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

NCT02958878 | Completed Phase 4

• 1 other identifier: GenesysRMC
• Study Type: interventional
• Target: 210
• Locations: 0 countries
• Sites: N/A

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

Conditions

Postoperative Urinary Retention

Outcome Measures

Primary Outcomes (1)

• number of Urinary Retention

  If patients have urinary retention post operatively

  within 72 hours of surgery

Secondary Outcomes (1)

• placebo vs tamsulosin

  within 72 hours of surgery

Study Arms (2)

A

EXPERIMENTAL

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

Drug: Tamsulosin

B

PLACEBO COMPARATOR

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

Drug: Placebo Oral Capsule

Interventions

Tamsulosin DRUG

Also known as: Flomax

A

Placebo Oral Capsule DRUG

B

Eligibility Criteria

• Age: 30 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ascension Health: lead

MeSH Terms

Interventions

Tamsulosin

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General Surgery Resident

Study Record Dates

• First Submitted: November 5, 2016
• First Posted: November 8, 2016
• Study Start: January 3, 2017
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: July 30, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share