AzTrials
AzTrials

Urinary RetentionEarly Phase 1NCT03314259

Prophylactic Alpha-blockers in the Prevention of Urinary Retention Post Inguinal Hernia Repair

A Early Phase 1 study testing Tamsulosin in people with Urinary Retention and Inguinal Hernia, run by National University Hospital, Singapore.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Post operative urinary retention ( POUR) is caused by sympathetic activation of the internal urethral sphincter after surgery. The smooth muscles of the around the internal urethral sphincter have been demonstrated to be rich in alpha-1 adrenergic receptors. Read more about this study

Who is it for?
Ages 41 to 80 years, men onlyHealthy volunteers can take part
Conditions the study is for
Urinary Retention, Inguinal Hernia
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
300 participants
Where
No sites listed yet
Study dates
1 Dec 2017to 1 Jun 2019
Phase
Early Phase 1
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 41 to 80 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Males of 41 to 80 years old who are going for elective inguinal hernia repair (laparoscopic or open) under general anesthesia.

Who cannot join

  • Patient whom has any of the following will be excluded:
  • Contraindication to tamsulosin : known allergy, known orthostatic hypotension, significant cardiac co-morbidities ( New york heart association functional classification >2) or heart failure
  • End stage renal failure
  • More than two anti-hypertensive use/long term alpha blockers/beta blockers/anticholinergic (eg : buscopan)
  • Previous urological or pelvic surgery
  • Known benign prostatic hyperplasia on medications
  • Long term indwelling catheters
  • Concurrent neurologic disease such as stroke, poliomyelitis, cerebral palsy, multiple sclerosis, spinal lesions, diabetic and alcoholic neuropathy

Trial locations and contacts

No sites are listed yet.

Lui Su Ann, MBBS, MRCS contact

+6567795555

su_ann_lui@nuhs.edu.sg

About this study

Official title: Prophylactic Alpha-blockers in the Prevention of Post-operative Urinary Retention After Inguinal Hernia Repair: A Randomized Double-Blind Placebo-Controlled Trial

Post operative urinary retention ( POUR) is caused by sympathetic activation of the internal urethral sphincter after surgery. The smooth muscles of the around the internal urethral sphincter have been demonstrated to be rich in alpha-1 adrenergic receptors. Our research idea is novel because there has been no prior prospective study conducted using alpha-blockers to reduce post-operative urinary retention in patients undergoing inguinal hernia repair. The proposed research is important as existing studies that sought to understand POUR have merely established the risks factors involved. Despite so, the incidence of POUR remains high and no studies to date have investigated the use of specific interventions to reduce the risk of POUR.

This is essential as patients who develop POUR have also been successfully shown to have significantly longer length of hospitalisation. Besides, the development of POUR can also cause significant pain/discomfort, increase risks of long-term urethral catheterisation and predispose patients to urinary tract infections

Read the detailed description

The study will be conducted as a randomised, double blind, placebo-controlled trial. This is a single center trial. The experimental design and procedure will be performed in accordance to the CONSORT guidelines. Patients will be assessed for eligibility, and selected based on the inclusion and exclusion criteria. Once eligible, informed consent will be obtained for every patient, and those in agreement to the participation of the trial will be randomly provided with pre-assigned sealed envelopes containing either tamsulosin or placebo, for which patient and investigators will be blinded to. Patients will then consume either oral tamsulosin 0.4mg or placebo daily for 5 days prior to elective surgery. A baseline postural blood pressure measurement will be taken before and after the 1st dose, and patients will be informed to look out for symptoms of hypersensitivity reactions and orthostatic hypotension, and to cease consumption should they develop. Prior to surgery, the patients will require to report to the study team if they had finished all 5 drug doses. Patients who develop intercurrent illnesses or have urgent matters at hand that would require their surgery to be postponed will receive another 5 drug doses that is to be consumed prior the their next scheduled surgical date. During the surgery, a maximum dose of 0.1mg/kg of morphine can be given to patients. No ilioinguinal block will be performed for patients, but local anesthesia 10mls 0.5% Bupivacaine will be infiltrated into the wound sites. The patients will then be monitored in the 23 hour short stay ward, during which the patient's wound site, scrotum, pain levels and ability to pass urine will be assessed prior to being discharged. All patients will be provided with a maintenance drip post operatively. Patients will also be placed on paracetamol 1g 6 hourly strictly and tramadol 50mg 8 hourly as per required. Alternative analgesia will be provided should patients have existing allergies to these drug classes.

Patients will be assessed for presence of voiding difficulty 6 hours post operatively, and patients who complain of voiding difficulty or inability to pass urine within 6 hours post operatively will be defined to have POUR, while a bladder scan will be performed will be performed . Patients with existing bladder volume of more than 400mls will be catheterised, while those with less than 400mls will be followed up with subsequent 2 hourly bladder scans, and catheterised should their bladder volume be beyond 400mls. Once discharged, patients will receive a phone call at 24 hours post discharge and scheduled to return for a follow up appointment 1 weeks later in the clinic where urinary symptoms will once again be assessed in both settings. The end points of incidence of POUR/catheterisation, length and cost of hospitalisation, rates of same day discharge, and patient satisfaction in both arms will be recorded and analysed. Patients will be analysed via an intention to treat basis, and patients who defaulted treatment (did not receive full 5 doses of medicine), did not turn up for surgery or lost to subsequent follow up post operatively will be taken into account, and reported and analysed accordingly.

Being tested
Tamsulosin, Placebo Oral Tablet
Medical subject headings
Urinary Retention, Hernia, Inguinal

What participants receive

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

  • TamsulosinDrug

    Tamsulosin is a alpha blocker and has a good safety profile that has been used extensively in Urological patients. Potential safety issues would include a minimal risk of orthostatic hypotension and hypersensitivity reaction to tamsulosin in our study population

  • Placebo Oral TabletDrug

    placebo is a tablet made to mimic tamsulosin tablet with same size and colour with no active ingredient

Study groups in NCT03314259
Study groupRoleWhat they receive
TamsulosinExperimentalPatients will then consume oral tamsulosin 0.4mg every morning daily for 5 days prior to elective surgery
Receives: Drug: Tamsulosin
PlaceboPlacebo comparatorPatients will then consume placebo every morning daily for 5 days prior to elective surgery
Receives: Drug: Placebo Oral Tablet

What is being measured

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

  1. Post operative urinary retention

    patients who complain of voiding difficulty or inability to pass urine within 6 hours post operatively will be defined to have POUR, while a bladder scan will be performed . Patients with existing bladder volume of more than 400mls will be catheterised, while those with less than 400mls will be followed up with subsequent 2 hourly bladder scans, and catheterised should their bladder volume be beyond 400mls.

    Measured: 6 hours post surgery

Timeline

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

  1. First posted19 Oct 2017
  2. Study start1 Dec 2017 (estimated)
  3. Primary completion1 Dec 2018 (estimated)
  4. Study completion1 Jun 2019 (estimated)

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
Early Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03314259
Sponsor's protocol ID
2016/00295-SRF0001
Other IDs
2016
Status last verified
Sep 2017
First submitted
5 Sep 2017
Last updated
19 Oct 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Tamsulosin in people with Urinary Retention and Inguinal Hernia, run by National University Hospital, Singapore.

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 8 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: status not confirmed, as of the sponsor's last update on 19 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

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 phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Lui Su Ann, MBBS, MRCS (+6567795555, su_ann_lui@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post operative urinary retention (time frame: 6 hours post surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 19 Oct 2017.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in