Prevention of Post Operative Urinary Retention After Thoracic Surgery Trial

NCT ID: NCT06262048

Last Updated: 2024-10-28

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

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2026-02-01

Brief Summary

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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

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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.

Conditions

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Urinary Retention Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

single centre, double blind randomized controlled trial
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Treatment

Tamsulosin

Group Type EXPERIMENTAL

Tamsulosin Hydrochloride

Intervention Type DRUG

2 days pre-op, day of surgery, 2 days post-op

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

2 days pre-op, day of surgery, 2 days post-op

Interventions

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Tamsulosin Hydrochloride

2 days pre-op, day of surgery, 2 days post-op

Intervention Type DRUG

Placebo

2 days pre-op, day of surgery, 2 days post-op

Intervention Type OTHER

Other Intervention Names

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tamsulosin HCL

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

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Rahul Nayak

MD MSc FRCSC

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rahul Nayal

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Locations

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London Health Sciences Centre

London, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Deb Lewis

Role: CONTACT

519-685-8500 ext. 75685

Facility Contacts

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Rahul Nayak, MD MSc

Role: primary

519-685-8500 ext. 56927

Other Identifiers

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PrePOURTS

Identifier Type: -

Identifier Source: org_study_id

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