Tamsulosin vs Placebo to Prevent Postoperative Urinary Retention in Female Pelvic Reconstructive Surgery

University Hospitals (UH)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Urinary Retention; Lower Urinary Tract Symptoms; Stress Urinary Incontinence; Pelvic Organ Prolapse

Treatments: Drug: Tamsulosin; Drug: Placebo oral capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT03524339

Tamsulosin for POUR

Details and patient eligibility

About

This is a placebo controlled randomized controlled trial of perioperative use of tamsulosin to prevent postoperative urinary retention in female pelvic reconstructive surgery.

Enrollment: 132 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients must be 18 years or older as well as willing and able to provide informed consent
• Patients must be undergoing a scheduled surgery for pelvic organ prolapse or urinary incontinence
• Standard postoperative plan must include admission to the hospital with foley catheterization overnight the night after surgery, and planned removal of foley catheter and active voiding trial on postoperative day 1.

Exclusion criteria

• Patient unable or unwilling to provide informed consent
• Severe allergy to sulfa drugs
• Known allergy to tamsulosin or another alpha antagonist medication
• History of urinary retention
• Planned bladder catheterization greater than 24 hours after surgery
• Current use of alpha antagonist medication for hypertension
• End stage renal or liver disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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132 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo oral capsule

Tamsulosin

Experimental group

Treatment:

Drug: Tamsulosin