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

NCT ID: NCT06843538

Last Updated: 2025-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-03

Study Completion Date

2026-06-01

Brief Summary

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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).

Detailed Description

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Conditions

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Postoperative Urinary Retention (POUR)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Study Arm

Group Type ACTIVE_COMPARATOR

Tamsulosin

Intervention Type 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.

Control Arm

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Flomax

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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TriHealth Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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TriHealth

Cincinnati, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Gisele C Moran, MD, MPH

Role: CONTACT

513-862-1123

Facility Contacts

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Jenny Hodge, RN

Role: primary

513-862-2056

Other Identifiers

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24-108

Identifier Type: -

Identifier Source: org_study_id

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