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OpenTrials
Completed

NCT Number: NCT02958878

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

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

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Key information

Age range

30 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tamsulosin

Drug

Other names: Flomax

Placebo oral capsule

Drug

Primary outcomes

  1. number of Urinary Retention

    Time frame: within 72 hours of surgery

    If patients have urinary retention post operatively

Secondary outcomes

  1. placebo vs tamsulosin

    Time frame: within 72 hours of surgery

Sponsors and collaborators

Lead sponsor

Ascension Health

Industry

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 8, 2016
Registry last updated
Jul 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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