N/A
N=142
Optimal Duration of Indwelling Urinary Catheter Following Pelvic Surgery
Urinary Retention
Bottom Line
View on ClinicalTrials.gov: NCT01923129 ↗Enrolled (actual)
142
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Number of Participants With Acute Urinary Retention — 6; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Prazosin given 6 hours prior to catheter removal in the 24 hour group (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cedars-Sinai Medical Center
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Acute Urinary Retention |
6; 7 | — |
| SECONDARY Number of Participants With a Symptomatic Urinary Tract Infection |
0; 8 | <0.05 sig |
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).
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures;
- Children 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:
- Catheter pulled out inadvertently;
- Postoperative complications requiring prolonged monitoring of urine output
- Postoperative complications requiring early reoperation
Data sourced from ClinicalTrials.gov (NCT01923129). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.