Thoracic Diseases, Urinary Retention
Conditions
Brief summary
Post-Operative Urinary Retention (POUR) in Thoracic Surgery is a prospective interventional study aiming to test the hypothesis that the prophylactic use of tamsulosin prior to thoracic surgery in high risk patients leads to reduce the rates of POUR.
Detailed description
Post-operative urinary retention (POUR) is one of the most common post-operative complications encountered by most surgical specialties. The incidence of POUR can vary from five to 70%. Post-operative urinary retention is a prevalent complication. Patients who undergo thoracic surgery have greater urinary retention rates compared to others. Data on effective methods to reduce the risk of POUR in this high-risk group are limited. All subjects who meet inclusion and exclusion criteria will be invited to participate. There will be no randomization. All will receive tamsulosin in the pre operative period.
Interventions
0.4mg orally nightly for the two days immediately prior to surgery and the morning of surgery.
Sponsors
University of Massachusetts, Worcester
UMass Memorial Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All subjects that sign a study consent and meet inclusion and exclusion criteria will receive the the study drug.
Eligibility
Sex/Gender
MALE
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All male patients \>=60 years old who undergo inpatient thoracic surgery for major resections.
Exclusion criteria
* \- Prisoners * Adults unable to consent * End stage renal disease on hemodialysis * Indwelling urinary catheter * Child-Pugh class C hepatic failure * Usage of the following medications prior to surgery: strong CYP 3A4 inhibitors, strong CYP2D6 inhibitors, other alpha-adrenergic blocking agents, PDE5 inhibitors, and cimetidine * patients known to be CYP2D6 poor metabolizers * History of prostatectomy or cystectomy * Patients with contraindications to tamsulosin and those at high risk for side effects: hypersensitivity to tamsulosin HCl or any component of FLOMAX capsules, hypersensitivity to sulfonamides. History of known glaucoma, hypotension, plan to undergo cataract surgery in the next 2 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Post-Operative Urinary Retention (Pour) | 5 days | Proportion of Participants experiencing Post-Operative Urinary Retention (POUR) following thoracic surgery as compared to historic controls. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Perioperative Tamsulosin Hydrochloride Participants undergoing thoracic surgery will receive 0.4mgTamsulosin Hydrochloride orally nightly for the two nights immediately prior to surgery and the morning of surgery.
Tamsulosin Hydrochloride: 0.4mg orally nightly for the two days immediately prior to surgery and the morning of surgery. | 7 |
| Historical Comparator Participants who underwent thoracic surgery (historical). Information about occurrence of Peri-Operative Urinary Retention in thoracic surgery patients will be obtained via retrospective chart review. | 101 |
| Total | 108 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
Baseline characteristics
| Characteristic | Historical Comparator | Total | Perioperative Tamsulosin Hydrochloride |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 74 Participants | 79 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 29 Participants | 2 Participants |
| Age, Continuous | 70 years STANDARD_DEVIATION 7 | 70 years STANDARD_DEVIATION 7 | 70 years STANDARD_DEVIATION 8 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 101 participants | 108 participants | 7 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 101 Participants | 108 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 101 |
| other Total, other adverse events | 0 / 7 | 0 / 101 |
| serious Total, serious adverse events | 1 / 7 | 0 / 101 |
Outcome results
Primary
Participants With Post-Operative Urinary Retention (Pour)
Proportion of Participants experiencing Post-Operative Urinary Retention (POUR) following thoracic surgery as compared to historic controls.
Time frame: 5 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Perioperative Tamsulosin Hydrochloride | Participants With Post-Operative Urinary Retention (Pour) | 1 participants |
| Historical Comparator | Participants With Post-Operative Urinary Retention (Pour) | 32 participants |