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

TriHealth

Status and phase: Enrolling; Phase 3

Conditions: Postoperative Urinary Retention (POUR)

Treatments: Drug: Tamsulosin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06843538

24-108

Details and patient eligibility

About

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).

Enrollment: 166 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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166 participants in 2 patient groups, including a placebo group

Study Arm

Active Comparator group

Treatment:

Drug: Tamsulosin

Control Arm

Placebo Comparator group

Treatment:

Drug: Placebo