An Early Phase 1 interventional study of Tamsulosin. and Placebo. in Ureteric Stone, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-07.
Sponsored by Assiut University · Early Phase 1, Interventional, and Treatment
To estimate the efficacy of tamsulosin in:
A - Expulsion of lower ureteric stones from10-15 mm diameters (primary goal).
B - Pain relief and hyronephrosis improvement (secondary goal).
Urolithiasis affects 4-15% of world population and the incidence of this disease is increasing day by day . Of all the urinary tract stones, 20% are ureteral stones, and 70% of these ureteral stones are found in the distal part of the ureters . The goal of treatment of patients suffering from ureteral calculi is to achieve complete stone clearance with minimal morbidity .
Ureteral calculi of any size may be associated with renal obstruction and care must be taken to prevent irreversible damage to kidney, whether patient selects expectant or active treatment . An expectant treatment or watchful waiting approach may be expected to produce spontaneous stone expulsion up to 50% of cases but some complications such as urinary infection, hydronephrosis, and repetitive colicky pain may occur . Once a conservative approach proves to be unsuccessful, interventional treatment becomes necessary. After a period of conservative treatment, however, intervention is often inefficient or has a higher risk for complications due to stone impaction and the associated inflammatory reaction of the ureter . Non-invasive treatment with extracorporeal shockwave lithotripsy and minimal invasive approach with ureteroscopy allow ureterolithiasis to resolve in almost all cases but these procedures are not risk free and they require some experience and not cost effective .
The therapeutic potential of α-blockers for ureteral stone disease has been investigated, prompted by the detection of α-receptors in ureteral smooth muscle cells . We choose to focus on tamsulosin because it is the most frequently studied α-blocker, recommended in urology treatment guidelines, and, in our experience, the most common medical expulsive therapy used by emergency physicians .
The objective of this trial was to evaluate the efficacy of MET with tamsulosin for ureteral stones from 10-15 mm diameter in a randomised, placebo-controlled setting.
84 studies on the registry are indexed under Ureterolithiasis; 19 are open to participants now.
This study's planned enrollment of 80 is below the median of 101 across 66 interventional studies indexed under Ureterolithiasis.
Browse Ureterolithiasis studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
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Exclusion Criteria:
Patients who will receive tamsulosin as a treatment for lower ureteric stones from (10-15)mm up to 8 weeks duration.e foll The cases will be followed up as thowing: In the first month: abdominal ultrasonography every week, KUB abdomen and pelvis for radiopaque stones. At the end of the second month: abdominal ultrasonography, KUB abdomen and pelvis for radiopaque stones. At the end of the third month: abdominal ultrasonography, KUB abdomen and pelvis for radiopaque stones, MSCT abdomen and pelvis for radiolucent stones.
Drug: Tamsulosin.
Patients who will receive placebo up to 8 weeks duration.The cases will be followed up as following: In the first month: abdominal ultrasonography every week, KUB abdomen and pelvis for radiopaque stones. At the end of the second month: abdominal ultrasonography, KUB abdomen and pelvis for radiopaque stones. At the end of the third month: abdominal ultrasonography, KUB abdomen and pelvis for radiopaque stones, MSCT abdomen and pelvis for radiolucent stones.
Drug: Placebo.
Patients who will receive tamsulosin as a treatment for lower ureteric stones from (10-15)mm up to 8 weeks duration.
Patients who will receive as placebo a treatment for lower ureteric stones from (10-15)mm up to 8 weeks duration.
Theraputic effect of tamsulosin as assessed by number of cases of expulsed ureteric stones.
Patients who will receive tamsulosin as a treatment for lower ureteric stones from (10-15)mm up to 8 weeks duration.e foll The cases will be followed up as thowing: In the first month: abdominal ultrasonography every week, KUB abdomen and pelvis for radiopaque stones. At the end of the second month: abdominal ultrasonography, KUB abdomen and pelvis for radiopaque stones. At the end of the third month: abdominal ultrasonography, KUB abdomen and pelvis for radiopaque stones, MSCT abdomen and pelvis for radiolucent stones.
Time frame: 1year
No study locations are listed for this record.
Start is estimated for Oct 2017; primary completion for Sep 2018, 11 months later.
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This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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