Prevention of Post Operative Urinary Retention After Thoracic Surgery Trial (PrePOURTS)

Lawson Health Research Institute

Status and phase: Enrolling; Phase 2

Conditions: Urinary Retention Postoperative

Treatments: Drug: Tamsulosin Hydrochloride; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06262048

PrePOURTS

Details and patient eligibility

About

The objectives of this study are to determine the feasibility of conducting a full-scale randomized control trial comparing the efficacy of tamsulosin compared to placebo in reducing post-operative urinary retention in people undergoing elective thoracic surgery.

Full description

The objectives of this study are to determine the feasibility of conducting a full-scale randomized control trial comparing the efficacy of tamsulosin compared to placebo in reducing post-operative urinary retention in people undergoing elective thoracic surgery. Primary outcomes being measured are the enrollment rate, protocol adherence rate and participant drop out.

Enrollment: 60 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria ( 2 or more of the following risk factors):

• Male Sex
• Age greater than or equal to 40 years
• History of Diabetes Mellitus
• Prior pelvic irradiation
• Use of indwelling Thoracic Epidural analgesia
• Prior history of urinary retention

AND

International Prostate Specific Score greater than or equal to 1.

Exclusion Criteria:

• Active treatment of Benign Prostatic Hyperplasia (BPH)
• Hypersensitivity or allergy to tamsulosin HCL
• Active treatment with tamsulosin or other alpha-blocker or uses of tamsulosin/ other alpha-blocker within 3 weeks of enrollment date
• Active urinary tract infection
• History of urological disorder specified as urethral stricture, BPH, bladder or prostate malignancy.
• History of urological surgery (Transurethral resection of the Prostate, Transurethral resection of the Bladder, Bladder suspension, prostatectomy)
• Underlying neurological disorders resulting in impaired bladder function
• Any known contraindication to the use of tamsulosin HCL
• Nursing/ Breastfeeding women
• Use of intraoperative bladder catheter
• patients for whom cataract and/or glaucoma surgery is scheduled.
• patients on strong inhibitors of CYP3A4 (e.g., ketoconazole), on moderate inhibitors of CYP3A4 (e.g., erythromycin), on strong (e.g. paroxetine), on moderate (e.g., terbinafine) inhibitors of CYP2D6 or in patients known to be CYP2D6 poor metabolizers.
• patients with a serious or life-threatening sulfa allergy
• patients with severe hepatic insufficiency
• patients with severe renal impairment (creatinine clearance of <10 mL/min)
• patients with a serious or life-threatening sulfa allergy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Treatment

Experimental group

Description:

Tamsulosin

Treatment:

Drug: Tamsulosin Hydrochloride

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo