This is a double-blinded randomized controlled trial of perioperative use of tamsulosin to prevent postoperative urinary retention in female pelvic reconstructive surgery undergoing same-day discharge with an enhanced recovery after surgery protocol.
The primary objective is to determine the effect of Tamsulosin on same-day active voiding trial in women undergoing female pelvic reconstructive surgery with vaginal native tissue repair with same-day discharge planned. Duration of catheterization, postoperative urinary tract infection rates, patient level of satisfaction, Emergency Department (ED) visits and adverse events postoperatively will also be compared between women receiving Tamsulosin versus placebo. Patients will be offered participation in the study at their postoperative visit if they meet study criteria. Once consent is obtained, patients will be randomized to receive Tamsulosin 0.4 mg orally once daily or matching placebo capsules for a total of 10 days starting 5 days pre-operatively.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
4
Oral drug: 10 days of 0.4 mg of oral Tamsulosin
Oral drug: 10 days of identical-appearing placebo
Wake Forest Health Sciences
Winston-Salem, North Carolina, United States
Number of Participants With Postoperative (Day 0) Urinary Retention
Urinary retention can be defined as \>150cc residual volume during an active voiding trial
Time frame: Up to 6 weeks postoperatively
Urinary Tract Infection Rate
Urinary tract infection rate
Time frame: Week 6
Incidence of Delayed Urinary Retention
Delayed urinary retention will be defined as post-void residual \> 150 cc
Time frame: Week 6
Number Emergency Department (ED) Visits
Time frame: Up to 30 days postoperatively
Total Number of Days of Bladder Catheterization
Time frame: Week 6
Patient Level of Satisfaction With Voiding Function
Patient satisfaction questionnaire: Patient Global Impression of Improvement (PGI-I) - Patient level of satisfaction (scale of 1 -7) - very dissatisfied, moderately dissatisfied, slightly dissatisfied, neutral, slightly satisfied, moderately satisfied, very satisfied - the lower the score denotes the more satisfaction)
Time frame: Day 0 and 1 week postoperatively
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.