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

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
TriHealth Inc.
Study ID
NCT06843538
Phase
PHASE3
Status
Recruiting
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Conditions

  • Postoperative Urinary Retention (POUR)

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tamsulosin — DRUG
    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.
  • Placebo — DRUG
    This intervention will ensure blinding and an accurate measure of the real effect of tamsulosin.

Study Details

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).

Key Dates

Start date
Feb 3, 2025
Status verified
Feb 2025
Primary completion
Feb 1, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
166 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Study Arm
  • Placebo Comparator: Control Arm

Primary Outcome Measure

Voiding trial on postoperative day 0 [ Time Frame: Day of surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
TriHealthCincinnatiOhio45220
Jenny Hodge, RN
[email protected]
513-862-2056
Catrina Crisp, MD, MSc (PRINCIPAL_INVESTIGATOR)

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TriHealth· Cincinnati, OH