Trial Outcomes & Findings for Use of Tamsulosin to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery (NCT NCT01568918)

Last Updated: 2024-05-30

Results Overview

Post operative urinary retention (POUR) will be defined as any of the following: 1\) Estimated post-void residual (PVR) volume of urine greater than or equal to 300 mL; 2) Estimated retention urine volume of greater than or equal to 500 mL in patients unable to void; 3) Patients experiencing discomfort or distension and unable to void with lesser residual urine volume than 500 ml.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

90 participants

Primary outcome timeframe

participants will be followed for the duration of the hospital stay, an expected average of 5 days

Results posted on

2024-05-30

Participant Flow

Participant milestones

Participant milestones
Measure	Tamsulosin Participants randomized to this arm will receive 0.4 mg/day tamsulosin hydrochloride from 5 days prior to the operation until hospital discharge. Tamsulosin hydrochloride: Participants will receive 0.4 mg/day tamsulosin hydrochloride from 5 days prior to the operation until hospital discharge.	Placebo Participants randomized to this arm will receive a daily placebo capsule matching the active study drug from 5 days prior to the operation until hospital discharge. Placebo: The placebo capsule matching the active study drug will be given daily from 5 days prior to the operation until hospital discharge.
Overall Study STARTED	39	51
Overall Study COMPLETED	39	51
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Use of Tamsulosin to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tamsulosin n=39 Participants Participants randomized to this arm will receive 0.4 mg/day tamsulosin hydrochloride from 5 days prior to the operation until hospital discharge. Tamsulosin hydrochloride: Participants will receive 0.4 mg/day tamsulosin hydrochloride from 5 days prior to the operation until hospital discharge.	Placebo n=51 Participants Participants randomized to this arm will receive a daily placebo capsule matching the active study drug from 5 days prior to the operation until hospital discharge. Placebo: The placebo capsule matching the active study drug will be given daily from 5 days prior to the operation until hospital discharge.	Total n=90 Participants Total of all reporting groups
Age, Continuous	61.04 years STANDARD_DEVIATION 10.36 • n=5 Participants	63.59 years STANDARD_DEVIATION 9.91 • n=7 Participants	62.47 years STANDARD_DEVIATION 10.12 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	20 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	31 Participants n=7 Participants	55 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants n=5 Participants	51 Participants n=7 Participants	90 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	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	39 Participants n=5 Participants	51 Participants n=7 Participants	90 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	39 participants n=5 Participants	51 participants n=7 Participants	90 participants n=5 Participants

PRIMARY outcome

Timeframe: participants will be followed for the duration of the hospital stay, an expected average of 5 days

Outcome measures

Outcome measures
Measure	Tamsulosin n=39 Participants Participants randomized to this arm will receive 0.4 mg/day tamsulosin hydrochloride from 5 days prior to the operation until hospital discharge. Tamsulosin hydrochloride: Participants will receive 0.4 mg/day tamsulosin hydrochloride from 5 days prior to the operation until hospital discharge.	Placebo n=51 Participants Participants randomized to this arm will receive a daily placebo capsule matching the active study drug from 5 days prior to the operation until hospital discharge. Placebo: The placebo capsule matching the active study drug will be given daily from 5 days prior to the operation until hospital discharge.
Incidence of Postoperative Urinary Retention	11 Participants	20 Participants

SECONDARY outcome

Timeframe: participants will be followed for the duration of the hospital stay, an expected average of 5 days

The neurosurgical team will decide if an indwelling urinary catheter will be used. Time of indwelling catheter removal after surgery will serve as time zero for beginning calculation of postoperative urinary retention duration if the patient later requires in and out straight catheterization. For patients without an indwelling catheter, the time patients leave the operating room will serve as time zero. Urinary retention will be considered resolved after two consecutive post-void residual urine scans have demonstrated less than 300 ml residual urine volume in a patient spontaneously voiding.

Outcome measures

Outcome measures
Measure	Tamsulosin n=39 Participants Participants randomized to this arm will receive 0.4 mg/day tamsulosin hydrochloride from 5 days prior to the operation until hospital discharge. Tamsulosin hydrochloride: Participants will receive 0.4 mg/day tamsulosin hydrochloride from 5 days prior to the operation until hospital discharge.	Placebo n=51 Participants Participants randomized to this arm will receive a daily placebo capsule matching the active study drug from 5 days prior to the operation until hospital discharge. Placebo: The placebo capsule matching the active study drug will be given daily from 5 days prior to the operation until hospital discharge.
Duration of Postoperative Urinary Retention	3.42 days Standard Deviation 0.932	3.52 days Standard Deviation 1.210

Adverse Events

Tamsulosin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Tamsulosin n=39 participants at risk Participants randomized to this arm will receive 0.4 mg/day tamsulosin hydrochloride from 5 days prior to the operation until hospital discharge. Tamsulosin hydrochloride: Participants will receive 0.4 mg/day tamsulosin hydrochloride from 5 days prior to the operation until hospital discharge.	Placebo n=51 participants at risk Participants randomized to this arm will receive a daily placebo capsule matching the active study drug from 5 days prior to the operation until hospital discharge. Placebo: The placebo capsule matching the active study drug will be given daily from 5 days prior to the operation until hospital discharge.
General disorders Lower Extremity Edema	0.00% 0/39 • Adverse events were collected from baseline to first follow-up postop (approximately 3 months) on all participants.	2.0% 1/51 • Number of events 1 • Adverse events were collected from baseline to first follow-up postop (approximately 3 months) on all participants.

Additional Information

Michelle Clarke, M.D.

Mayo Clinic

Phone: (507) 284-5317

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place