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

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.

Study Overview

• Status: Terminated
• Conditions: Post Operative Urinary Retention
• Intervention / Treatment: Drug: Placebo; Drug: Tamsulosin

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 Type: Interventional
• Enrollment (Actual): 170
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45236
      • Jewish Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Patients undergoing laparoscopic inguinal hernia repair will randomized to one dose of placebo in the preoperative holding area 2 hours before surgery.	Drug: Placebo; placebo will be given to a randomized group of patients
Experimental: Interventional; 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.	Drug: Tamsulosin; 0.4 mg tamsulosin will be given to a randomized group of patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative urinary retention.	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).	Within 24 hours of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of risk factors for postoperative urinary retention in patients undergoing laparoscopic inguinal hernia repair.	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.	within 24 hours of surgery

Collaborators and Investigators

• Sponsor: Jewish Hospital, Cincinnati, Ohio

Publications and helpful links

General Publications

• Sivasankaran MV, Pham T, Divino CM. Incidence and risk factors for urinary retention following laparoscopic inguinal hernia repair. Am J Surg. 2014 Feb;207(2):288-92. doi: 10.1016/j.amjsurg.2013.06.005. Epub 2013 Nov 5.
• Garg P, Rajagopal M, Varghese V, Ismail M. Laparoscopic total extraperitoneal inguinal hernia repair with nonfixation of the mesh for 1,692 hernias. Surg Endosc. 2009 Jun;23(6):1241-5. doi: 10.1007/s00464-008-0137-0. Epub 2008 Sep 24.
• Mohammadi-Fallah M, Hamedanchi S, Tayyebi-Azar A. Preventive effect of tamsulosin on postoperative urinary retention. Korean J Urol. 2012 Jun;53(6):419-23. doi: 10.4111/kju.2012.53.6.419. Epub 2012 Jun 19.
• Shaw MK, Pahari H. The role of peri-operative use of alpha-blocker in preventing lower urinary tract symptoms in high risk patients of urinary retention undergoing inguinal hernia repair in males above 50 years. J Indian Med Assoc. 2014 Jan;112(1):13-4, 16.

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2017
• Primary Completion (Actual): February 5, 2020
• Study Completion (Actual): February 5, 2020

Study Registration Dates

• First Submitted: June 12, 2020
• First Submitted That Met QC Criteria: June 15, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Actual): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 15, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: tamsulosin; laparoscopic inguinal hernia repair
• Additional Relevant MeSH Terms: Urologic Diseases; Urination Disorders; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal; Urinary Retention; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Tamsulosin
• Other Study ID Numbers: 17-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes