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Hernia Surgery Urinary Retention

Primary Purpose

Hernia, Urinary Retention

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tamsulosin
Sponsored by
Memorial Health University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hernia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Health University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment

Control

Arm Description

treatment with a selective alpha1-adrenoceptor antagonist

no treatment

Outcomes

Primary Outcome Measures

Post-operative urinary retention
Incidence of post-operative urinary retention in patients undergoing hernia repair

Secondary Outcome Measures

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)

Full Information

First Posted
January 18, 2017
Last Updated
March 21, 2018
Sponsor
Memorial Health University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03027115
Brief Title
Hernia Surgery Urinary Retention
Official Title
Post-operative Urinary Retention: A Prospective Randomized Study Identifying Patients at Risk and Reducing the Incidence Using Tamsulosin Pretreatment
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 13, 2017 (Actual)
Primary Completion Date
January 13, 2020 (Anticipated)
Study Completion Date
January 27, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Health University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Urinary Retention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomization to 1 of 2 possible arms, control and treatment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
treatment with a selective alpha1-adrenoceptor antagonist
Arm Title
Control
Arm Type
No Intervention
Arm Description
no treatment
Intervention Type
Drug
Intervention Name(s)
Tamsulosin
Other Intervention Name(s)
Flomax
Intervention Description
Tamsulosin treatment for 7 days pre-operatively
Primary Outcome Measure Information:
Title
Post-operative urinary retention
Description
Incidence of post-operative urinary retention in patients undergoing hernia repair
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Effect of IPSS
Description
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)
Time Frame
2 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vishu Danthuluri, M.D.
Phone
256.665-6214
Email
vishwanathdanthuluri@memorialhealth.com
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew Schwemmer, M.D.
Email
SchweAn2@memorialhealth.com
Facility Information:
Facility Name
Memorial Health University Medical Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vishu Danthuluri, M.D.
Phone
256-665-5214
Email
vishwanathdanthuluri@memorialhealth.com
First Name & Middle Initial & Last Name & Degree
Andrew Schwemmer, M.D.
Email
SchweAn2@memorialhealth.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share IPD.

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Hernia Surgery Urinary Retention

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