RecruitingPhase 3NCT06843538

Peri-operative Tamsulosin and Impact on Voiding Trial After Same-day Urogynecology Surgery

Peri-operative Tamsulosin and Impact on Voiding Trial Following Outpatient Urogynecology Surgery: a Randomized Controlled Trial


Sponsor

TriHealth Inc.

Enrollment

166 participants

Start Date

Feb 3, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this research study is to determine if taking tamsulosin preoperatively decreases your chances of being discharged after surgery with a Foley catheter (flexible tube that drains urine from the bladder into a collection bag).


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria1

  • \- Patients undergoing any pelvic organ prolapse repair or incontinence surgery

Exclusion Criteria11

  • Any surgery involving a non-urogynecologist
  • Patients already on an alpha blocker
  • Baseline hypotension
  • History of syncope
  • Postural orthostatic tachycardia syndrome (POTS)
  • Non-English speaker or interpreter unavailable for Spanish-speaking patient
  • Impaired cognition impeding proper consenting
  • Any other medical contraindication for tamsulosin use
  • History of urinary retention requiring continuous or intermittent catheterization
  • Patients consented for the study but then due to intraoperative complication, routine voiding trial no longer indicated due to requiring indwelling catheter or intermittent catheterization on discharge will be excluded from primary outcome analysis
  • Pregnancy

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Interventions

DRUGTamsulosin

This intervention will investigate if tamsulosin will decrease postoperative urinary retention. Subjects will be directed to start taking the medication 5-7 days prior to their procedure; as previous studies have shown, this is when tamsulosin reaches its steady state. Patients will continue to take their assigned pills for 7 days postoperatively.

DRUGPlacebo

This intervention will ensure blinding and an accurate measure of the real effect of tamsulosin.


Locations(1)

TriHealth

Cincinnati, Ohio, United States

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NCT06843538


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