- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03027115
Hernia Surgery Urinary Retention
March 21, 2018 updated by: Memorial Health University Medical Center
Post-operative Urinary Retention: A Prospective Randomized Study Identifying Patients at Risk and Reducing the Incidence Using Tamsulosin Pretreatment
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.
Study Overview
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 Type
Interventional
Enrollment (Anticipated)
140
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Georgia
-
Savannah, Georgia, United States, 31404
- Recruiting
- Memorial Health University Medical Center
-
Contact:
- Andrew Schwemmer, M.D.
- Email: SchweAn2@memorialhealth.com
-
Contact:
- Vishu Danthuluri, M.D.
- Phone Number: 256-665-5214
- Email: vishwanathdanthuluri@memorialhealth.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Treatment
treatment with a selective alpha1-adrenoceptor antagonist
|
Tamsulosin treatment for 7 days pre-operatively
Other Names:
|
NO_INTERVENTION: Control
no treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-operative urinary retention
Time Frame: 2 weeks
|
Incidence of post-operative urinary retention in patients undergoing hernia repair
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of IPSS
Time Frame: 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)
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 13, 2017
Primary Completion (ANTICIPATED)
January 13, 2020
Study Completion (ANTICIPATED)
January 27, 2020
Study Registration Dates
First Submitted
January 18, 2017
First Submitted That Met QC Criteria
January 18, 2017
First Posted (ESTIMATE)
January 20, 2017
Study Record Updates
Last Update Posted (ACTUAL)
March 23, 2018
Last Update Submitted That Met QC Criteria
March 21, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urologic Diseases
- Urination Disorders
- Pathological Conditions, Anatomical
- Hernia
- Urinary Retention
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Urological Agents
- Adrenergic alpha-1 Receptor Antagonists
- Adrenergic alpha-Antagonists
- Tamsulosin
Other Study ID Numbers
- MHUMC 2016.10.05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is no plan to share IPD.
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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