NCT04434378

Tamsulosin to Prevent Postoperative Urinary Retention in Laparoscopic Inguinal Hernia Repair

The Use of Tamsulosin to Prevent Postoperative Urinary Retention in Laparoscopic Inguinal Hernia Repair: A Randomized Double-Blind Placebo-Controlled Study

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: Jewish Hospital, Cincinnati, Ohio · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To investigate the effect of tamsulosin on the development of post-operative urinary retention (PUR) after elective laparoscopic inguinal hernia repair (LIHR). This will be accomplished by administering a pre-operative dose of tamsulosin. The primary outcome is the rate of urinary retention necessitating straight catheterization or insertion of foley catheter prior to discharge.

Detailed description

Patients who are scheduled for elective laparoscopic inguinal hernia repair will be consented in the office by the attending physician. An order will be placed during surgery scheduling for tamsulosin with instruction to administer one dose in the preoperative holding area on the day of surgery. The Jewish hospital pharmacy will be responsible for providing randomization and placebo medications for double blinding effect. PUR will be tracked on the basis of urinary catheterization performed prior to hospital discharge. Criteria for catheterization include: i) Inability to urinate within 6 hours post-operatively, and bladder scan showing \>400 mL. ii) Inability to urinate at any time postoperatively with symptoms of urinary retention (i.e. urgency, bladder discomfort). Women of childbearing age will need to have a confirmed negative urine or serum pregnancy test prior to surgery. This will be completed on arrival to the preoperative holding area. To detect the difference between the treated group and control group with a significant alpha (0.5) and power (80%), at least 178 patients will be needed in each group. This was generated using the Pearson Chi-square test for Two proportions. This study will be conducted in the hospital setting at a single institution. Patients will be consented for the study in the pre-admission holding area and followed until discharged from the post anesthesia care unit.

Conditions

• Post Operative Urinary Retention

Interventions

Type	Name	Description
DRUG	Tamsulosin	0.4 mg tamsulosin will be given to a randomized group of patients
DRUG	Placebo	placebo will be given to a randomized group of patients

Timeline

• Start date: 2017-11-16
• Primary completion: 2020-02-05
• Completion: 2020-02-05
• First posted: 2020-06-16
• Last updated: 2020-06-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study