Hernia Surgery Urinary Retention

Urinary Retention Clinical Trial

Official title:

Post-operative Urinary Retention: A Prospective Randomized Study Identifying Patients at Risk and Reducing the Incidence Using Tamsulosin Pretreatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03027115
• Other study ID #: MHUMC 2016.10.05
• Status: Recruiting
• Phase: Phase 4
• First received: January 18, 2017
• Last updated: March 21, 2018
• Start date: January 13, 2017
• Est. completion date: January 27, 2020

Study information

• Verified date: March 2018
• Source: Memorial Health University Medical Center
• Contact: Vishu Danthuluri, M.D.
• Phone: 256.665-6214
• Email: vishwanathdanthuluri[@]memorialhealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: January 27, 2020
• Est. primary completion date: January 13, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Urinary Retention

Intervention

Drug:
• Tamsulosin
Tamsulosin treatment for 7 days pre-operatively

Locations

Country	Name	City	State
United States	Memorial Health University Medical Center	Savannah	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Health University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative urinary retention	Incidence of post-operative urinary retention in patients undergoing hernia repair	2 weeks
Secondary	Effect of IPSS	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)	2 weeks