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

NCT03314259 | Unknown Early Phase 1 DMC

• 1 other identifier: 2016/00295-SRF0001
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Conditions

Urinary Retention; Inguinal Hernia

Outcome Measures

Primary Outcomes (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.

  6 hours post surgery

Study Arms (2)

Tamsulosin

EXPERIMENTAL

Patients will then consume oral tamsulosin 0.4mg every morning daily for 5 days prior to elective surgery

Drug: Tamsulosin

Placebo

PLACEBO COMPARATOR

Patients will then consume placebo every morning daily for 5 days prior to elective surgery

Drug: Placebo Oral Tablet

Interventions

Tamsulosin DRUG

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

Tamsulosin

Placebo Oral Tablet DRUG

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

Placebo

Eligibility Criteria

• Age: 41 Years - 80 Years
• Gender Eligibility Details: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• National University of Singapore: collaborator

MeSH Terms

Conditions

Urinary Retention; Hernia, Inguinal

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Lomanto Davide, MD, PhD, FAMS

  National University of Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lui Su Ann, MBBS, MRCS

CONTACT

+6567795555; su_ann_lui@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double blind, placebo- controlled trial. After establishing the eligibility of the patients and obtaining the necessary informed consent, the research assistant (third party) will provide them with pre-assigned sealed envelopes that contain information with regards to their designated arm. The patients in the intervention arm will then be provided with Tamsulosin, while the rest will be given the placebo in a similar packaging. Blinded personnel would include the study participants and doctors/nurses involved in the surgery and peri-operative care. As such, participants, care providers and outcome assessors would all be blinded in our study. There will be no unmasking in our trial.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: October 19, 2017
• Study Start: December 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: June 1, 2019
• Last Updated: October 19, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share