Impact of Tamsulosin on Post-Operative Urinary Retention Following Pelvic Reconstructive Surgery
Purpose
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.
Condition
- Urinary Retention Postoperative
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Female
- Accepts 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 last 6 months
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Tamsulosin |
10 capsules will be distributed to subjects to be taken daily. Each capsule contains 0.4mg of Tamsulosin. Subjects will take the capsule once daily until the end of the 10 day course or until the resolution of acute postoperative urinary retention. Both study drug and placebo will appear identical and will be prepared by the pharmacy. |
|
|
Placebo Comparator Placebo |
10 capsules will be distributed to subjects to be taken daily. Subjects will take the capsule once daily until the end of the 10 day course or until the resolution of acute postoperative urinary retention. Both study drug and placebo will appear identical and will be prepared by the pharmacy. |
|
Recruiting Locations
Pittsburgh 5206379, Pennsylvania 6254927 15224
More Details
- NCT ID
- NCT04597372
- Status
- Recruiting
- Sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Detailed 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 placebo. The Euroqol-5D (EQ-5D) will be used to compare physical, emotional, functional, and social/family well-being between women receiving Tamsulosin and placebo. Upon diagnosis of POUR, women will be offered participation in the study. Once consent is obtained, women will be randomized to tamsulosin 0.4 mg or matching placebo capsules to be used daily until resolution of POUR or a 10 day course, whichever occurs first.