REduction of Post-Operative Urinary Retention With Tamsulosin Versus Placebo (REPOURT- P) Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-30

Study Completion Date

2023-12-31

Brief Summary

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The purpose of this study are to determine the efficacy of tamsulosin compared to placebo in reducing post-operative urinary retention and improving other clinical outcomes in people undergoing thoracic surgery.

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Detailed Description

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Post-operative urinary retention (POUR) is not an uncommon complication following thoracic surgery. It has been reported to occur in up to 12-67% of patients with the use of thoracic epidural analgesia1. Risk factors associated with urinary retention in thoracic patients include male, age over 40 years, type 2 diabetes, undergoing lung resection and the use of thoracic epidural analgesia2. Patients who experience urinary retention are treated with a straight catheter and may subsequently require the placement of an indwelling catheter. The use of these catheters is associated with numerous complications. The best studied complications are infectious and include catheter associated urinary tract infections (CAUTIs). However, many patients continue to experience symptoms well after their catheters have been removed.

Tamsulosin is an alpha one adrenergic receptor blocked that is indicated for the treatment of lower urinary tract symptoms in the context of benign prostatic hyperplasia. However, it is often used in clinical practice to treat other pathologies such as acute urinary retention and nephrolithiasis.

The objectives of this study are to determine the efficacy of tamsulosin compared to placebo in reducing post-operative urinary retention and catheter related complications in people undergoing thoracic surgery.

Conditions

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Urinary Catheterization Thoracic Surgery Thoracic Epidural Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tamsulosin Hydrochloride (HCL)

Consenting patients undergoing pulmonary resection will receive a 5-day allotment of tamsulosin HCL to be started 3 days prior to their date of surgery.

Group Type EXPERIMENTAL

Tamsulosin Hydrochloride

Intervention Type DRUG

Tamsulosin HCL is an alpha blocker. It relaxes the muscles in the prostate and bladder neck, making easier to urinate. The dosage used will be 0.4 mg (administered once daily)

Other names: Flomax

Placebo

Consenting patients undergoing pulmonary resection will receive a 5-day allotment of placebo to be started 3 days prior to their date of surgery.

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Half of the patients will be assigned to receive placebo tablets in the same manner as the active intervention. These tablets will have no effect.

Interventions

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Tamsulosin Hydrochloride

Tamsulosin HCL is an alpha blocker. It relaxes the muscles in the prostate and bladder neck, making easier to urinate. The dosage used will be 0.4 mg (administered once daily)

Other names: Flomax

Intervention Type DRUG

Placebos

Half of the patients will be assigned to receive placebo tablets in the same manner as the active intervention. These tablets will have no effect.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male patients greater than the age of 40 and/or with type 2 diabetes undergoing pulmonary surgery who did not undergo straight or indwelling urinary catheterization intraoperatively.

OR
2. Male patients receiving a thoracic epidural analgesia undergoing pulmonary surgery who did not undergo straight or indwelling urinary catheterization intraoperatively

Exclusion Criteria

1. Active treatment of Benign Prostatic Hyperplasia (BPH)
2. Hypersensitivity or allergy to tamsulosin HCL
3. Active treatment with tamsulosin or other alpha-blocker or uses of tamsulosin/ other alpha-blocker within 3 weeks of enrollment date
4. Active urinary tract infection
5. History of urological disorder specified as urethral stricture, BPH, bladder or prostate malignancy
6. History of urological surgery (Transurethral resection of the Prostate, Transurethral resection of the Bladder, Bladder suspension, prostatectomy)
7. Underlying neurological disorders resulting in impaired bladder function
8. Any known contraindication to the use of tamsulosin HCL

Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No