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Alpha-1 Adrenergic Receptor Antagonist

Tamsulosin for Urinary Retention

Phase 2

Recruiting

Led By Lindsay Turner, MD

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

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Postoperative urinary retention as defined by a failed RGVT prior to hospital discharge

18 years or older

Must not have

Preoperative history of urinary retention as defined by preoperative post void residual of >150mL

Severe dementia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up date of failed retrograde voiding trial until resolution of post-operative urinary retention or a 10-day course

Summary

This trial will test whether the drug Tamsulosin can reduce the duration of acute urinary retention following pelvic reconstructive surgery.

Who is the study for?

This trial is for adults who can consent, speak English, and swallow pills. They must have postoperative urinary retention after pelvic surgery but no history of it before surgery. Excluded are those with allergies to Tamsulosin or sulfa drugs, on alpha antagonists for high blood pressure, severe dementia, end-stage kidney/liver disease, or recent severe heart issues.

What is being tested?

The study aims to see if Tamsulosin helps reduce the time patients experience acute urinary retention after pelvic reconstructive surgery compared to a placebo. Participants will be randomly assigned to receive either Tamsulosin or a placebo in a double-blind setup where neither they nor the researchers know who gets what.

What are the potential side effects?

Tamsulosin may cause dizziness, headaches, sleepiness, nausea, low blood pressure upon standing up (orthostatic hypotension), and rarely ejaculation problems. The side effects often vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have trouble urinating after surgery.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had issues with not being able to fully empty my bladder before surgery.

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I have severe memory loss that affects my daily life.

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I have end-stage kidney or liver disease.

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I am currently taking medication for high blood pressure.

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I have not had severe heart failure or a major heart event in the last 6 months.

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I am allergic to Tamsulosin or sulfa drugs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ date of failed retrograde voiding trial until resolution of post-operative urinary retention or a 10-day course

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~date of failed retrograde voiding trial until resolution of post-operative urinary retention or a 10-day course

This trial's timeline: 3 weeks for screening, Varies for treatment, and date of failed retrograde voiding trial until resolution of post-operative urinary retention or a 10-day course for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To determine the impact of Tamsulosin on duration of urinary retention

Secondary study objectives

To assess the impact of Tamsulosin on rates of urinary tract infection (UTI).

To quantify the effect of Tamsulosin on patient quality of life.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TamsulosinExperimental Treatment1 Intervention

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.

Group II: PlaceboPlacebo Group1 Intervention

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Tamsulosin

2002

Completed Phase 4

~16790

0 / 8Eligibility criteria met