Prevention of Post Operative Urinary Retention After Thoracic Surgery Trial

Urinary Retention Postoperative Clinical Trial

— PrePOURTS  

Official title:

Prevention of Post Operative Urinary Retention After Thoracic Surgery: A Phase II Feasbility Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06262048
• Other study ID #: PrePOURTS
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 1, 2024
• Est. completion date: May 31, 2025

Study information

• Verified date: May 2024
• Source: Lawson Health Research Institute
• Contact: Deb Lewis
• Phone: 519-685-8500
• Email: deb.lewis[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 31, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urinary Retention
• Urinary Retention Postoperative

Intervention

Drug:
• Tamsulosin Hydrochloride
2 days pre-op, day of surgery, 2 days post-op

Other:
• Placebo
2 days pre-op, day of surgery, 2 days post-op

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrollment Effectiveness	Percentage of Screen eligible patients consenting to the study	4 months
Primary	Monthly recruitment	Rate of monthly recruitment	4 months
Primary	Protocol adherence	Percentage of enrolled patient adherent to protocol during intervention phase	4 Months
Secondary	Rate of Straight Catheterizations	Number of Single urinary catheterizations performed	30 days post-op
Secondary	Rate of Indwelling Catheterizations	Proportion of patients who have an indwelling foley catheter inserted during their post-operative stay	30 days post-op
Secondary	Time to first catheterization	Time to first catheterization	up to 30 days post-op
Secondary	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.	30 days post-op
Secondary	Catheter related complications	Rates of catheter related complications within 30 days of catheterization (e.g. CAUTI, Urethral Trauma, Hematuria, urethral stricture)	30 days post-op
Secondary	Length of stay	Duration of hospital length of stay will be measured by collecting the date of admission and the date of discharge	30 days post-op