Recruiting

Observational Study

Sponsor:

Memorial Health University Medical Center

Code:

NCT03027115

Conditions

Hernia

Urinary Retention

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tamsulosin

Study Details

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.

Conditions

Hernia

Urinary Retention

Study ID

NCT03027115

Start date

Jan 13, 2017

Status verified date

Mar, 2018

Completion date

Jan 27, 2020

Anticipated

Primary completion date

Jan 13, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Treatment

treatment with a selective alpha1-adrenoceptor antagonist

no intervention: Control

no treatment

Interventions

Tamsulosin

Tamsulosin treatment for 7 days pre-operatively

Primary outcome measure

  • Post-operative urinary retention [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Vishu Danthuluri, M.D.

256.665-6214vishwanathdanthuluri@memorialhealth.com

Andrew Schwemmer, M.D.

SchweAn2@memorialhealth.com

Locations

Memorial Health University Medical Center

Recruiting

Savannah, Georgia, United States, 31404

Contacts

Vishu Danthuluri, M.D.

256-665-5214vishwanathdanthuluri@memorialhealth.com

Andrew Schwemmer, M.D.

SchweAn2@memorialhealth.com

More Information

Sponsor

Memorial Health University Medical Center

Last update posted

Mar 23, 2018

Last verified

Mar, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Health University Medical Center on 2018-03-23.