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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
Tolerate pill ingestion
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
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 can swallow pills.
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I am 18 years old or older.

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
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To determine the impact of Tamsulosin on duration of urinary retention
Secondary outcome measures
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

Find a Location

Who is running the clinical trial?

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)Lead Sponsor
47 Previous Clinical Trials
12,925 Total Patients Enrolled
Johns Hopkins UniversityOTHER
2,246 Previous Clinical Trials
14,816,616 Total Patients Enrolled
1 Trials studying Urinary Retention
100 Patients Enrolled for Urinary Retention
Lindsay Turner, MDPrincipal InvestigatorAllegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
1 Previous Clinical Trials
150 Total Patients Enrolled
1 Trials studying Urinary Retention
150 Patients Enrolled for Urinary Retention

Media Library

Tamsulosin (Alpha-1 Adrenergic Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04597372 — Phase 2
Urinary Retention Research Study Groups: Placebo, Tamsulosin
Urinary Retention Clinical Trial 2023: Tamsulosin Highlights & Side Effects. Trial Name: NCT04597372 — Phase 2
Tamsulosin (Alpha-1 Adrenergic Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04597372 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What precautionary measures should be taken when utilizing Tamsulosin?

"The safety of Tamsulosin was given a rating of 2 on the scale since this Phase 2 trial has data that attests to its security, but there is an absence of evidence for effectiveness."

Answered by AI

Is recruitment still open for participation in this medical experiment?

"According to the particulars available on clinicaltrials.gov, this medical trial is actively searching for suitable volunteers. It was initially posted in November 2021 and recently amended in 2022."

Answered by AI

What clinical applications is Tamsulosin typically used for?

"Tamsulosin has been identified as a viable treatment for bladder outlet obstruction, ureteral calculus, and the common condition of benign prostatic hyperplasia (BPH)."

Answered by AI

Are there any past experiments that have tested the efficacy of Tamsulosin?

"At the current moment, 13 separate studies are underway in regards to Tamsulosin. Of these trials, 3 have progressed into Phase 3 testing. Most of them are situated around Baden and Aargau; however, a total number of 13 locations across the globe are running experiments on this drug."

Answered by AI

To what number of participants is the research team recruiting?

"Affirmative. The records on clinicaltrials.gov indicate that this medical trial, initially published on November 3rd 2021, is in the process of sourcing participants. In total, 154 individuals are needed from 1 particular location."

Answered by AI
~34 spots leftby Dec 2024