Pre-operative Tamsulosin and Time to Spontaneous Void After Hysterectomy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-16

Study Completion Date

2023-06-24

Brief Summary

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The aim of this study is to determine if a one time dose of tamsulosin given pre-operatively decreases the time to void and the time to discharge after minimally invasive hysterectomy.

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Detailed Description

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Conditions

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Urinary Retention Postoperative

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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Tamsulosin- intervention group

Group Type EXPERIMENTAL

Tamsulosin

Intervention Type DRUG

Participants will be given Tamsulosin or placebo in the pre-op bay prior to surgery. Post-operatively, time to void and time to discharge from the post-anesthesia care unit will be recorded.

Placebo group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participants will be given Tamsulosin or placebo in the pre-op bay prior to surgery. Post-operatively, time to void and time to discharge from the post-anesthesia care unit will be recorded.

Interventions

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Tamsulosin

Participants will be given Tamsulosin or placebo in the pre-op bay prior to surgery. Post-operatively, time to void and time to discharge from the post-anesthesia care unit will be recorded.

Intervention Type DRUG

Placebo

Participants will be given Tamsulosin or placebo in the pre-op bay prior to surgery. Post-operatively, time to void and time to discharge from the post-anesthesia care unit will be recorded.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Women 18-80 undergoing outpatient minimally invasive hysterectomy

Exclusion Criteria

* Inability to provide informed consent
* Bladder malignancy
* Intra-operative bladder or ureteral injury; anticipated prolonged bladder catheterization
* Plan for sling or anterior repair

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No