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.
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.
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.
- Conditions
- Urinary Retention, Inguinal Hernia
- 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 group | Role | What they receive |
|---|---|---|
| Tamsulosin | Experimental | Patients will then consume oral tamsulosin 0.4mg every morning daily for 5 days prior to elective surgery Receives: Drug: Tamsulosin |
| Placebo | Placebo comparator | Patients 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.
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.
- First posted19 Oct 2017
- Study start1 Dec 2017 (estimated)
- Primary completion1 Dec 2018 (estimated)
- Study completion1 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary RetentionStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Singapore
- Responsible party
- Sponsor
- Investigators
- Lomanto Davide, MD, PhD, FAMS, Principal investigator, National University of Hospital, Singapore
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Alpha-blockers in the Prevention of Post-operative Urinary Retention After Inguinal Hernia Repair: A Randomized Double-Blind Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT03314259
- Acronym / sponsor ID
- 2016/00295-SRF0001
- Conditions
- Urinary Retention, Inguinal Hernia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- National University of Singapore
- Study start
- 1 Dec 2017 (estimated)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 1 Jun 2019 (estimated)
- First posted
- 19 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tamsulosin | Experimental | Drug: TamsulosinPatients will then consume oral tamsulosin 0.4mg every morning daily for 5 days prior to elective surgery |
| Placebo | Placebo comparator | Drug: Placebo Oral TabletPatients will then consume placebo every morning daily for 5 days prior to elective surgery |
Who may qualify
- Ages
- 41 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Males of 41 to 80 years old who are going for elective inguinal hernia repair (laparoscopic or open) under general anesthesia.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TamsulosinTamsulosin 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 | Drug | Tamsulosin |
| Placebo Oral Tabletplacebo is a tablet made to mimic tamsulosin tablet with same size and colour with no active ingredient | Drug | Placebo |
Primary outcome
Post operative urinary retention
Time frame: 6 hours post surgery
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lomanto Davide, MD, PhD, FAMS principal investigator
National University of Hospital, Singapore
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.