Preoperative Administration of Tamsulosin for Prevention of Post Operative Urinary Retention in Males Undergoing Elective Inguinal Hernia Repair

Ascension Health

Status and phase: Completed; Phase 4

Conditions: Postoperative Urinary Retention

Treatments: Drug: Tamsulosin; Drug: Placebo Oral Capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT02958878

GenesysRMC

Details and patient eligibility

About

Double blinded, randomized controlled prospective study looking at 2 preoperative doses of Tamsulosin an alpha-adrenergic blocker in preventing post-operative urinary retention. A previous study was conducted called "Effectiveness of tamsulosin inprevention of postoperative urinary retention: a randomized double-blind-placebo controlled study" This study involved a tertiary care center involving mostly urological surgical procedures. We look to specifically look at inguinal hernia surgeries in males. The aim of this study is to compare the prophylactic effect of tamsulosin with placebo on postoperative urinary retention. The drug is FDA approved for benign prostatic hypertrophy and urinary retention. It is on formulary at Genesys. Currently there is no standard procedure of prophylactic tamsulosin for urinary retention. Most often post operative patients are given tamsulosin to augment smooth muscle relaxation and spontaneous voiding if the patient is having urinary retention post operatively. We often straight catheterize patients once and start tamsulosin with the goal of avoiding urinary retention and future straight catheterizations or placement of foley catheters

Enrollment: 210 patients

Sex: Male

Ages: 30+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy males, who are not taking Tamsulosin regularly who are undergoing elective inguinal hernia repair (laparoscopic, open, and robotic assisted)

Exclusion criteria

• Patients who are already taking tamsulosin, terazosin (alpha blocker treatement for BPH) , finasteride, dutasteride ( both 5 alpha reductase inhibitors), sulfa allergy, and lactose allergy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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210 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

Tamsulosin 0.4mg given the night before surgery and another dose the day of surgery in the morning.

Treatment:

Drug: Tamsulosin

B

Placebo Comparator group

Description:

Placebo medication given the night before surgery and another dose the day of surgery in the morning

Treatment:

Drug: Placebo Oral Capsule