Hernia, Urinary Retention
Conditions
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.
Interventions
DRUGTamsulosin
Tamsulosin treatment for 7 days pre-operatively
Sponsors
Memorial Health University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Randomization to 1 of 2 possible arms, control and treatment
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative urinary retention | 2 weeks | Incidence of post-operative urinary retention in patients undergoing hernia repair |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of IPSS | 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) |
Countries
United States
Contacts
Primary ContactVishu Danthuluri, M.D.
Backup ContactAndrew Schwemmer, M.D.
Outcome results
None listed