Clinical trial NCT05753670: Effect of Preoperative Tamsulosin on Postoperative Urinary Retention
Official title: Effect of Preoperative Single-dose Tamsulosin on Postoperative Urinary Retention After Mid-urethral Sling Placement: a Randomized, Double-blinded, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Retention of Urine
Lead sponsor: Endeavor Health
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 183
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective randomized, double-blinded, placebo- controlled trial of patients who are undergoing elective mid-urethral sling placement with the Center for Pelvic Health at the Northshore University Health System. Written consent will be obtained.

Patients who are undergoing a mid-urethral sling placement will be enrolled (after an informed consent discussion) to receive either a single tablet of tamsulosin 0.4mg or a placebo in the preoperative holding area on the day of their scheduled surgery.
Primary purpose: PREVENTION

Brief summary: Approximately 25-30% of patients experience postoperative urinary retention after female pelvic surgery with mid-urethral sling placement. These patients are discharged home with a foley catheter for a few days. Despite being common, many patients consider being discharged home with a foley catheter as a complication of surgery and as the worst part of their experience. Previous studies have demonstrated that 3-5 days of preoperative tamsulosin (a safe and low-cost medication) have been shown to improve postoperative urinary retention rates. Although it takes tamsulosin 5 days to reach a steady-state in a patient, it reaches peak blood volume in 4-5 hours in a fasting patient. The effect of a single dose of preoperative tamsulosin on postoperative urinary retention has not been studied, however would be substantially easier for patients than multiple days of preoperative doses. In this study, the investigators would like to give patients preoperative tamsulosin versus placebo. The investigators would then evaluate for postoperative urinary retention. Previous studies have demonstrated a postoperative urinary retention rate decrease of 65-88% after various tamsulosin protocols. However, the effect of single preoperative dose of tamusloin on postoperative urinary retention has yet to be studied in female pelvic surgery. The investigators hypothesize that a single preoperative dose of tamsulosin will decrease the number of patients with postoperative urinary retention and therefore discharged with a foley catheter. Our goal is to improve patient outcomes and satisfaction postoperatively.

Detailed description: Postoperative urinary retention has been defined as the inability to void despite having fluid in the bladder during the postoperative period. Urinary retention after pelvic reconstructive surgery requiring indwelling catheter or self-catheterization usage occurs in approximately 30-60% of patients postoperatively.

During a retro-fill voiding trial, the bladder is back-filled with a set amount of sterile water (often 300mL), the catheter is removed, the patient is permitted to void and the voided volume is compared with a bladder scan post void residual volume. "Passing" a voiding trial has previously been defined as voiding equal or greater than ⅔ the residual volume, whereas others characterize "passing" as voiding at least 200mL and voiding a greater volume than the post-void residual volume. If the patient does not "pass" the voiding trial, the patient is characterized as having postoperative urinary retention and is discharged home with an indwelling catheter to prevent detrusor injury from bladder over-distention, pain and urinary tract infection.

Many women consider being discharged home with a foley catheter to be a surgical complication and describe catheter use as the worst aspect of their surgery. Indwelling catheters are the leading cause of hospital-acquired urinary tract infections (UTIs), are often a source of embarrassment and inconvenience for patients, and often require additional office visits and healthcare utilization.

Tamsulosin is an alpha-adrenergic receptor blocker which is thought to increase smooth muscle relaxation and improve urinary flow. Current literature has been primarily focused on the effect of tamsulosin in men with benign prostatic hyperplasia, however may be beneficial in women as well with limited studies for postoperative urinary retention. Chapman, et al published a randomized control trial evaluating postoperative urinary retention after female pelvic reconstructive surgery. These patients underwent 10 days of tamsulosin (3 days preoperative and 7 days postoperative) and were found to have a 65% decrease in the urinary retention rate from 25.8% to 8.8%. Livne, et al published a study evaluating postoperative urinary retention decrease of 79.2% after postoperative administration of dibenzyline (an alpha-adrenergic receptor blocker) in women undergoing hysterectomy (post-operative urinary retention rate of 18.75% in controls and 3.9% in the treatment group). Additional studies have also been published evaluating postoperative urinary retention in men and women undergoing various surgeries and have demonstrated a decrease in postoperative urinary retention after tamsulosin administration from 72-88% compared with controls. These studies vary in tamsulosin administration from multiple days preoperative and postoperative to multiple doses preoperative and postoperative to a single postoperative dose, however no studies have been published in evaluating a single preoperative dose of tamsulosin and the effect on postoperative urinary retention. This has previously been studied as tamsulosin reaches a steady state in approximately 5 days, however when tamsulosin is given in a fasting patient, it can reach the maximum blood concentration in approximately 4-5 hours. As the majority of female pelvic reconstructive surgeries performed by our department are same-day surgeries, with patients being discharged the day of surgery, the investigators would like to investigate the effect of a single preoperative dose of tamsulosin on postoperative urinary retention and, by effect, home catheter usage after surgery. Tamsulosin is cost-effective at approximately $2 per tablet. Despite primarily being prescribed for benign prostatic hyperplasia, tamsulosin has been found to be a safe and well-tolerated treatment for voiding dysfunction in women.

Postoperative urinary retention is common after pelvic reconstructive surgery with mid-urethral sling placement and is extremely bothersome to patients. Tamsulosin is a low-risk, well tolerated, cost-effective medication that studies have suggested may decrease the rate of postoperative urinary retention. No study to date has evaluated preoperative administration of single- dose tamsulosin for postoperative urinary retention in a randomized placebo-controlled trial.

Eligibility criteria: Inclusion Criteria:

* Mid-urethral sling placement

Exclusion Criteria:

* Age \<18
* Planned combined cases with colorectal surgery, general surgery, or gynecology-oncology
* Planned sling revision or history of prior sling placement
* Known history of urinary retention
* Concomitant intravesical botulinum injections
* Known contraindication to tamsulosin

Primary outcomes:
measure: Postoperative urinary retention
timeFrame: Immediate postoperative evaluation (1 day)
Secondary outcomes:
measure: Postoperative pain
timeFrame: Immediate postoperative evaluation (1 day)
measure: Postoperative UTI
timeFrame: Chart review of 30 days postoperative after surgery
measure: Unplanned admission or unplanned healthcare encounter
timeFrame: Chart review of 30 days postoperative after surgery
measure: Postoperative hypotension
timeFrame: Immediate postoperative evaluation (1 day)
Other outcomes:
Locations:
city: Evanston
country: United States
facility: NorthShore University Health System
state: Illinois
Study officials:
References:
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