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

University Hospitals (UH) logo

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

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

Trial documents
1

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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