Status:
UNKNOWN
Study to Prevent Postoperative Urinary Retention
Lead Sponsor:
Antonio Nocito, MD
Conditions:
Urinary Retention
Inguinal Hernia
Eligibility:
MALE
60+ years
Phase:
PHASE4
Brief Summary
Post-operative urinary retention (POUR) is a common complication after inguinal hernia repair with a reported incidence up 34%. It can be described as the inability to initiate urination or properly e...
Detailed Description
In this RCT subjects are randomly and parallel assigned to one of two groups: one (the experimental group) receiving "Tamsulosin 0.4 mg"/ day, 5 days prior to the day of laparoscopic inguinal hernia r...
Eligibility Criteria
Inclusion
- Males
- ≥60 years old
- Planned uni- or bilateral endoscopic total extraperitoneal inguinal hernia repair
- Surgery scheduled more than 6 days from the time of consent
- Informed Consent as documented by signature (Appendix Informed Consent Form)
Exclusion
- Orthostatic hypotension (feeling of dizziness after getting up from a sitting or lying position)
- Severe liver disease (Child Pugh C)
- Taking strong inhibitors of CYP3A4 (ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir/ritonavir, lopinavir, or conivaptan)
- Being on alpha-blockers (alfuzosin, doxazosin, prazosin, terazosin, tamsulosin, phenoxybenzamine, or silodosin) or a combination product containing alpha-blocker (duodart)
- History of allergy or sensitivity to tamsulosin or other alpha-blockers (alfuzosin, doxazosin, prazosin, terazosin, or phenoxybenzamine)
- Long term Indwelling urinary or suprapubic catheter
- Status post cystectomy
- Inability to provide informed consent
- Known or suspected non-compliance, drug or alcohol abuse,
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- Participation in another study with investigational drug within the 30 days preceding and during the present study,
- Previous enrolment into the current study
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
634 Patients enrolled
Trial Details
Trial ID
NCT04491526
Start Date
November 1 2020
End Date
June 30 2025
Last Update
March 10 2023
Active Locations (1)
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1
Kantonsspital Baden
Baden, Canton of Aargau, Switzerland, 5404