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Inguinal HerniaPhase 1/2NCT03976934

Prophylactic Administration of Alpha Blockers for Prevention of Urinary Retention in Males Undergoing Inguinal Hernia Repair Under Spinal Anaesthesia.

A Phase 1/2 study testing Tamsulosin in people with Inguinal Hernia and Urinary Retention, run by Georgios Koukoulis at 2 sites in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Open inguinal hernia repair is one of the most common surgical procedures. Despite the fact that different of anesthetic procedures are proposed as alternatives to spinal anesthesia, the combination of spinal anesthesia with open inguinal hernia repair is preferred from both surgeons and patients. Read more about this study

Who is it for?
Ages 50 years and older, men only
Conditions the study is for
Inguinal Hernia, Urinary Retention
What is being tested?
Tamsulosin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
2 sitesGreece
Study dates
1 Feb 2020to 30 Oct 2021
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • unilateral inguinal hernia

Who cannot join

  • ASA score >3
  • hypotension
  • prostatic hypertrophy
  • complicated inguinal hernia
  • neurological diseases
  • inguinal hernia repair under general or local anaesthesia

Trial locations and contacts

2 sites in 1 country.

Greece2 sites

  • University General Hospital of Larissa

    Larissa, 41110

  • General Hospital Of Larissa

    Larissa, 41221

Other trials in Greece

About this study

Official title: Prophylactic Administration of Alpha Blockers for Prevention of Post Operative Urinary Retention in Males Undergoing Open Inguinal Hernia Repair Under Spinal Anaesthesia.

Open inguinal hernia repair is one of the most common surgical procedures. Despite the fact that different of anesthetic procedures are proposed as alternatives to spinal anesthesia, the combination of spinal anesthesia with open inguinal hernia repair is preferred from both surgeons and patients. One disadvantage of this combination is the high incidence of post-surgery urinary retention, especially in men above 50 years old. This complication is partially attribute to overstimulation of the a1 adrenergic receivers of the bladder and the prostate. Preoperative administration of elective a1 blockers could inhibit this effect without side effects, since this drugs don't have systemic effect.

Being tested
Tamsulosin, Placebo oral tablet
Keywords
open inguinal hernia repair, spinal anaesthesia, urinary retention, elective alpha blockers
Medical subject headings
Hernia, Inguinal, Urinary Retention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TamsulosinDrug

    Also called omnic tocas

    administration of tamsulosin tablets

  • Placebo oral tabletDrug

    sugar pills

Study groups in NCT03976934
Study groupRoleWhat they receive
Tamsulosin groupActive comparatoradministration of 0,4mg of tamsulosin 24 hours before surgery and 0,4mg 6 hours before surgery
Receives: Drug: Tamsulosin
Placebo groupPlacebo comparatoradministration of placebo 24 and 6 hours before surgery
Receives: Drug: Placebo oral tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. incidence of urinary retention

    inability to voluntarily void urine up to 8 hours post surgery

    Measured: 8 hours post surgery

Secondary outcomes (6)

  1. Prostate related Symptoms

    identification of Prostate related Symptoms as preoperative risk factor of post surgery urinary retention. For the assessment of the prostate related symptomatology will be used the International Prostate Symptom Score questionnaire

    Measured: Baseline

  2. Scrotal hernia Repair

    evaluation of Scrotal hernia repair as preoperative risk factor of post surgery urinary retention.

    Measured: Baseline, Inta-operative

  3. Duration of Surgery

    Evaluation of the surgery duration as inta-operative risk factor of post surgery urinary retention.

    Measured: Duration of Surgical procedure

  4. Use of opioids

    Evaluation of the peri-operative administration of iv opioids as a peri-operative risk factor of post surgery urinary retention.

    Measured: 24 hours

  5. Iv fluid administration

    Evaluation of the peri-operative iv fluid administration as a peri-operative risk factor of post surgery urinary retention.

    Measured: 24 hours

  6. Post-operative Pain

    Evaluation of the post operative pain as a risk factor of post surgery urinary retention. For the assessment of the pain will be used the Visual Analog Scale (VAS) score at 6, 12 and 24 hours after surgery. (VAS Score Scale from 0-10, 0 no pain, 10 max pain)

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2019
  2. Study start1 Feb 2020
  3. Primary completion1 Oct 2021
  4. Study completion30 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03976934
Sponsor's protocol ID
1725
Status last verified
Nov 2021
First submitted
31 May 2019
Last updated
26 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Clancy C, Coffey JC, O'Riordain MG, Burke JP. A meta-analysis of the efficacy of prophylactic alpha-blockade for the prevention of urinary retention following primary unilateral inguinal hernia repair. Am J Surg. 2018 Aug;216(2):337-341. doi: 10.1016/j.amjsurg.2017.02.017. Epub 2017 Mar 14.

    PubMed 28341140

  • Basheer A, Alsaidi M, Schultz L, Chedid M, Abdulhak M, Seyfried D. Preventive effect of tamsulosin on postoperative urinary retention in neurosurgical patients. Surg Neurol Int. 2017 May 10;8:75. doi: 10.4103/sni.sni_5_17. eCollection 2017.

    PubMed 28584678

  • Shaw MK, Pahari H. The role of peri-operative use of alpha-blocker in preventing lower urinary tract symptoms in high risk patients of urinary retention undergoing inguinal hernia repair in males above 50 years. J Indian Med Assoc. 2014 Jan;112(1):13-4, 16.

    PubMed 25935942

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Tamsulosin in people with Inguinal Hernia and Urinary Retention, run by Georgios Koukoulis at 2 sites in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

incidence of urinary retention (time frame: 8 hours post surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03976934, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2021.

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