NCT03027115

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2017

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 20, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2020

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2020

Completed
Last Updated

March 23, 2018

Status Verified

March 1, 2018

Enrollment Period

3 years

First QC Date

January 18, 2017

Last Update Submit

March 21, 2018

Conditions

HerniaUrinary Retention

Outcome Measures

Primary Outcomes (1)

  • Post-operative urinary retention

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

    2 weeks

Secondary Outcomes (1)

  • Effect of IPSS

    2 weeks

Study Arms (2)

Treatment

EXPERIMENTAL

treatment with a selective alpha1-adrenoceptor antagonist

Drug: Tamsulosin

Control

NO INTERVENTION

no treatment

Interventions

TamsulosinDRUG

Tamsulosin treatment for 7 days pre-operatively

Also known as: Flomax
Treatment

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Health University Medical Center

Savannah, Georgia, 31404, United States

RECRUITING

MeSH Terms

Conditions

HerniaUrinary Retention

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur Compounds

Central Study Contacts

Vishu Danthuluri, M.D.

CONTACT

256.665-6214vishwanathdanthuluri@memorialhealth.com

Andrew Schwemmer, M.D.

CONTACT

SchweAn2@memorialhealth.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomization to 1 of 2 possible arms, control and treatment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2017

First Posted

January 20, 2017

Study Start

January 13, 2017

Primary Completion

January 13, 2020

Study Completion

January 27, 2020

Last Updated

March 23, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

There is no plan to share IPD.

Locations

US(1)