Effect of Preoperative Single-dose Tamsulosin on Postoperative Urinary Retention After Mid-urethral Sling Placement: a Randomized, Double-blinded, Placebo-controlled Trial
Phase: PHASE3
Conditions: Postoperative Retention of Urine
Sponsor: Endeavor Health

Effect of preoperative single-dose tamsulosin on postoperative urinary retention after mid-urethral 
sling placement: a randomized, double-blinded, placebo-controlled trial 
  
Principal Investigator 
Angela Leffelman, MD 
 
Clinical Research Supervisor 
Ghazaleh Rostami, MD 
 
Sub-Investigator(s) 
Roger Goldberg, MD MPH 
Sonia Dutta, MD 
Adam Gafni-Kane, MD 
Ghazaleh Rostami, MD 
Joel Winer, MD MHS 
Henry Chill, MD 
  
Sponsor 
None 
  
Site of Investigation 
Northshore University Health System 
  
Date of Protocol:  04/08/2023 
NCT05753670 
 
Protocol Version:  2 
 
 

 
  
 
Purpose 
The purpose of this study is to evaluate whether a single dose of preoperative tamsulosin may improve 
postoperative urinary retention rates determined by postoperative retro-fill voiding trial compared with 
placebo. 
  
Background 
Postoperative urinary retention has been defined as the inability to void despite having fluid in the 
bladder during the postoperative period (3). Urinary retention after pelvic reconstructive surgery 
requiring indwelling catheter or self-catheterization usage occurs in approximately 30-60% of patients 
postoperatively (1,2,3).  
  
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 (4). 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 overdistention, 
pain and urinary tract infection (5). 
  
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 (1,6). 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 (8). 
  
Tamsulosin is an alpha-adrenergic receptor blocker which is thought to increase smooth muscle 
relaxation and improve urinary flow (9). 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 (9). Chapman, et al published a randomized control 
trial evaluating postoperative urinary retention after female pelvic reconstructive surgery (10). 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% (10). 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) (11). 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 (12-14). 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 (10-14). 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 (10,15). As the majority of female pelvic reconstructive 
surgeries performed by our department are same-day surgeries, with patients being discharged the day 

of surgery, we 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 (16). 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 (9). 
  
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 (9). No study to date has evaluated preoperative administration of single- dose tamsulosin for 
postoperative urinary retention in a randomized placebo-controlled trial. 
  
Hypothesis 
We hypothesize that providing preoperative tamsulosin will improve postoperative urinary retention 
rates determined by postoperative retro-fill voiding trial compared with placebo. 
  
Objectives 
The primary objective of this study is to evaluate whether preoperative administration of tamsulosin 
will decrease the rate of postoperative urinary retention after mid-urethral sling placement with or 
without concomitant prolapse surgery compared with placebo. The secondary objective of this study is 
to evaluate for any differences in hypotension, unplanned admission, postoperative UTI, or unplanned 
30-day healthcare encounters after preoperative tamsulosin compared to placebo. 
  
Specific Aims 
1.  
Compare the postoperative urinary retention rates after preoperative administration of 
tamsulosin compared with placebo.  
2.  
Compare differences in postoperative pain (postoperative nursing documentation 
performed in the recovery area based on a Likert scale of 0-10), hypotension (immediately 
postoperative) or postoperative UTI (UTI within 30 days of procedure) after preoperative 
administration of tamsulosin compared with placebo. 
3.  
Compare time to Foley catheter removal and voiding trial in the recovery area between 
the two study groups. 
4.  
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. 
5.  
Evaluate subjective measure of “feeling empty” after a void compared with PVR value. 
  
Outcome measures 
1.  
Primary outcome measure: 
a.           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. 
2.           Secondary outcome measures: 

a.           Determine differences in postoperative pain, hypotension, postoperative UTI after preoperative 
administration of tamsulosin compared with placebo. This data will be obtained by electronic data pull 
and chart review. 
b.           Determine time to Foley catheter removal and voiding trial in the recovery area between the 
two study groups which will be obtained by chart review of the documentation for Foley removal. 
c.           Determine the difference in unplanned admissions, office visits or Northshore encounters within 
30 days after surgery after preoperative administration of tamsulosin compared with placebo. This data 
will be collected via chart review. 
d.           Determine correlation between subjective measure of “feeling empty” and PVR. This will be 
documented in the electronic medical record by the postoperative nursing staff along with the PVR 
result obtained from ultrasound in the postoperative recovery area. 
  
Methods 
This is a prospective randomized, double-blinded, placebo- controlled trial of patients who are 
undergoing elective mid-urethral sling placement with or without concomitant prolapse surgery with 
the Center for Pelvic Health at the Northshore University Health System.  
  
Women presenting to our tertiary urogynecology clinic with stress urinary incontinence who decide to 
proceed with surgical treatment of stress urinary incontinence via a mid-urethral sling placement will be 
invited to participate in this study. This study will be discussed with the patient by their surgeon during 
their clinic initial screening visit or preoperative visit based on inclusion and exclusion criteria listed 
below. This study will involve no additional pre-operative tests or questionnaires, beyond our routine 
clinical pathway for women presenting with stress urinary incontinence. Written consent will be 
obtained.  
 
During the initial clinic visit, patients will be provided information on the research study by their care 
provider and given the opportunity to ask any questions. Patients will then be given a consent form to 
take home and review, discuss with others and consider participation. At the second clinic preoperative 
visit, patients will have another opportunity to discuss the study and ask any questions to their care 
provider. At that point, patients will be given the opportunity to sign the consent form if they would like 
to participate in the study. Participation is voluntary. For patients who will not have a second 
preoperative clinic visit prior to surgery, during the initial clinic visit, the care provider will discuss the 
research study, provide a consent form to the patient to review and ask for permission from the patient 
to be contacted by a study team member. If permission is granted, a study team member will contact 
the patient via telephone to discuss the study further and allow for the patient to consider participation 
in the study and ask any questions. If at that time the patient decides to participate in the study, written 
consent will be obtained the morning of surgery. All consent documentation and research participation 
will be documented in the patient’s chart. 
  
Patients who are undergoing a mid-urethral sling placement will be enrolled (after the previously 
described 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. 
  
Randomization will occur by simple randomization (1:1 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. 
  
After surgery, patients will then undergo a retro-fill voiding trial in the recovery area. The voiding trial 
will be performed as follows: using a Foley catheter placed in the OR, we will retro-fill the bladder with 
300mL of sterile normal saline (using the catheter that is already in place, a trained nurse will fill the 
bladder with sterile normal saline), the catheter will be removed and the patient will be asked to 
void.  The measured voided volume will be recorded and a bladder scan post-void residual (PVR) volume 
will be obtained. Patients will be asked if they “feel empty” as a subjective measure of voiding success. 
As described in prior studies, the patient will fail the voiding trial if voided volume is less than ⅓ total 
bladder volume and PVR is greater than or equal to 200mL. Upon failing the voiding trial, the patient will 
be discharged home with a Foley catheter with plan for outpatient follow up for catheter removal in 
clinic, consistent with our current protocol. According to our current protocol, patients discharged with 
a Foley catheter can either remove the catheter at home in 48-72 hours after surgery or call our office to 
have it removed at the next available appointment within 2-5 days postoperatively. 
  
We will then evaluate the rate of postoperative urinary retention after preoperative administration of 
tamsulosin compared with placebo. Any collected information will be de-identified. 
  
The current rate of postoperative urinary retention at our institution based on chart review is 25%. 
Published data discussed above have described a postoperative urinary retention rate decrease of 65-
88% (10-14). Based on a sample size calculation to achieve 80% power, to evaluate for a 65% decrease in 
our urinary retention rate (from 25% to approximately 8.8%) we will need to recruit 160 total subjects 
(80 per group). 
  
Inclusion criteria 
Mid-urethral sling placement (CPT 57228) 
  
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 
  
Variables 
MRN 
Age (at time of surgery) 
Gravity and para 
Race/ethnicity 
Smoking status  
Menopausal status  
BMI 

Comorbid conditions  
          
Diabetes 
          
Hypertension 
          
Other cardiovascular disease  
          
Respiratory disease 
          
Obstructive sleep apnea 
          
Chronic pain conditions 
Prior hysterectomy  
Prior abdominal surgery  
History of prior prolapse surgery 
Prolapse stage 
Location of surgery (Highland Park Hospital, Evanston) 
Type of anesthesia 
ASA grade 
Incontinence procedure 
Mid-urethral sling placement: CPT 57228 
Concomitant prolapse procedures 
Anterior colporrhaphy: CPT 57240 
Posterior colporrhaphy: CPT 57250 
Combined anterior and posterior colporrhaphy: CPT 57265 
Apical prolapse suspension 
 
 
Vaginal vault suspension 
 
 
Intraperitoneal: CPT 57283 
 
 
Extraperitoneal: CPT 57282 
 
 
Sacrocolpopexy: Minimally invasive (robotic-assisted and laparoscopic): CPT 57425 
Concomitant procedures 
 
Hysterectomy 
 
Rectopexy 
Intraoperative complications  
Additional procedures (lysis of adhesions) 
Intraoperative consultations 
Length of procedure 
Estimated blood loss 
Surgeon  
Surgeon experience (< 5 years, > 5 years) 
Total time in PACU 
Time of day in ASU 
Total time in ASU 
Immediate postoperative complications 
          
Uncontrolled nausea 
Uncontrolled pain  
Hypotension 
          
Incisional bleeding 
Postoperative pain scores upon admission to the ASU 
Postoperative pain scores at discharge 
Reason for postoperative admission (surgeon choice, comorbid conditions, nausea/vomiting, etc.) 
Time from voiding trial to void 
Subjective determination of “feeling empty” 

Postoperative urinary retention 
Postoperative urinary tract infection (UTI) 
Unanticipated healthcare encounters 
          
Urogynecology office visit (excluding voiding trial(s)) 
          
ED visit 
          
Readmission within 30 days of discharge 
          
Unplanned phone calls 
Complications 30 days after discharge 
          
Urinary tract infection 
          
Reoperation 
          
Venous thrombotic event   
  
Statistical Methodology 
A statistician from the NorthShore Research Institute will assist with statistical analysis. Data will be 
analyzed using SAS 9.4 (SAS Inc., Cary, NC). Demographic and clinical characteristics between groups will 
be compared using Student t-test (parametric) or Mann-Whitney U test (nonparametric) for continuous 
variables and Chi-squared test or Fisher exact test for categorical variables.  Multivariable logistic 
regression models will be constructed to examine the relationship of an outcome with demographic and 
clinical covariates. Statistical significance will be defined at p-value < 0.05. 
  
 
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