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

• Sponsor: Ascension Genesys Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02958878
• Collaborator: (none)
• Enrollment: 210
• Arms: 2
• Actual Duration (Months): 22.9

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Postoperative Urinary Retention	Drug: Tamsulosin; Drug: Placebo Oral Capsule	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 210 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Preoperative Administration of Tamsulosin for Prevention of Post Operative Urinary Retention in Males Undergoing Elective Inguinal Hernia Repair
• Actual Study Start Date: Jan 3, 2017
• Actual Primary Completion Date: Nov 30, 2018
• Actual Study Completion Date: Nov 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A Tamsulosin 0.4mg given the night before surgery and another dose the day of surgery in the morning.	Drug: Tamsulosin; Other Names: Flomax
Placebo Comparator: B Placebo medication given the night before surgery and another dose the day of surgery in the morning	Drug: Placebo Oral Capsule

Outcome Measures

Primary Outcome Measures

1. number of Urinary Retention [within 72 hours of surgery]

   If patients have urinary retention post operatively

Secondary Outcome Measures

1. placebo vs tamsulosin [within 72 hours of surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Ascension Genesys Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anthony Tabatabai, General Surgery Resident, Ascension Genesys Hospital
• ClinicalTrials.gov Identifier: NCT02958878
• Other Study ID Numbers: GenesysRMC
• First Posted: Nov 8, 2016
• Last Update Posted: Jul 30, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Urinary Retention; Hernia, Inguinal; Tamsulosin

Study Results

No Results Posted as of Jul 30, 2019