Trial Outcomes & Findings for Pre-operative Tamsulosin and Time to Spontaneous Void After Hysterectomy (NCT NCT04859660)
NCT ID: NCT04859660
Last Updated: 2024-02-29
Results Overview
Each participant underwent a void trial post-operatively by backfilling their bladder with 200cc normal saline at the conclusion of the case and removing the foley. Patients needed to void at least 100cc to be considered to have "passed" their void trial.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
161 participants
Primary outcome timeframe
8 weeks
Results posted on
2024-02-29
Participant Flow
Participant milestones
| Measure |
Tamsulosin- Intervention Group
Tamsulosin arm: Participants will receive a single dose of 0.4mg oral Tamsulosin capsule in the pre-op bay 1-2 hours before surgery.
|
Placebo Group
Placebo arm: Participants will receive a single dose of oral placebo capsule in the pre-op bay 1-2 hours before surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
81
|
80
|
|
Overall Study
COMPLETED
|
77
|
73
|
|
Overall Study
NOT COMPLETED
|
4
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pre-operative Tamsulosin and Time to Spontaneous Void After Hysterectomy
Baseline characteristics by cohort
| Measure |
Tamsulosin- Intervention Group
n=77 Participants
Tamsulosin arm: Participants will be given Tamsulosin in the pre-op bay
|
Placebo Group
n=73 Participants
Placebo arm: Participants will be given Placebo the pre-op bay.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41 years
n=99 Participants
|
42 years
n=107 Participants
|
41 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=99 Participants
|
73 Participants
n=107 Participants
|
150 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
93 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
62 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
116 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
77 participants
n=99 Participants
|
73 participants
n=107 Participants
|
150 participants
n=206 Participants
|
|
Body mass index
|
30 kg/m^2
n=99 Participants
|
31 kg/m^2
n=107 Participants
|
30 kg/m^2
n=206 Participants
|
|
Current smoker
|
12 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Parity
|
2 Living births
n=99 Participants
|
2 Living births
n=107 Participants
|
2 Living births
n=206 Participants
|
|
Charston Comorbidity index
Score 0 (no health conditions)
|
62 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
120 Participants
n=206 Participants
|
|
Charston Comorbidity index
Score 1
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Charston Comorbidity index
Score 2
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Charston Comorbidity index
Score 3
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Charston Comorbidity index
Score 4 (several health conditions)
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 8 weeksEach participant underwent a void trial post-operatively by backfilling their bladder with 200cc normal saline at the conclusion of the case and removing the foley. Patients needed to void at least 100cc to be considered to have "passed" their void trial.
Outcome measures
| Measure |
Tamsulosin- Intervention Group
n=77 Participants
Tamsulosin arm: Participants will be given Tamsulosin in the pre-op bay
|
Placebo Group
n=73 Participants
Placebo arm: Participants will be given Placebo the pre-op bay.
|
|---|---|---|
|
Time to Spontaneous Void
|
1.63 hours
Interval 0.94 to 2.44
|
1.42 hours
Interval 0.84 to 2.33
|
SECONDARY outcome
Timeframe: 8 weeksThe time from the patient leaving the OR to the time they were discharged home from the Post-anesthesia care unit was recorded to determine the Time to discharge.
Outcome measures
| Measure |
Tamsulosin- Intervention Group
n=77 Participants
Tamsulosin arm: Participants will be given Tamsulosin in the pre-op bay
|
Placebo Group
n=73 Participants
Placebo arm: Participants will be given Placebo the pre-op bay.
|
|---|---|---|
|
Time to Discharge From the Post-anesthesia Care Unit
|
2.4 hours
Interval 1.7 to 3.5
|
2.6 hours
Interval 1.9 to 3.5
|
Adverse Events
Tamsulosin- Intervention Group
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo Group
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tamsulosin- Intervention Group
n=81 participants at risk
Tamsulosin arm: Participants will be given Tamsulosin in the pre-op bay
|
Placebo Group
n=80 participants at risk
Placebo arm: Participants will be given Placebo the pre-op bay.
|
|---|---|---|
|
Cardiac disorders
Hospital admission
|
0.00%
0/81 • 8 weeks
Participation in this study involves minimal risk
|
1.2%
1/80 • Number of events 1 • 8 weeks
Participation in this study involves minimal risk
|
|
Reproductive system and breast disorders
Vaginal cuff dehiscence
|
2.5%
2/81 • Number of events 2 • 8 weeks
Participation in this study involves minimal risk
|
0.00%
0/80 • 8 weeks
Participation in this study involves minimal risk
|
Other adverse events
| Measure |
Tamsulosin- Intervention Group
n=81 participants at risk
Tamsulosin arm: Participants will be given Tamsulosin in the pre-op bay
|
Placebo Group
n=80 participants at risk
Placebo arm: Participants will be given Placebo the pre-op bay.
|
|---|---|---|
|
Renal and urinary disorders
Urinary tract infection
|
1.2%
1/81 • Number of events 1 • 8 weeks
Participation in this study involves minimal risk
|
1.2%
1/80 • Number of events 1 • 8 weeks
Participation in this study involves minimal risk
|
|
Reproductive system and breast disorders
Pelvic abscess
|
2.5%
2/81 • Number of events 2 • 8 weeks
Participation in this study involves minimal risk
|
0.00%
0/80 • 8 weeks
Participation in this study involves minimal risk
|
|
Gastrointestinal disorders
Gastritis
|
1.2%
1/81 • Number of events 1 • 8 weeks
Participation in this study involves minimal risk
|
0.00%
0/80 • 8 weeks
Participation in this study involves minimal risk
|
|
Renal and urinary disorders
Kidney stone
|
0.00%
0/81 • 8 weeks
Participation in this study involves minimal risk
|
1.2%
1/80 • Number of events 1 • 8 weeks
Participation in this study involves minimal risk
|
|
Reproductive system and breast disorders
vaginal bleeding
|
0.00%
0/81 • 8 weeks
Participation in this study involves minimal risk
|
1.2%
1/80 • Number of events 1 • 8 weeks
Participation in this study involves minimal risk
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place