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CompletedNCT02958878Updated Jul 30, 2019

Preoperative Administration of Tamsulosin for Prevention of Post Operative Urinary Retention in Males Undergoing Elective Inguinal Hernia Repair

A Phase 4 interventional study of Tamsulosin and Placebo Oral Capsule in Postoperative Urinary Retention, sponsored by Ascension Health. Completed. Open to male participants aged 30 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-30.

Sponsored by Ascension Health · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
210
Allocation
Randomized
Ages
30 Years and older
Sex
Male
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Study summary

Double blinded, randomized controlled prospective study looking at 2 preoperative doses of Tamsulosin an alpha-adrenergic blocker in preventing post-operative urinary retention. A previous study was conducted called "Effectiveness of tamsulosin inprevention of postoperative urinary retention: a randomized double-blind-placebo controlled study" This study involved a tertiary care center involving mostly urological surgical procedures. We look to specifically look at inguinal hernia surgeries in males. The aim of this study is to compare the prophylactic effect of tamsulosin with placebo on postoperative urinary retention. The drug is FDA approved for benign prostatic hypertrophy and urinary retention. It is on formulary at Genesys. Currently there is no standard procedure of prophylactic tamsulosin for urinary retention. Most often post operative patients are given tamsulosin to augment smooth muscle relaxation and spontaneous voiding if the patient is having urinary retention post operatively. We often straight catheterize patients once and start tamsulosin with the goal of avoiding urinary retention and future straight catheterizations or placement of foley catheters

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Conditions studied

  • Postoperative Urinary Retention
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In context

Lead sponsor

Ascension Health is the lead sponsor of 21 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • healthy males, who are not taking Tamsulosin regularly who are undergoing elective inguinal hernia repair (laparoscopic, open, and robotic assisted)

Exclusion criteria

Exclusion Criteria:

  • Patients who are already taking tamsulosin, terazosin (alpha blocker treatement for BPH) , finasteride, dutasteride ( both 5 alpha reductase inhibitors), sulfa allergy, and lactose allergy
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Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
210 participants (actual)

Study arms

  • Experimental
    A

    Tamsulosin 0.4mg given the night before surgery and another dose the day of surgery in the morning.

    Drug: Tamsulosin

  • Placebo comparator
    B

    Placebo medication given the night before surgery and another dose the day of surgery in the morning

    Drug: Placebo Oral Capsule

Interventions

  • Also known as: Flomax

  • DrugPlacebo Oral Capsule
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What researchers measure

Primary outcomes

  1. number of Urinary Retention

    If patients have urinary retention post operatively

    Time frame: within 72 hours of surgery

Secondary outcomes

  1. placebo vs tamsulosin

    Time frame: within 72 hours of surgery

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02958878
Lead sponsor
Ascension Health
Responsible party
Anthony Tabatabai (General Surgery Resident, Ascension Health) — Principal investigator
First posted
Nov 8, 2016
Start date
Jan 3, 2017
Primary completion
Nov 30, 2018
Completion
Nov 30, 2018
Last update
Jul 30, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Tamsulosin

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