Urinary Retention Postoperative
Conditions
Brief summary
The aim of this study is to determine if a one time dose of tamsulosin given pre-operatively decreases the time to void and the time to discharge after minimally invasive hysterectomy.
Interventions
DRUGTamsulosin
Participants will be given Tamsulosin or placebo in the pre-op bay prior to surgery. Post-operatively, time to void and time to discharge from the post-anesthesia care unit will be recorded.
DRUGPlacebo
Participants will be given Tamsulosin or placebo in the pre-op bay prior to surgery. Post-operatively, time to void and time to discharge from the post-anesthesia care unit will be recorded.
Sponsors
University of Arizona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Women 18-80 undergoing outpatient minimally invasive hysterectomy
Exclusion criteria
* Inability to provide informed consent * Bladder malignancy * Intra-operative bladder or ureteral injury; anticipated prolonged bladder catheterization * Plan for sling or anterior repair
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Spontaneous Void | 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Discharge From the Post-anesthesia Care Unit | 8 weeks | The 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tamsulosin- Intervention Group Tamsulosin arm: Participants will be given Tamsulosin in the pre-op bay | 77 |
| Placebo Group Placebo arm: Participants will be given Placebo the pre-op bay. | 73 |
| Total | 150 |
Baseline characteristics
| Characteristic | Total | Tamsulosin- Intervention Group | Placebo Group |
|---|---|---|---|
| Age, Continuous | 41 years | 41 years | 42 years |
| Body mass index | 30 kg/m^2 | 30 kg/m^2 | 31 kg/m^2 |
| Charston Comorbidity index Score 0 (no health conditions) | 120 Participants | 62 Participants | 58 Participants |
| Charston Comorbidity index Score 1 | 22 Participants | 11 Participants | 11 Participants |
| Charston Comorbidity index Score 2 | 7 Participants | 3 Participants | 4 Participants |
| Charston Comorbidity index Score 3 | 0 Participants | 0 Participants | 0 Participants |
| Charston Comorbidity index Score 4 (several health conditions) | 1 Participants | 1 Participants | 0 Participants |
| Current smoker | 20 Participants | 12 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 34 Participants | 19 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 93 Participants | 46 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 23 Participants | 12 Participants | 11 Participants |
| Parity | 2 Living births | 2 Living births | 2 Living births |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 10 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 18 Participants | 8 Participants | 10 Participants |
| Race (NIH/OMB) White | 116 Participants | 62 Participants | 54 Participants |
| Region of Enrollment United States | 150 participants | 77 participants | 73 participants |
| Sex: Female, Male Female | 150 Participants | 77 Participants | 73 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 81 | 0 / 80 |
| other Total, other adverse events | 4 / 81 | 3 / 80 |
| serious Total, serious adverse events | 2 / 81 | 1 / 80 |
Outcome results
Primary
Time to Spontaneous Void
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tamsulosin- Intervention Group | Time to Spontaneous Void | 1.63 hours |
| Placebo Group | Time to Spontaneous Void | 1.42 hours |
Secondary
Time to Discharge From the Post-anesthesia Care Unit
The 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.
Time frame: 8 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tamsulosin- Intervention Group | Time to Discharge From the Post-anesthesia Care Unit | 2.4 hours |
| Placebo Group | Time to Discharge From the Post-anesthesia Care Unit | 2.6 hours |