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

Purpose

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).

Condition

  • Postoperative Urinary Retention (POUR)

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients undergoing any pelvic organ prolapse repair or incontinence surgery

Exclusion Criteria

  • 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Study Arm
  • Drug: Tamsulosin
    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.
    Other names:
    • Flomax
Placebo Comparator
Control Arm
  • Drug: Placebo
    This intervention will ensure blinding and an accurate measure of the real effect of tamsulosin.

Recruiting Locations

TriHealth
Cincinnati, Ohio 45220
Contact:
Jenny Hodge, RN
513-862-2056
Jennifer_Hodge2@trihealth.com

More Details

NCT ID
NCT06843538
Status
Recruiting
Sponsor
TriHealth Inc.

Study Contact

Gisele C Moran, MD, MPH
513-862-1123
gisele_moran@trihealth.com