Hernia Surgery Urinary Retention

Phase 4

• Conditions: Hernia; Urinary Retention
• Interventions: Drug: Tamsulosin

• Registration Number: NCT03027115
• Lead Sponsor: Memorial Health University Medical Center

Brief Summary

Investigating whether pre-operative treatment with a selective alpha1-adrenoceptor antagonist affects the likelihood of male patients developing post-operative urinary retention following hernia repair.

Detailed Description

The purpose of this study will be to investigate whether pre-operative treatment with a selective alpha1-adrenoceptor antagonist affects the likelihood of male patients developing post-operative urinary retention following hernia repair surgery. It is also of interest to determine whether or not a well-known urological screening tool, the IPSS, can identify patients at risk for urinary retention following elective laparoscopic or open hernia repair surgery. We will investigate if it is possible to pre-treat patients with a selective alpha1-adrenoceptor antagonist which we think can reduce the incidence of post-operative urinary retention and the associated adverse consequences, especially in those patients at higher risk.

Study Timeline

• Study Start: 2017-01-13
• Study First Submitted: 2017-01-18
• Study First Submitted QC: 2017-01-18
• Study First Posted: 2017-01-20
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-21
• Last Update Posted: 2018-03-23
• Primary Completion: 2020-01-13
• Study Completion: 2020-01-27

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 140

Inclusion Criteria

• Male
• 18 years of age
• Presenting with hernia requiring surgical intervention

Exclusion Criteria

• Intolerability of tamsulosin or related drugs
• Investigator discretion
• Unwillingness or inability to comply with protocol procedures and assessments

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Tamsulosin	treatment with a selective alpha1-adrenoceptor antagonist

Primary Outcome Measures

Name	Time	Method
Post-operative urinary retention	2 weeks	Incidence of post-operative urinary retention in patients undergoing hernia repair

Secondary Outcome Measures

Name	Time	Method
Effect of IPSS	2 weeks	the variance in the relationship between treatment arm and incidence of post-operative urinary retention in patients undergoing hernia repair that is attributable to International Prostate Symptom Score (IPSS)

Trial Locations

Locations (1)

Memorial Health University Medical Center; 🇺🇸 Savannah, Georgia, United States