Clinical trial NCT06262048: Prevention of Post Operative Urinary Retention After Thoracic Surgery Trial
Official title: Prevention of Post Operative Urinary Retention After Thoracic Surgery: A Phase II Feasbility Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Urinary Retention Postoperative
Keywords: urinary retention
thoracic surgery
urinary catheter
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single centre, double blind randomized controlled trial
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Enrollment Effectiveness
timeFrame: 4 months
measure: Monthly recruitment
timeFrame: 4 months
measure: Protocol adherence
timeFrame: 4 Months
Secondary outcomes:
measure: Rate of Straight Catheterizations
timeFrame: 30 days post-op
measure: Rate of Indwelling Catheterizations
timeFrame: 30 days post-op
measure: Time to first catheterization
timeFrame: up to 30 days post-op
measure: Treatment Related Adverse Events
timeFrame: 30 days post-op
measure: Catheter related complications
timeFrame: 30 days post-op
measure: Length of stay
timeFrame: 30 days post-op
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Rahul Nayal
role: PRINCIPAL_INVESTIGATOR
References: