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Urinary RetentionNCT01923129

Optimal Duration of Indwelling Urinary Catheter Following Pelvic Surgery

A study testing Prazosin given 6 hours prior to catheter removal in the 24 hour group in people with Urinary Retention, run by Cedars-Sinai Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Urinary Retention
What is being tested?
Prazosin given 6 hours prior to catheter removal in the 24 hour group
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
142 participants
Where
1 siteUnited States
Study dates
30 Nov 2012to 22 Nov 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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:
  • Catheter pulled out inadvertently;
  • Postoperative complications requiring prolonged monitoring of urine output
  • Postoperative complications requiring early reoperation

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

Other trials in United States

About this study

Official title: Prospective Study Investigating Optimal Duration of Indwelling Urinary Catheter Following Infraperitoneal Colorectal Surgery and Role of Postoperative Alpha Blockade

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).

Read the 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.

Being tested
Prazosin given 6 hours prior to catheter removal in the 24 hour group
Keywords
indwelling catheter, foley, duration
Medical subject headings
Urinary Retention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prazosin given 6 hours prior to catheter removal in the 24 hour groupDrug

    Also called Minipress, Vasoflex, Pressin, Hypovase

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

Study groups in NCT01923129
Study groupRoleWhat they receive
24 hour postop catheter removalExperimentalgroup will receive the study medication prazosin ( 1 mg PO) 6 hours prior to catheter discontinuation (24 hours postoperatively)
Receives: Drug: Prazosin given 6 hours prior to catheter removal in the 24 hour group
72 hour postoperative catheter removalNo interventioncatheter removed on postoperative day 3 (72 hours postoperatively)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Postoperative day 1 or postpoperative 3 depending on group randomization

Secondary outcomes (1)
  1. Number of Participants With a Symptomatic Urinary Tract Infection

    Urinary tract infection defined as symptomatic urinary complaints such as dysuria, with urinalysis consistent with infection.

    Measured: During 1 week of hospitalization (prior to discharge)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2013 (estimated)
  2. Study start30 Nov 2012
  3. Primary completion22 Nov 2017
  4. Study completion22 Nov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
142 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01923129
Sponsor's protocol ID
00029210
Status last verified
Jan 2019
First submitted
29 Jul 2013
Last updated
20 Feb 2019
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 34184246
  • 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.

    PubMed 30192326

Questions about this trial

What is this clinical trial studying?

A study testing Prazosin given 6 hours prior to catheter removal in the 24 hour group in people with Urinary Retention, run by Cedars-Sinai Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Acute Urinary Retention (time frame: Postoperative day 1 or postpoperative 3 depending on group randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01923129, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2019.

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