Prevention of Post Operative Urinary Retention After Thoracic Surgery Trial

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male Sex

Age greater than or equal to 40 years

History of Diabetes Mellitus

Prior pelvic irradiation

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tamsulosin Hydrochloride

    Drug

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

  • Placebo

    Other intervention

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: TreatmentExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Enrollment Effectiveness

Percentage of Screen eligible patients consenting to the study

Time frame
4 months
2

Monthly recruitment

Rate of monthly recruitment

Time frame
4 months
3

Protocol adherence

Percentage of enrolled patient adherent to protocol during intervention phase

Time frame
4 Months

Secondary outcomes

1

Rate of Straight Catheterizations

Number of Single urinary catheterizations performed

Time frame
30 days post-op
2

Rate of Indwelling Catheterizations

Proportion of patients who have an indwelling foley catheter inserted during their post-operative stay

Time frame
30 days post-op
3

Time to first catheterization

Time to first catheterization

Time frame
up to 30 days post-op
4

Treatment Related Adverse Events

Unexpected or noxious events that occur as a result of or suspected to be a result of use of the study drug.

Time frame
30 days post-op

Other outcomes

Sponsors and contacts

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