RecruitingPhase 2NCT04597372

Impact of Tamsulosin on Post-Operative Urinary Retention Following Pelvic Reconstructive Surgery

The Impact of Tamsulosin on Duration of Post-Operative Urinary Retention in Women Undergoing Pelvic Reconstructive Surgery- A Double Blind, Randomized, Placebo-Controlled Study

Sponsor

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Enrollment

154 participants

Start Date

Nov 3, 2021

Study Type

INTERVENTIONAL

Conditions

Urinary Retention Postoperative

Summary

The objective of the study is to determine the effectiveness of postoperative Tamsulosin in reducing the duration of acute postoperative urinary retention (POUR) following pelvic reconstructive surgery through a double blind, randomized placebo-controlled trial.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

years or older
willing and able to provide informed consent
postoperative urinary retention as defined by a failed RGVT prior to hospital discharge
Ability to speak and read English
Tolerate pill ingestion

Exclusion Criteria6

allergy/intolerance to Tamsulosin or sulfa drugs
preoperative history of urinary retention as defined by preoperative post void residual of \>150mL
current use of alpha antagonist medication for hypertension
severe dementia
end stage renal or liver disease
history of severe heart failure or major cardiovascular event in the last 6 months

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Interventions

DRUGTamsulosin

Study drug will contain 0.4 mg of Tamsulosin. Subjects will be provided with 10 capsules to be taken daily.

DRUGPlacebo

Placebo will be prepared by the IDS pharmacist (or contracted pharmacy) and encapsulated in identical appearing wraps. Subjects will be provided with 10 capsules to be taken daily.