Tamsulosin to Prevent Postoperative Urinary Retention in Laparoscopic Inguinal Hernia Repair

Jewish Hospital, Cincinnati, Ohio

Status and phase: Terminated; Phase 4

Conditions: Post Operative Urinary Retention

Treatments: Drug: Placebo; Drug: Tamsulosin

Study type: Interventional

Funder types: Other

Identifiers

NCT04434378

17-19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 170 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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170 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Patients undergoing laparoscopic inguinal hernia repair will randomized to one dose of placebo in the preoperative holding area 2 hours before surgery.

Treatment:

Drug: Placebo

Interventional

Experimental group

Description:

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.

Treatment:

Drug: Tamsulosin