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Clinical Trials/CTRI/2025/08/092492
CTRI/2025/08/092492
Not yet recruiting
Phase 2

A comparative study on the effect of Tamsulosin versus Silodosin in post operative urine retention

Dr Vigneshwaran B1 site in 1 country334 target enrollmentStarted: August 16, 2025Last updated:

Overview

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Dr Vigneshwaran B
Enrollment
334
Locations
1
Primary Endpoint
To evaluate the effect of prophylactic Tamsulosin versus Silodosin in post operative retention of urine

Overview

Brief Summary

Those fulfilling the above inclusion and are not in the exclusion criteria will be participants of the study. The participants will be alternatively divided into two groups. The following investigations were carried out in all patients participating in this study i.e. complete blood count, blood urea and serum creatinine, total serum bilirubin, ALP, SGOT, SGPT, ECG, Chest X Ray-PA view, Urine routine, Ultrasound abdomen and pelvis. Patients of General Surgery undergoing abdominal, pelvic, perineal surgeries are given drug prophylaxis either Silodosin in the form 8 mg tablet or Tamsulosin 0.4 mg 12 hours before the procedure to patients. Group A will be given Silodosin . Group B is Tamsulosin. All patients were closely followed for 24 hours post operatively and any voiding difficulties or urinary retention were recorded. Acute urinary retention was diagnosed when a patient was unable to pass urine, feels pain, has a palpable mass in suprapubic region and encouraging the patient to stand up and walk were unsuccessful and urethral catheterization seemed inevitable. The functional outcome will be evaluated based on VAS score in case of Postoperative urine retention, need for urethral catheterization.

Study Design

Study Type
Interventional
Allocation
Other
Masking
Participant Blinded

Eligibility Criteria

Ages
40.00 Year(s) to 99.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients above 40 years of both sexes
  • Patients undergoing abdomen, pelvic, perineal surgeries
  • Patients anaesthetized by general and spinal anaesthesia.

Exclusion Criteria

  • Patients with symptomatic benign prostate hypertrophy
  • Renal impairment, hepatic impairment
  • Previous neurological disease
  • Urethral stricture, urinary incontinency
  • Patients with indwelling catheter
  • Patients with serum creatinine greater than 1.6mg/dl
  • Prostate cancer, bladder cancer
  • Cardiac related ill patients.

Outcomes

Primary Outcomes

To evaluate the effect of prophylactic Tamsulosin versus Silodosin in post operative retention of urine

Time Frame: Till postoperative period of 24 hours

Secondary Outcomes

  • To assess the incidence of catheterisation following surgeries with prophylactic Tamsulosin versus Silodosin under general and spinal anesthesia(Till postoperative period of 24 hours)

Investigators

Sponsor
Dr Vigneshwaran B
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Vigneshwaran B

Sri Manakula Vinayagar Medical College and Hospital, Puducherry

Study Sites (1)

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