Trial Outcomes & Findings for Trial of Prophylactic Tamsulosin for Postoperative Urinary Retention in Primary Total Hip and Knee Arthroplasty Patients (NCT NCT02518971)
NCT ID: NCT02518971
Last Updated: 2019-04-12
Results Overview
Patients who have not developed POUR will have two consecutive, spontaneous urine voids with residual volume of less than 200 mL, as determined by bladder scan or straight catheterization. Patients who do not successfully have the two spontaneous urine voids of less than 200 mL will be considered as having developed POUR. The incidence of POUR will be compared statistically between those taking and not taking tamsulosin at the time of surgery.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
176 participants
Primary outcome timeframe
Postop day 1
Results posted on
2019-04-12
Participant Flow
176 subjects were enrolled in the study. 174 were randomized to either the active tamsulosin group or placebo group and 2 subjects were withdrawn prior to randomization. 43 additional patients were withdrawn after randomization.
Participant milestones
| Measure |
Tamsulosin
0.4 mg daily for five days pre-op through post-op day one (seven total)
Tamsulosin: 0.4 mg daily
|
Placebo
One capsule daily for five days pre-op through post-op day one (seven total)
Placebo: one capsule daily
|
|---|---|---|
|
Overall Study
STARTED
|
87
|
87
|
|
Overall Study
COMPLETED
|
64
|
67
|
|
Overall Study
NOT COMPLETED
|
23
|
20
|
Reasons for withdrawal
| Measure |
Tamsulosin
0.4 mg daily for five days pre-op through post-op day one (seven total)
Tamsulosin: 0.4 mg daily
|
Placebo
One capsule daily for five days pre-op through post-op day one (seven total)
Placebo: one capsule daily
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Physician Decision
|
6
|
6
|
|
Overall Study
Protocol Violation
|
6
|
4
|
|
Overall Study
Withdrawal by Subject
|
4
|
5
|
|
Overall Study
Side effects
|
1
|
0
|
|
Overall Study
medication lost in mail
|
0
|
1
|
|
Overall Study
eligibility criteria no longer met
|
6
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Tamsulosin
n=64 Participants
0.4 mg daily for five days pre-op through post-op day one (seven total)
Tamsulosin: 0.4 mg daily
|
Placebo
n=67 Participants
One capsule daily for five days pre-op through post-op day one (seven total)
Placebo: one capsule daily
|
Total
n=131 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.55 years
STANDARD_DEVIATION 10.4 • n=64 Participants
|
61.37 years
STANDARD_DEVIATION 9.6 • n=67 Participants
|
60.98 years
STANDARD_DEVIATION 9.96 • n=131 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=64 Participants
|
0 Participants
n=67 Participants
|
0 Participants
n=131 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=64 Participants
|
67 Participants
n=67 Participants
|
131 Participants
n=131 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Postop day 1Patients who have not developed POUR will have two consecutive, spontaneous urine voids with residual volume of less than 200 mL, as determined by bladder scan or straight catheterization. Patients who do not successfully have the two spontaneous urine voids of less than 200 mL will be considered as having developed POUR. The incidence of POUR will be compared statistically between those taking and not taking tamsulosin at the time of surgery.
Outcome measures
| Measure |
Tamsulosin
n=64 Participants
0.4 mg daily for five days pre-op through post-op day one (seven total)
Tamsulosin: 0.4 mg daily
|
Placebo
n=67 Participants
One capsule daily for five days pre-op through post-op day one (seven total)
Placebo: one capsule daily
|
|---|---|---|
|
Number of Patients to Develop Postoperative Urinary Retention (POUR)
|
18 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 1-4 days postoperativeLength of hospital stay will be recorded in days and compared statistically between the two groups .
Outcome measures
| Measure |
Tamsulosin
n=64 Participants
0.4 mg daily for five days pre-op through post-op day one (seven total)
Tamsulosin: 0.4 mg daily
|
Placebo
n=67 Participants
One capsule daily for five days pre-op through post-op day one (seven total)
Placebo: one capsule daily
|
|---|---|---|
|
Length of Hospital Stay
|
1.125 days
Standard Deviation 0.42
|
1.209 days
Standard Deviation 0.64
|
SECONDARY outcome
Timeframe: 1-4 days postoperativeDischarge to a skilled nursing facility will be recorded (yes/no) and compared statistically between the two groups.
Outcome measures
| Measure |
Tamsulosin
n=64 Participants
0.4 mg daily for five days pre-op through post-op day one (seven total)
Tamsulosin: 0.4 mg daily
|
Placebo
n=67 Participants
One capsule daily for five days pre-op through post-op day one (seven total)
Placebo: one capsule daily
|
|---|---|---|
|
Incidence of Discharge to a Skilled Nursing Facility
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to two weeks postoperativeSurgical site infection will be recorded (yes/no) and compared statistically between the two groups.
Outcome measures
| Measure |
Tamsulosin
n=64 Participants
0.4 mg daily for five days pre-op through post-op day one (seven total)
Tamsulosin: 0.4 mg daily
|
Placebo
n=64 Participants
One capsule daily for five days pre-op through post-op day one (seven total)
Placebo: one capsule daily
|
|---|---|---|
|
Incidence of Surgical Site Infection
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Postoperative day 1 to day of discharge (1-4 days on average)The dosages of postoperative pain medications will be compared statistically between the two groups.
Outcome measures
| Measure |
Tamsulosin
n=64 Participants
0.4 mg daily for five days pre-op through post-op day one (seven total)
Tamsulosin: 0.4 mg daily
|
Placebo
n=67 Participants
One capsule daily for five days pre-op through post-op day one (seven total)
Placebo: one capsule daily
|
|---|---|---|
|
Acute Postoperative Pain Medication Dosages
|
44.85 morphine equivalent doses
Standard Deviation 47.18
|
36 morphine equivalent doses
Standard Deviation 31.56
|
SECONDARY outcome
Timeframe: Up to 31 days postoperativePostoperative complications will be recorded and the incidence will be compared statistically between the two groups.
Outcome measures
| Measure |
Tamsulosin
n=64 Participants
0.4 mg daily for five days pre-op through post-op day one (seven total)
Tamsulosin: 0.4 mg daily
|
Placebo
n=67 Participants
One capsule daily for five days pre-op through post-op day one (seven total)
Placebo: one capsule daily
|
|---|---|---|
|
Incidence of Postoperative Complications
|
2 Participants
|
2 Participants
|
Adverse Events
Tamsulosin
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Not Randomized
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tamsulosin
n=64 participants at risk
0.4 mg daily for five days pre-op through post-op day one (seven total)
Tamsulosin: 0.4 mg daily
|
Placebo
n=67 participants at risk
One capsule daily for five days pre-op through post-op day one (seven total)
Placebo: one capsule daily
|
Not Randomized
n=2 participants at risk
Participants were withdrawn from study before randomization
|
|---|---|---|---|
|
Eye disorders
Floppy Iris Syndrome
|
3.1%
2/64 • Number of events 2 • 31 days post-operatively
|
0.00%
0/67 • 31 days post-operatively
|
0.00%
0/2 • 31 days post-operatively
|
Other adverse events
| Measure |
Tamsulosin
n=64 participants at risk
0.4 mg daily for five days pre-op through post-op day one (seven total)
Tamsulosin: 0.4 mg daily
|
Placebo
n=67 participants at risk
One capsule daily for five days pre-op through post-op day one (seven total)
Placebo: one capsule daily
|
Not Randomized
n=2 participants at risk
Participants were withdrawn from study before randomization
|
|---|---|---|---|
|
Cardiac disorders
hypotension
|
0.00%
0/64 • 31 days post-operatively
|
3.0%
2/67 • Number of events 2 • 31 days post-operatively
|
0.00%
0/2 • 31 days post-operatively
|
|
General disorders
Dizziness
|
1.6%
1/64 • Number of events 1 • 31 days post-operatively
|
3.0%
2/67 • Number of events 2 • 31 days post-operatively
|
0.00%
0/2 • 31 days post-operatively
|
|
General disorders
Syncope
|
4.7%
3/64 • Number of events 3 • 31 days post-operatively
|
0.00%
0/67 • 31 days post-operatively
|
0.00%
0/2 • 31 days post-operatively
|
|
Gastrointestinal disorders
constipation
|
3.1%
2/64 • Number of events 2 • 31 days post-operatively
|
1.5%
1/67 • Number of events 1 • 31 days post-operatively
|
0.00%
0/2 • 31 days post-operatively
|
|
Surgical and medical procedures
increased post operative pain
|
7.8%
5/64 • Number of events 5 • 31 days post-operatively
|
3.0%
2/67 • Number of events 2 • 31 days post-operatively
|
0.00%
0/2 • 31 days post-operatively
|
|
Skin and subcutaneous tissue disorders
delayed wound healing/wound dehiscence
|
0.00%
0/64 • 31 days post-operatively
|
1.5%
1/67 • Number of events 1 • 31 days post-operatively
|
0.00%
0/2 • 31 days post-operatively
|
|
Infections and infestations
Surgical Site Infection
|
0.00%
0/64 • 31 days post-operatively
|
3.0%
2/67 • Number of events 2 • 31 days post-operatively
|
0.00%
0/2 • 31 days post-operatively
|
|
Infections and infestations
Viral Infection
|
1.6%
1/64 • Number of events 1 • 31 days post-operatively
|
0.00%
0/67 • 31 days post-operatively
|
0.00%
0/2 • 31 days post-operatively
|
|
Infections and infestations
Urinary Tract Infection
|
3.1%
2/64 • Number of events 2 • 31 days post-operatively
|
0.00%
0/67 • 31 days post-operatively
|
0.00%
0/2 • 31 days post-operatively
|
|
Musculoskeletal and connective tissue disorders
Calf Pain
|
4.7%
3/64 • Number of events 3 • 31 days post-operatively
|
0.00%
0/67 • 31 days post-operatively
|
0.00%
0/2 • 31 days post-operatively
|
|
Immune system disorders
Hives/pruritus
|
1.6%
1/64 • Number of events 1 • 31 days post-operatively
|
0.00%
0/67 • 31 days post-operatively
|
0.00%
0/2 • 31 days post-operatively
|
|
Nervous system disorders
Altered Mental Status
|
1.6%
1/64 • Number of events 1 • 31 days post-operatively
|
0.00%
0/67 • 31 days post-operatively
|
0.00%
0/2 • 31 days post-operatively
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
1.6%
1/64 • Number of events 1 • 31 days post-operatively
|
0.00%
0/67 • 31 days post-operatively
|
0.00%
0/2 • 31 days post-operatively
|
|
Musculoskeletal and connective tissue disorders
Gout Flare
|
0.00%
0/64 • 31 days post-operatively
|
1.5%
1/67 • Number of events 1 • 31 days post-operatively
|
0.00%
0/2 • 31 days post-operatively
|
|
General disorders
Fatigue
|
1.6%
1/64 • Number of events 1 • 31 days post-operatively
|
0.00%
0/67 • 31 days post-operatively
|
0.00%
0/2 • 31 days post-operatively
|
|
Gastrointestinal disorders
GI Bleed
|
1.6%
1/64 • Number of events 1 • 31 days post-operatively
|
0.00%
0/67 • 31 days post-operatively
|
0.00%
0/2 • 31 days post-operatively
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place