Trial Outcomes & Findings for Effect of Preoperative Tamsulosin on Postoperative Urinary Retention (NCT NCT05753670)

Last Updated: 2025-10-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

179 participants

Primary outcome timeframe

Immediate postoperative evaluation (1 day)

Results posted on

2025-10-28

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	90	89
Overall Study COMPLETED	81	80
Overall Study NOT COMPLETED	9	9

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Withdrawal by Subject	6	8
Overall Study Protocol Violation	3	1

Baseline Characteristics

Effect of Preoperative Tamsulosin on Postoperative Urinary Retention

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tamsulosin n=80 Participants 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.	Placebo n=81 Participants 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.	Total n=161 Participants Total of all reporting groups
Age, Continuous	56.7 years STANDARD_DEVIATION 2 • n=5 Participants	56.4 years STANDARD_DEVIATION 2 • n=7 Participants	56.5 years STANDARD_DEVIATION 2 • n=5 Participants
Sex: Female, Male Female	80 Participants n=5 Participants	81 Participants n=7 Participants	161 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants n=5 Participants	11 Participants n=7 Participants	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	65 Participants n=5 Participants	70 Participants n=7 Participants	135 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	63 Participants n=5 Participants	56 Participants n=7 Participants	119 Participants n=5 Participants
Race (NIH/OMB) More than one race	12 Participants n=5 Participants	16 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Current smoker	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Postmenopausal	49 Participants n=5 Participants	45 Participants n=7 Participants	94 Participants n=5 Participants
Body Mass Index	28.88 kg/m^2 STANDARD_DEVIATION 5.97 • n=5 Participants	27.82 kg/m^2 STANDARD_DEVIATION 5.42 • n=7 Participants	28.35 kg/m^2 STANDARD_DEVIATION 5.71 • n=5 Participants

PRIMARY outcome

Timeframe: Immediate postoperative evaluation (1 day)

Outcome measures

Outcome measures
Measure	Tamsulosin n=80 Participants 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.	Placebo n=81 Participants 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.
Number of Participants With Postoperative Urinary Retention	14 Participants	16 Participants

SECONDARY outcome

Timeframe: Chart review of 30 days postoperative after surgery

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.

Outcome measures

Outcome measures
Measure	Tamsulosin n=80 Participants 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.	Placebo n=81 Participants 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.
Number of Participants With Postoperative Urinary Tract Infection (UTI)	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Tamsulosin n=80 Participants 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.	Placebo n=81 Participants 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.
Number of Participants With Unplanned Admission or Unplanned Healthcare Encounter	6 Participants	4 Participants

SECONDARY outcome

Timeframe: Immediate postoperative evaluation (1 day)

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

Outcome measures

Outcome measures
Measure	Tamsulosin n=80 Participants 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.	Placebo n=81 Participants 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.
Number of Participants With Postoperative Hypotension or Syncope	2 Participants	0 Participants

Adverse Events

Tamsulosin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ghazaleh Rostami Nia

Endeavor Health

Phone: 847-570-4729

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place