Skip to content

Effect of Preoperative Tamsulosin on Postoperative Urinary Retention

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05753670
Enrollment
179
Registered
2023-03-03
Start date
2023-07-01
Completion date
2024-06-02
Last updated
2025-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Retention of Urine

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.

Interventions

DRUGTamsulosin

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.

DRUGPlacebo

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.

Sponsors

Endeavor Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, 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.

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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 99 Years
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 * Known contraindication to tamsulosin

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Postoperative Urinary RetentionImmediate 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

MeasureTime frameDescription
Number of Participants With Postoperative Urinary Tract Infection (UTI)Chart review of 30 days postoperative after surgeryCompare differences in the incidence of postoperative UTI (number of participants diagnosed with a UTI within 30 days of procedure) after preoperative administration of tamsulosin compared with placebo.
Number of Participants With Unplanned Admission or Unplanned Healthcare EncounterChart review of 30 days postoperative after surgeryEvaluate 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.
Number of Participants With Postoperative Hypotension or SyncopeImmediate postoperative evaluation (1 day)Compare the number of participants with hypotension or syncope (immediately postoperative) after preoperative administration of tamsulosin compared with placebo.

Countries

United States

Participant flow

Participants by arm

ArmCount
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. 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.
80
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. 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.
81
Total161

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyProtocol Violation31
Overall StudyWithdrawal by Subject68

Baseline characteristics

CharacteristicTamsulosinPlaceboTotal
Age, Continuous56.7 years
STANDARD_DEVIATION 2
56.4 years
STANDARD_DEVIATION 2
56.5 years
STANDARD_DEVIATION 2
Body Mass Index28.88 kg/m^2
STANDARD_DEVIATION 5.97
27.82 kg/m^2
STANDARD_DEVIATION 5.42
28.35 kg/m^2
STANDARD_DEVIATION 5.71
Current smoker3 Participants6 Participants9 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
15 Participants11 Participants26 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
65 Participants70 Participants135 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Postmenopausal49 Participants45 Participants94 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Asian
4 Participants4 Participants8 Participants
Race (NIH/OMB)
Black or African American
1 Participants2 Participants3 Participants
Race (NIH/OMB)
More than one race
12 Participants16 Participants28 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants2 Participants2 Participants
Race (NIH/OMB)
White
63 Participants56 Participants119 Participants
Sex: Female, Male
Female
80 Participants81 Participants161 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 800 / 81
other
Total, other adverse events
0 / 800 / 81
serious
Total, serious adverse events
0 / 800 / 81

Outcome results

Primary

Number of Participants With Postoperative Urinary Retention

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.

Time frame: Immediate postoperative evaluation (1 day)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
TamsulosinNumber of Participants With Postoperative Urinary Retention14 Participants
PlaceboNumber of Participants With Postoperative Urinary Retention16 Participants
Secondary

Number of Participants With Postoperative Hypotension or Syncope

Compare the number of participants with hypotension or syncope (immediately postoperative) after preoperative administration of tamsulosin compared with placebo.

Time frame: Immediate postoperative evaluation (1 day)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
TamsulosinNumber of Participants With Postoperative Hypotension or Syncope2 Participants
PlaceboNumber of Participants With Postoperative Hypotension or Syncope0 Participants
Secondary

Number of Participants With Postoperative Urinary Tract Infection (UTI)

Compare differences in the incidence of postoperative UTI (number of participants diagnosed with a UTI within 30 days of procedure) after preoperative administration of tamsulosin compared with placebo.

Time frame: Chart review of 30 days postoperative after surgery

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
TamsulosinNumber of Participants With Postoperative Urinary Tract Infection (UTI)1 Participants
PlaceboNumber of Participants With Postoperative Urinary Tract Infection (UTI)1 Participants
Secondary

Number of Participants With Unplanned Admission or Unplanned Healthcare Encounter

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.

Time frame: Chart review of 30 days postoperative after surgery

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
TamsulosinNumber of Participants With Unplanned Admission or Unplanned Healthcare Encounter6 Participants
PlaceboNumber of Participants With Unplanned Admission or Unplanned Healthcare Encounter4 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026