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Hernia surgery drug trial halted early – what it means for patients

NCT ID NCT04491526

Prevention Sponsor: Antonio Nocito, MD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether tamsulosin, a drug used for prostate symptoms, could prevent men from having trouble urinating after hernia repair. The trial planned to include 312 men aged 60 and older, but it was stopped early. Because it was terminated, we cannot draw firm conclusions about whether the drug works for this purpose.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tamsulosin
What this could lead to
If effective, tamsulosin could reduce the need for catheterization after hernia surgery, making recovery easier for men.
What could go wrong
The trial was terminated early, so we don't have clear evidence. Tamsulosin may cause dizziness or low blood pressure in some men.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

312 people

The number who actually took part.

Started

Nov 2020

Finished

Feb 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Males * ≥60 years old * Planned uni- or bilateral endoscopic total extraperitoneal inguinal hernia repair * Surgery scheduled more than 6 days from the time of consent * Informed Consent as documented by signature (Appendix Informed Consent Form) Exclusion Criteria: * Orthostatic hypotension (feeling of dizziness after getting up from a sitting or lying position) * Severe liver disease (Child Pugh C) * Taking strong inhibitors of CYP3A4 (ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir/ritonavir, lopinavir, or conivaptan) * Being on alpha-blockers (alfuzosin, doxazosin, prazosin, terazosin, tamsulosin, phenoxybenzamine, or silodosin) or a combination product containing alpha-blocker (duodart) * History of allergy or sensitivity to tamsulosin or other alpha-blockers (alfuzosin, doxazosin, prazosin, terazosin, or phenoxybenzamine) * Long term Indwelling urinary or suprapubic catheter * Status post cystectomy * Inability to provide informed consent * Known or suspected non-compliance, drug or alcohol abuse, * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant, * Participation in another study with investigational drug within the 30 days preceding and during the present study, * Previous enrolment into the current study

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Conditions

The condition(s) this trial relates to.

Hernia, Inguinal Urinary Retention

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Inguinal hernia Urinary retention

Contacts and locations

Locations

  • Kantonsspital Baden

    Baden, Canton of Aargau, 5404, Switzerland

More trials for these conditions

Other studies related to the condition(s) this trial covers.