Preventing urinary retention after inguinal hernia repair
Randomized, Quadruple Blinded, Placebo Controlled, Multi-centered Trial Investigating Prophylactic Tamsulosin in Prevention of Postoperative Urinary Retention in Men After Endoscopic Total Extraperitoneal Inguinal Hernia Repair
This study is testing if a medication called tamsulosin can help prevent urinary problems after inguinal hernia surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 634 (estimated) |
| Ages | 60 Years and up |
| Sex | Male |
| Sponsor | Kantonsspital Baden Academic / other |
| Locations | 1 site (Baden, Aargau) |
| Trial ID | NCT04491526 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of tamsulosin, a medication commonly used for urinary symptoms, in preventing postoperative urinary retention (POUR) following endoscopic total extraperitoneal inguinal hernia repair. Participants will be randomly assigned to receive either tamsulosin or a placebo for a total of seven days, starting five days before surgery. The study employs a double-blind, randomized controlled design to ensure unbiased results, with careful monitoring of participants' conditions and outcomes. The primary focus is on the incidence of POUR and its impact on hospital length of stay.
Who should consider this trial
Good fit: Ideal candidates for this study are males aged 60 and older who are scheduled for uni- or bilateral endoscopic total extraperitoneal inguinal hernia repair.
Not a fit: Patients with orthostatic hypotension, severe liver disease, or those currently taking alpha-blockers will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of postoperative urinary retention, improving patient comfort and potentially shortening hospital stays.
How similar studies have performed: Previous studies have shown promising results with similar approaches using tamsulosin for urinary retention, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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 (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
Where this trial is running
Baden, Aargau
- Kantonsspital Baden — Baden, Aargau, Switzerland (Recruiting)
Study contacts
- Principal investigator: Antonio Nocito, Prof — Kantonsspital Baden AG, Im Ergel 1, 5404 Baden, Switzerland
- Study coordinator: Uwe Bieri, MD
- Email: uwe.bieri@gmail.com
- Phone: +4179 268 78 37
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.