An Early Phase 1 interventional study of Tamsulosin and Placebo Oral Tablet in Urinary Retention and Inguinal Hernia, sponsored by National University Hospital, Singapore. Status unknown. Open to male participants aged 41 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-19.
Sponsored by National University Hospital, Singapore · Early Phase 1, Interventional, and Prevention
Among 26 studies testing tamsulosin in Urinary Retention — 7 open to participants now, 7 under way, 2 of them phase 3. Tamsulosin · Urinary Retention.
Among the 26 studies testing tamsulosin in Urinary Retention, this one is the 2nd largest by planned enrollment, is one of 5 that started in 2017, is one of 3 in phase 1, and was the 10th registered.
241 studies on the registry are indexed under Urinary Retention; 44 are open to participants now.
This study's planned enrollment of 300 is above the median of 90 across 187 interventional studies indexed under Urinary Retention.
Browse Urinary Retention studies →7 of the 26 studies testing tamsulosin in Urinary Retention are open now, in 3 countries. Each count lists the studies.
Tamsulosin: first FDA approval 1997 (FLOMAX). What it is approved for, and how studies give it, is on its page →
Of the 31 Urinary Retention studies recruiting now, 23 (74%) set no upper age limit and 5 (16%) stop at 75 or younger; 1 take children under 18; 7 take healthy volunteers.
This study: 41 Years to 80 Years · male · healthy volunteers too.
The full table on the hub →26 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 5 started in 2017.
Median enrollment 136 across the 26 interventional studies. Of the 16 that completed or were terminated, 9 (56%) have results posted.
1 of 26 have an industry lead sponsor. The 10 most frequent:
National University Hospital, Singapore is the lead sponsor of 454 studies on the registry; 99 are open to participants now.
National University Hospital, Singapore has 1 study filed under Urinary Retention — fewer than ten, so there is no comparison to draw.
4 of the studies testing tamsulosin in Urinary Retention that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05941806Phase 3CHU de Quebec-Universite LavalProphylactic Use of Tamsulosin in the Prevention of Post-operative Urinary Retention in Men After Rectum Resection | 2027-07-30 |
| NCT04597372Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)Impact of Tamsulosin on Post-Operative Urinary Retention Following Pelvic Reconstructive Surgery | 2026-12 |
| NCT07174349Mayo ClinicUroselective Alpha-1-Antagonist to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery | 2027-01-31 |
| NCT05657990Hackensack Meridian HealthPost Operative Urinary Retention (POUR) Following Thoracic Oncological Surgery | 2027-06 |
Among the 26 studies testing tamsulosin in Urinary Retention, from their registry updates:
Nothing recorded among them since 2026-09-25.
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
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.
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.
Exclusion Criteria:
Patient whom has any of the following will be excluded:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will then consume oral tamsulosin 0.4mg every morning daily for 5 days prior to elective surgery
Drug: Tamsulosin
Patients will then consume placebo every morning daily for 5 days prior to elective surgery
Drug: Placebo Oral Tablet
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 is a tablet made to mimic tamsulosin tablet with same size and colour with no active ingredient
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.
Time frame: 6 hours post surgery
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2017; primary completion for Dec 2018, 12 months later.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tamsulosin
National University Hospital, Singapore →