Use of Tamsulosin ,Deflazacort and Tadalafil for treatment of patients with lower ureteric calculi.

Recruiting

• Conditions: Calculus of ureter,

• Registration Number: CTRI/2019/02/017550
• Lead Sponsor: Dr Jaspreet Singh Sandhu

Brief Summary

A parallel group open labelled randomised  controlled trial to compare the spontaneous passage  of lower ureteric calculi 5-10 mm in size, upon usage of Tamsulosin 0.4 mg alone as control, compared with Tamsulosin 0.4 mg and  Deflazacort 30 mg in one arm and Tamsulosin 0.4 mg ,  Deflazacort 30mg  and Tadalafil 10 mg in the second arm.Patients shall be given the treatment orally, daily for 3 weeks. Patients shall be reviewed weekly, for evidence of passage radiologically.  Those unable to pass their calculi spontaneously,shall be treated by ureteroscopy. Adverse events shall also be monitored.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-02
• Last Update Posted: 2020-07-17

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1Radiologically proven lower ureteric calculi 5-10mm in size 2Normal Renal function tests 3Those without history of any prior ureteric surgery.

Exclusion Criteria

• 1 Infections of the urinary tract(Positive Urine Culture,fever or leucocytosis 2 Grade 3-4 hydronephrosis 3 Diabetes 4 Peptic ulcer disease, 5 History of hypersensitivity to Tadalafil or Corticosteroids 6 Pregnancy.
• 7 Systolic blood pressure less than 110 mm Hg during their first visit..
• 8 History of ureteral surgery 9 Deranged renal function test 10 Patients already on Alfa Blockers.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Spontaneous Expulsion of the lower third ureteric calculus	Patients shall be investigated weekly to confirm spontaneous expulsion,for a total of 3 weeks

Secondary Outcome Measures

Name	Time	Method
Total analgesic consumption	weekly and at 3 weeks
Self assesed pain measurement	Daily and assessed cumulatively at 3 weeks
Drug adverse effect of Orthostatic Hypotension	Earliest appearance and whether causing discontinuation of drug
Drug Adverse effect of Headache	Appearance and whether leading discontinuation of drug
Drug adverse effect of Gastritis	leading to discontinuation of drug or managable with H2 blockers
In men,self assessed improvement in (International Index of Erectile Function(IIEF) Scores	At 03 weeks or whenever discontinuing treatment
Failure to continue medical management, and reasons	Irrespective of time frame

Trial Locations

Locations (1)

Command Hospital Kolkata; 🇮🇳 Kolkata, WEST BENGAL, India

Command Hospital Kolkata

🇮🇳Kolkata, WEST BENGAL, India

Dr Jaspreet Singh Sandhu

Principal investigator

7607082356

sands46jazz@hotmail.com