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

Phase 4

Completed

• Conditions: Postoperative Urinary Retention
• Interventions: Drug: Tamsulosin; Drug: Placebo Oral Capsule

• Registration Number: NCT02958878
• Lead Sponsor: Ascension Health

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-05
• Study First Submitted QC: 2016-11-05
• Study First Posted: 2016-11-08
• Study Start: 2017-01-03
• Primary Completion: 2018-11-30
• Study Completion: 2018-11-30
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-29
• Last Update Posted: 2019-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 210

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Tamsulosin	Tamsulosin 0.4mg given the night before surgery and another dose the day of surgery in the morning.
B	Placebo Oral Capsule	Placebo medication given the night before surgery and another dose the day of surgery in the morning

Primary Outcome Measures

Name	Time	Method
number of Urinary Retention	within 72 hours of surgery	If patients have urinary retention post operatively

Secondary Outcome Measures

Name	Time	Method
placebo vs tamsulosin	within 72 hours of surgery