COMPARISON OF TAMSULOSIN AND SILODOSIN IN TREATMENT OF LOWER URETERIC STONES

Phase 3

Not yet recruiting

Conditions: Calculus of ureter,

Registration Number: CTRI/2019/07/019961

Lead Sponsor: ARUNCHAND R

Brief Summary: 70% ureteric calculus are situated in lower 1/3rd of ureter, referred as Distal Ureteric Stones (DUS). Medical Expulsion Therapy(MET) has replaced minimally invasive procedures due to incidence of major complications including ureteric avulsions, perforation & strictures in the latter.

Uroselective Alfa adrenergic blockers as MET has been accepted as first line management of small lower ureteric calculus as various meta analysis shows stone passage of 44% - 52%. However MET has been associated with side effects including retrograde ejaculation.

Identification of Î±1A adrenoreceptor blocker capable of lesser side effects has been proposed as an alternative to Î±1 adreno receptor blocker.

The objective of study is to compare efficiecy of Tamsulosin vs Silodosin as MET of DUS in terms of stone clearence rate and stone expulsion time.

Randomisation will be achived by Block Randomisation and results are to be compared with appropriate statistical software.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

a) Unilateral distal ureteric calculus b) Size < 10 mm c) Normal renal parameters (Serum Urea & Serum Creatinine) d) Age 18-60 yrs.

Exclusion Criteria

a) Single kidney b) Bilateral ureteric stone c) Mid/upper ureteric calculus d) Renal impairment e) High grade hydroureteronephrosis (Grade III & IV as per Society of Fetal Ultrasound, SFU) f) Any h/o previous endoscopic/ surgical/ ESWL interventions g) Intolerable side-effects (Hypotension) to either tamsulosin/ silodosin h) Evidence of UTI j) Concomitant kidney/bladder stones k) Patients already on any alpha blocker for BPH.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
STONE CLEARENCE RATE (%)	1.Passing of stone \| 2.04 weeks elapsed and surgical intervention planned \| 3.Symptoms of patient demanding interventional procedures

Secondary Outcome Measures

Name	Time	Method
STONE EXPULSION TIME (DAYS)	1.Passing of stone

Trial Locations

Locations (1): ARMED FORCES MEDICAL COLLEGE
🇮🇳
Pune, MAHARASHTRA, India
ARMED FORCES MEDICAL COLLEGE
🇮🇳Pune, MAHARASHTRA, India
ARUNCHAND R
Principal investigator
8547861531
r.arunchand.89@gmail.com