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NCT Number: NCT06843538

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

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).

Recruiting

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Key information

Conditions

Postoperative Urinary Retention (POUR)

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

TriHealth

Cincinnati, Ohio, 45220, United States

Location status: Recruiting

Location contact

Catrina Crisp, MD, MSc

PRINCIPAL_INVESTIGATOR

Jenny Hodge, RN

CONTACT

[email protected]

513-862-2056

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Flomax

Placebo

Drug

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

Primary outcomes

  1. Voiding trial on postoperative day 0

    Time frame: Day of surgery

    Whether or not patients pass or fail their postoperative voiding trial

Secondary outcomes

  1. Secondary postoperative urinary retention

    Time frame: 2 weeks following surgery

    Patients who develop urinary retention after discharge

  2. Postoperative urinary tract infection

    Time frame: 30 days after surgery

    Patients who develop a urinary tract infection after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Gisele C Moran, MD, MPH

CONTACT

[email protected]

513-862-1123

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 25, 2025
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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