A Phase 1/2 interventional study of Tamsulosin and Placebo oral tablet in Inguinal Hernia and Urinary Retention, sponsored by Georgios Koukoulis. Completed at 2 sites in Greece. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2021-11-26.
Sponsored by Georgios Koukoulis · Phase 1/2, Interventional, and Prevention
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.
235 studies on the registry are indexed under Urinary Retention; 39 are open to participants now.
This study's enrollment of 100 is close to the median of 95 across 185 interventional studies indexed under Urinary Retention.
Browse Urinary Retention studies →This is the only study on the registry with Georgios Koukoulis as lead sponsor.
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Exclusion Criteria:
administration of 0,4mg of tamsulosin 24 hours before surgery and 0,4mg 6 hours before surgery
Drug: Tamsulosin
administration of placebo 24 and 6 hours before surgery
Drug: Placebo oral tablet
administration of tamsulosin tablets
Also known as: omnic tocas
sugar pills
incidence of urinary retention
inability to voluntarily void urine up to 8 hours post surgery
Time frame: 8 hours post surgery
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
Time frame: Baseline
Scrotal hernia Repair
evaluation of Scrotal hernia repair as preoperative risk factor of post surgery urinary retention.
Time frame: Baseline, Inta-operative
Duration of Surgery
Evaluation of the surgery duration as inta-operative risk factor of post surgery urinary retention.
Time frame: Duration of Surgical procedure
Use of opioids
Evaluation of the peri-operative administration of iv opioids as a peri-operative risk factor of post surgery urinary retention.
Time frame: 24 hours
Iv fluid administration
Evaluation of the peri-operative iv fluid administration as a peri-operative risk factor of post surgery urinary retention.
Time frame: 24 hours
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)
Time frame: 24 hours
Plan to share: No
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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