Hernia Surgery Urinary Retention

NCT ID: NCT03027115

Last Updated: 2018-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-13

Study Completion Date

2020-01-27

Brief Summary

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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

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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.

Conditions

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Hernia Urinary Retention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomization to 1 of 2 possible arms, control and treatment
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Treatment

treatment with a selective alpha1-adrenoceptor antagonist

Group Type EXPERIMENTAL

Tamsulosin

Intervention Type DRUG

Tamsulosin treatment for 7 days pre-operatively

Control

no treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Tamsulosin

Tamsulosin treatment for 7 days pre-operatively

Intervention Type DRUG

Other Intervention Names

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Flomax

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Memorial Health University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Memorial Health University Medical Center

Savannah, Georgia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Vishu Danthuluri, M.D.

Role: CONTACT

256.665-6214

Andrew Schwemmer, M.D.

Role: CONTACT

Facility Contacts

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Vishu Danthuluri, M.D.

Role: primary

256-665-5214

Andrew Schwemmer, M.D.

Role: backup

Other Identifiers

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MHUMC 2016.10.05

Identifier Type: -

Identifier Source: org_study_id

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