Effect of Preoperative Tamsulosin on Postoperative Urinary Retention

Sponsor

NorthShore University HealthSystem (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05753670

Collaborator

(none)

160

Enrollment

Location

Arms

Anticipated Duration (Months)

12.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Retention of Urine	Drug: Tamsulosin Drug: Placebo	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Randomization will occur by simple randomization with a computer-generated random number list. The patient will be randomized to one of the two groups (preoperative tamsulosin 0.4mg tablet versus placebo). This random number list will be sent directly from the statistician to the pharmacy. The clinician will place an order for the preoperative trial medication and the pharmacy will dispense either a single tablet of tamsulosin 0.4mg or placebo to the preoperative holding area according to the randomization list that the pharmacy has been provided by the statistician. The trial medication will be sent from the pharmacy to the preoperative area to be taken prior to surgery. The clinicians, preoperative and postoperative nursing staff, and the patients will be blinded to the trial group and medication.

Primary Purpose:

Prevention

Official Title:

Effect of Preoperative Single-dose Tamsulosin on Postoperative Urinary Retention After Mid-urethral Sling Placement: a Randomized, Double-blinded, Placebo-controlled Trial

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: 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.
Placebo Comparator: 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.	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.

Arm

Intervention/Treatment

Experimental: 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.

Drug: Tamsulosin

Placebo Comparator: 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.

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.

Outcome Measures

Primary Outcome Measures

Postoperative urinary retention [Immediate postoperative evaluation (1 day)]
Determine the postoperative urinary retention rates after preoperative administration of tamsulosin compared with placebo. This will be determined immediately postoperative in the postoperative recovery room based on whether patients pass or fail their voiding trial described above. The result will be documented in electronic medical records and obtained from chart review.

Secondary Outcome Measures

Postoperative pain [Immediate postoperative evaluation (1 day)]
Compare differences in postoperative pain (postoperative nursing documentation performed in the recovery area based on a Likert scale of 0-10 where 0 is no pain and 10 is extreme pain) after preoperative administration of tamsulosin compared with placebo.
Postoperative UTI [Chart review of 30 days postoperative after surgery]
Compare differences in the incidence of postoperative UTI (% of patients diagnosed with a UTI within 30 days of procedure) after preoperative administration of tamsulosin compared with placebo.
Unplanned admission or unplanned healthcare encounter [Chart review of 30 days postoperative after surgery]
Evaluate the difference in unplanned admission the day or surgery or unplanned admission within 30 days after surgery, unplanned office visits within 30 days after surgery or Northshore encounters within 30 days after surgery after preoperative administration tamsulosin compared with placebo. These medical encounters will include any need for additional medical treatment, phone calls, complications or patient concerns within 30 days postoperatively. This data will be collected via chart review.
Postoperative hypotension [Immediate postoperative evaluation (1 day)]
Compare the rates of hypotension (immediately postoperative) after preoperative administration of tamsulosin compared with placebo.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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
Concomitant prolapse surgery
Known contraindication to tamsulosin

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NorthShore University Health System	Evanston	Illinois	United States	60201

Sponsors and Collaborators

NorthShore University HealthSystem

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

NorthShore University HealthSystem

ClinicalTrials.gov Identifier:

NCT05753670

Other Study ID Numbers:

EH22-470

First Posted:

Mar 3, 2023

Last Update Posted:

Mar 8, 2023

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Urinary Retention

Tamsulosin

Study Results

No Results Posted as of Mar 8, 2023