Optimal Duration of Indwelling Urinary Catheter Following Pelvic Surgery

NCT01923129 | Completed Results DMC

• 1 other identifier: 00029210
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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).

Conditions

Urinary Retention

Keywords

indwelling catheter; foley; duration

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Acute Urinary Retention

  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.

  Postoperative day 1 or postpoperative 3 depending on group randomization

Secondary Outcomes (1)

• Number of Participants With a Symptomatic Urinary Tract Infection

  During 1 week of hospitalization (prior to discharge)

Study Arms (2)

24 hour postop catheter removal

EXPERIMENTAL

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

72 hour postoperative catheter removal

NO INTERVENTION

catheter removed on postoperative day 3 (72 hours postoperatively)

Interventions

Prazosin given 6 hours prior to catheter removal in the 24 hour group DRUG

Prazosin given orally (1 mg) 6 hours prior to catheter removal (hour 18 postoperatively)

Also known as: Minipress, Vasoflex, Pressin, Hypovase

24 hour postop catheter removal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures;
• Children \<18;
• No perioperative antibiotics;
• Past or current urinary tract malignancy;
• Urinary catheter inserted before surgery;
• Chronic kidney insufficiency with Creatinine\> 2
• Diagnosis of benign prostatic hyperplasia
• Chronic urinary infections
• Neurogenic bladder
• History of enterovesical fistula
• Pregnancy
• Prior surgery of the lower urinary tract
• Epidural
• Perioperative ureteral stents
• After randomization:

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Publications (2)

• Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.

  PMID: 34184246 DERIVED

• Patel DN, Felder SI, Luu M, Daskivich TJ, N Zaghiyan K, Fleshner P. Early Urinary Catheter Removal Following Pelvic Colorectal Surgery: A Prospective, Randomized, Noninferiority Trial. Dis Colon Rectum. 2018 Oct;61(10):1180-1186. doi: 10.1097/DCR.0000000000001206.

  PMID: 30192326 DERIVED

MeSH Terms

Conditions

Urinary Retention

Interventions

Population Groups; Prazosin

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Phillip Fleshner
• Organization: Cedars Sinai Medical Center

Phillip.Fleshner@cshs.org

(310) 289-9224

Study Officials

• Phillip Fleshner, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Widjaja Chair in Colorectal Surgery

Study Record Dates

• First Submitted: July 29, 2013
• First Posted: August 15, 2013
• Study Start: November 30, 2012
• Primary Completion: November 22, 2017
• Study Completion: November 22, 2017
• Last Updated: February 20, 2019
• Results First Posted: February 20, 2019

Record last verified: 2019-01

Locations

US (1)