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Optimal Duration of Indwelling Urinary Catheter Following Pelvic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01923129
Recruitment Status : Completed
First Posted : August 15, 2013
Results First Posted : February 20, 2019
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
Phillip Fleshner MD, Cedars-Sinai Medical Center

Brief Summary:
There is no general agreement about the optimal duration of postoperative urinary drainage, with relevant literature reporting durations ranging from 1 to 10 days. The available research supporting the routine use of prolonged catheterization is limited and studies investigating early removal following infraperitoneal colorectal surgery have largely been underpowered to form valid practice conclusions. The aim of the investigators study is to determine whether a postoperative colorectal patient can safely have an indwelling catheter removed on postoperative day one (24 hours following surgery) with the addition of a study medication (prazosin), without a statistically significant difference in the incidence of urinary retention compared to the standard, accepted approach of delayed removal (72 hours postoperatively). Patients undergoing laparoscopic and open pelvic colorectal surgery below the peritoneal reflection for both benign and malignant conditions will be randomized into two groups: group one will have the catheter removed on postoperative day 3 (72 hours postoperatively) Group 2 will have a dose of the alpha-blocker prazosin given 6 hours prior to catheter removal and will have the urinary catheter removed on postoperative day 1 (24 hours postoperatively).

Condition or disease Intervention/treatment Phase
Urinary Retention Drug: Prazosin given 6 hours prior to catheter removal in the 24 hour group Not Applicable

Detailed Description:

The available research supporting the routine use of prolonged catheterization is limited and studies investigating early removal following infraperitoneal colorectal surgery have largely been underpowered to form valid practice conclusions. In the era of multimodal recovery algorithms emphasizing early diet advancement, ambulation, and shorter hospital length of stay, unnecessarily prolonging catheterization may interfere with many of these objectives. An indwelling urinary catheter interferes with early patient mobilization potentially lengthening hospitalization and subjects patients to an increased risk of urinary tract infection. A study of 2,355 consecutive patients undergoing primary colorectal cancer resection via laparotomy found an overall prevalence of postoperative urinary retention of 5.5%, however, those patients undergoing low pelvic surgery experience an almost 16% incidence in urinary retention.

Postoperative urinary catheter drainage after infraperitoneal colorectal surgery is commonly practiced, assuming some degree of nerve damage to the superior hypogastric plexus at the sacral promontory or of the nervi erigentes at the pelvic side wall resulting from pelvic dissection, causing transient or permanent dysfunction of the lower urinary tract. It has been believed that this intraoperative damage to the pelvic autonomic nerves may be associated with early postoperative acute urinary retention, and justifies an indwelling urinary catheter for several days following infraperitoneal pelvic surgery. However, there is no general agreement about the optimal duration of postoperative urinary drainage, with relevant literature reporting durations ranging from 1 to 10 days.

Prolonged indwelling urinary catheter has been associated with increased risk of urinary tract infections, with the risk of bacteriuria between 3 and 10% per day when catheterized, with the risk of urinary tract infection increasing by 5% to 10% per catheter day after the second day of catheterization. The incidence of urinary tract infections after anorectal surgery and 5 days of catheterization has been shown to range between 42% and 60%. Higher mortality rates have been reported in hospitalized patients who developed urinary tract infection after indwelling catheterization with the incidence of bacteremia after single catheterization reported to be as high as 8%.

The optimal duration of urinary drainage after infraperitoneal colorectal surgery is unknown. Based on the autonomic mechanisms of micturition in relation to the striated muscle fibers of the external urethral sphincter, alpha blockade has been studied as a potential intervention to reduce the incidence of re-catheterization. A large Cochrane Database reviewed their role in five randomized trials, with four trials favoring alpha blockade over placebo. Furthermore, the side-effect profile of alpha-blockade was low and compared favorably to placebo.

Prior studies have suggested urinary bladder catheter drainage removed on postoperative day one following pelvic surgery may be safe and decrease the incidence of urinary tract infection. However, the study was underpowered to detect meaningful conclusions. A larger study investigating the optimal duration of urinary drainage concluded that removing the catheter one day postoperatively in patients undergoing infraperitoneal colorectal surgery is appropriate, unless a low rectal carcinoma is present or lymph node metastatic disease is present. The investigators wish to further substantiate this evidence and introduce the positive findings associated with alpha-blockade in minimizing the need for re-catheterization.

The investigators therefore propose a prospective, controlled randomized trial to compare the effects of 1 day's transurethral catheterization after infraperitoneal surgery with an alpha blockade medication compared to those of 3 days of catheterization, with acute urinary retention as a primary endpoint.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Study Investigating Optimal Duration of Indwelling Urinary Catheter Following Infraperitoneal Colorectal Surgery and Role of Postoperative Alpha Blockade
Actual Study Start Date : November 30, 2012
Actual Primary Completion Date : November 22, 2017
Actual Study Completion Date : November 22, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 24 hour postop catheter removal
group will receive the study medication prazosin ( 1 mg PO) 6 hours prior to catheter discontinuation (24 hours postoperatively)
Drug: Prazosin given 6 hours prior to catheter removal in the 24 hour group
Prazosin given orally (1 mg) 6 hours prior to catheter removal (hour 18 postoperatively)
Other Names:
  • Minipress
  • Vasoflex
  • Pressin
  • Hypovase

No Intervention: 72 hour postoperative catheter removal
catheter removed on postoperative day 3 (72 hours postoperatively)



Primary Outcome Measures :
  1. Number of Participants With Acute Urinary Retention [ Time Frame: Postoperative day 1 or postpoperative 3 depending on group randomization ]
    Acute urinary retention will be defined as catheter discontinuation with inability to void 6 hours post-removal, or void with post-void residual greater than 200 cc of urine.


Secondary Outcome Measures :
  1. Number of Participants With a Symptomatic Urinary Tract Infection [ Time Frame: During 1 week of hospitalization (prior to discharge) ]
    Urinary tract infection defined as symptomatic urinary complaints such as dysuria, with urinalysis consistent with infection.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form;
  2. Males or females, >18 years of age inclusive at the time of study screening;
  3. American Society of Anesthesiologists (ASA) Class I-III;
  4. Infraperitoneal colorectal surgery (open and/or laparoscopic);
  5. Elective Surgery

Exclusion Criteria:

  1. Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures;
  2. Children <18;
  3. No perioperative antibiotics;
  4. Past or current urinary tract malignancy;
  5. Urinary catheter inserted before surgery;
  6. Chronic kidney insufficiency with Creatinine> 2
  7. Diagnosis of benign prostatic hyperplasia
  8. Chronic urinary infections
  9. Neurogenic bladder
  10. History of enterovesical fistula
  11. Pregnancy
  12. Prior surgery of the lower urinary tract
  13. Epidural
  14. Perioperative ureteral stents

After randomization:

  1. Catheter pulled out inadvertently;
  2. Postoperative complications requiring prolonged monitoring of urine output
  3. Postoperative complications requiring early reoperation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01923129


Locations
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United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
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Principal Investigator: Phillip Fleshner, MD Cedars-Sinai Medical Center
  Study Documents (Full-Text)

Documents provided by Phillip Fleshner MD, Cedars-Sinai Medical Center:
Study Protocol  [PDF] November 30, 2012
Statistical Analysis Plan  [PDF] November 30, 2012

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Phillip Fleshner MD, Widjaja Chair in Colorectal Surgery, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01923129    
Other Study ID Numbers: 00029210
First Posted: August 15, 2013    Key Record Dates
Results First Posted: February 20, 2019
Last Update Posted: February 20, 2019
Last Verified: January 2019
Keywords provided by Phillip Fleshner MD, Cedars-Sinai Medical Center:
indwelling catheter
foley
duration
Additional relevant MeSH terms:
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Urinary Retention
Urination Disorders
Urologic Diseases
Prazosin
Antihypertensive Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs