, Lapitan MC. Drugs for treatment of urinary retention after surgery in adults. Cochrane Database Syst Rev. 2010 Oct 6;(10):CD008023. doi: 10.1002/14651858.CD008023.pub2.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urologic Diseases
- Urination Disorders
- Infections
- Urinary Tract Infections
- Urinary Retention
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Urological Agents
- Adrenergic alpha-1 Receptor Antagonists
- Adrenergic alpha-Antagonists
- Tamsulosin
Other Study ID Numbers
- 2014-1494
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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