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

Allegheny Health Network (AHN)

Status and phase: Enrolling; Phase 2

Conditions: Urinary Retention Postoperative

Treatments: Drug: Placebo; Drug: Tamsulosin

Study type: Interventional

Funder types: Other

Identifiers

NCT04597372

IRB00264995

Details and patient eligibility

About

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.

Full description

The primary objective is to determine the impact of Tamsulosin on duration of urinary retention following pelvic reconstructive surgery in women. Duration of catheterization via indwelling foley or clean intermittent self-catheterization (CISC), measured in days, will be compared between women receiving Tamsulosin versus placebo after diagnosis of postoperative urinary retention via standardized voiding trial. It is hypothesized that women receiving Tamsulosin will have a shorter duration of urinary retention, fewer urinary tract infections, and improved quality of life as compared with placebo. The Euroqol-5D (EQ-5D) will be used to compare physical, emotional, functional, and social/family well-being between women receiving Tamsulosin and placebo.

Upon diagnosis of POUR, women will be offered participation in the study. Once consent is obtained, women will be randomized to tamsulosin 0.4 mg or matching placebo capsules to be used daily until resolution of POUR or a 10 day course, whichever occurs first.

Enrollment: 154 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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154 participants in 2 patient groups, including a placebo group

Tamsulosin

Experimental group

Description:

10 capsules will be distributed to subjects to be taken daily. Each capsule contains 0.4mg of Tamsulosin. Subjects will take the capsule once daily until the end of the 10 day course or until the resolution of acute postoperative urinary retention. Both study drug and placebo will appear identical and will be prepared by the pharmacy.

Treatment:

Drug: Tamsulosin

Placebo

Placebo Comparator group

Description:

10 capsules will be distributed to subjects to be taken daily. Subjects will take the capsule once daily until the end of the 10 day course or until the resolution of acute postoperative urinary retention. Both study drug and placebo will appear identical and will be prepared by the pharmacy.

Treatment:

Drug: Placebo