Effect of Preoperative Tamsulosin on Postoperative Urinary Retention

NCT ID: NCT05753670

Last Updated: 2025-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 179 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2024-06-02

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.

Conditions

Postoperative Retention of Urine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Tamsulosin

Subjects randomized to the experimental arm will receive a single dose of 0.4mg Tamsulosin tablet in the preoperative holding area prior to their scheduled mid-urethral sling placement in the operating room.

Group Type: EXPERIMENTAL

Tamsulosin

Intervention Type: DRUG

Subjects randomized to the experimental arm will receive a single dose of 0.4mg Tamsulosin tablet in the preoperative holding area prior to their scheduled mid-urethral sling placement in the operating room.

Placebo

Subjects randomized to the control arm will receive a single dose of a placebo tablet in the preoperative holding area prior to their scheduled mid-urethral sling placement in the operating room.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Subjects randomized to the control arm will receive a single dose of a placebo tablet in the preoperative holding area prior to their scheduled mid-urethral sling placement in the operating room.

Interventions

Tamsulosin

Subjects randomized to the experimental arm will receive a single dose of 0.4mg Tamsulosin tablet in the preoperative holding area prior to their scheduled mid-urethral sling placement in the operating room.

Intervention Type: DRUG

Placebo

Subjects randomized to the control arm will receive a single dose of a placebo tablet in the preoperative holding area prior to their scheduled mid-urethral sling placement in the operating room.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Endeavor Health

OTHER

Sponsor Role: lead

Responsible Party

Ghazaleh Rostami Nia

Director of Research Division of Urogynecology, NorthShore University HealthSystem

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

NorthShore University Health System

Evanston, Illinois, United States

Countries

United States

References

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EH22-470

Identifier Type: -

Identifier Source: org_study_id