Study to Prevent Postoperative Urinary Retention

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: Male

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 empty one's bladder following surgery. It is usually self-limited, but it requires the use of catheterization to empty the bladder in order to prevent further injury to the bladder or kidneys and to relief the discomfort of a full bladder. Tamsulosin is a medication that is commonly used in men with urinary symptoms related to an enlarged prostate. There is some evidence to suggest that it may also potentially be beneficial for preventing post-operative urinary retention.

The purpose of this study is to determine if tamsulosin ("TAMSULOSIN Mepha Ret Depocaps 0.4 mg") is effective in preventing post-operative urinary retention following endoscopic total extraperitoneal inguinal hernia repair and its impact on hospital length of stay.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Antonio Nocito, MD
• Collaborator: Becton, Dickinson and Company
• Treatments: Tamsulosin

Criteria

Inclusion Criteria:

• 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 Criteria:

• Orthostatic hypotension

• 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