The Impact of Tamsulosin on Duration of Post-Operative Urinary Retention in Women Undergoing Pelvic Reconstructive Surgery- A Double Blind, Randomized, Placebo-Controlled Study
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Summary
The objective of the study is to determine the effectiveness of postoperative Tamsulosin in reducing the duration of acute postoperative urinary retention (POUR) following pelvic reconstructive surgery through a double blind, randomized placebo-controlled trial.
Description
The primary objective is to determine the impact of Tamsulosin on duration of urinary retention following pelvic reconstructive surgery in women. Duration of catheterization via indwelling foley or clean intermittent self-catheterization (CISC), measured in days, will be compared between women receiving Tamsulosin versus placebo after diagnosis of postoperative urinary retention via standardized voiding trial. It is hypothesized that women receiving Tamsulosin will have a shorter duration of urinary retention, fewer urinary tract infections, and improved quality of life as compared with placeb…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: * 18 years or older * willing and able to provide informed consent * postoperative urinary retention as defined by a failed RGVT prior to hospital discharge * Ability to speak and read English * Tolerate pill ingestion Exclusion Criteria: * allergy/intolerance to Tamsulosin or sulfa drugs * preoperative history of urinary retention as defined by preoperative post void residual of \>150mL * current use of alpha antagonist medication for hypertension * severe dementia * end stage renal or liver disease * history of severe heart failure or major cardiovascular event in the…
Interventions
- DrugTamsulosin
Study drug will contain 0.4 mg of Tamsulosin. Subjects will be provided with 10 capsules to be taken daily.
- DrugPlacebo
Placebo will be prepared by the IDS pharmacist (or contracted pharmacy) and encapsulated in identical appearing wraps. Subjects will be provided with 10 capsules to be taken daily.
Location
- West Penn HospitalPittsburgh, Pennsylvania