Tamsulosin to Prevent Postoperative Urinary Retention in Laparoscopic Inguinal Hernia Repair

Phase 4

Terminated

• Conditions: Post Operative Urinary Retention
• Interventions: Drug: Placebo; Drug: Tamsulosin

• Registration Number: NCT04434378
• Lead Sponsor: Jewish Hospital, Cincinnati, Ohio

Brief 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.

Study Timeline

• Study Start: 2017-11-16
• Primary Completion: 2020-02-05
• Study Completion: 2020-02-05
• Status Verified: 2020-06
• Study First Submitted: 2020-06-12
• Study First Submitted QC: 2020-06-15
• Last Update Submitted: 2020-06-15
• Study First Posted: 2020-06-16
• Last Update Posted: 2020-06-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

1. All patients undergoing elective laparoscopic inguinal hernia repair, unilateral or bilateral.
2. ≥18 years of age.
3. Patients must leave the operating room without at indwelling urinary catheter.

Exclusion Criteria

1. History of neurogenic bladder requiring routine intermittent catheterization
2. Emergent laparoscopic hernia repair.
3. Elective laparoscopic hernia repair in conjuncture with an additional operation (e.g. nephrectomy, pelvic surgery) that requires the patient to have a planned, indwelling urinary catheter in the postoperative period.
4. Pregnant women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patients undergoing laparoscopic inguinal hernia repair will randomized to one dose of placebo in the preoperative holding area 2 hours before surgery.
Interventional	Tamsulosin	Patients undergoing laparoscopic inguinal hernia repair will be randomized to one dose of 0.4 mg tamsulosin in the preoperative holding area 2 hours before surgery.

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative urinary retention.	Within 24 hours of surgery	Patients undergoing laparoscopic inguinal hernia repair will be assessed for postoperative urinary retention in the post anesthesia care unit. Postoperative urinary retention 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).

Secondary Outcome Measures

Name	Time	Method
Incidence of risk factors for postoperative urinary retention in patients undergoing laparoscopic inguinal hernia repair.	within 24 hours of surgery	Retrospective chart review will be utilized to asses the incidence of risk factors of postoperative urinary retention in patients undergoing laparoscopic inguinal hernia repair. Risk factors including age \>60, total IV fluids, length of procedure, opioid use, bilateral vs unilateral repair, BMI \>30, diabetes mellitus, coronary artery disease, and benign prostatic hyperplasia will be assessed. These risk factors will then undergo statistical analysis to determine if they are associated with postoperative urinary retention.

Trial Locations

Locations (1)

Jewish Hospital; 🇺🇸 Cincinnati, Ohio, United States